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FEATURES toxic, stable08. and safePlant to use, which Based Excipients – The Case of Strychnos suggests their use in targeted drug potatorum Seed Polysaccharide Nanoparticles delivery systems, can profoundly affect the immune system and-Mohammad therefore have Mansour Saleh Saif, Department of Chemistry, the potential as immunomodulators with Faculty of Science, Ibb University, Ibb, Yemen; Nadimpalli wide clinical applications.

Many of the polysaccharides have specific Sivareceptors Kumar, Department of Biochemistry, University of on the cells so they can be easily Hyderabad; Majeti Narasimha Vara Prasad, Department taen by the cells, it was reported that hyaluronic acid (HA) was

by HAScience, University of Hyderabad oftaken Plant specific receptor-mediated endocytosis, and HA was suitable for the targeted Pain Point to Gaining Brownie Points: Technology is a drug delivery 18. systems via their specific receptor. Some glycoproteins are known Game Changer for Indian Pharma Sector to be suitable for the receptor-mediated Angrish, Founder & CEO, CAREDOSE drug delivery systems. -Gauri It was reported that the mannosylated, fucosylated, 20. liposomes Factors and galactosylated showed that are Leading to Moderation in Indian high accumulation in thePharmaceutical liver via each Industry Export Growth Rate Figure 1: Plant based excipients of pharmaceutical importance specific receptor. Polysaccharides have -Vidhayasagar L, Associate Director – Corporate Ratings; been successfully used as drug carriers due to their superior D properties and Kumar, Senior Manager – Corporate Ratings, Naveen biocompatibility. The polysaccharides CARE Ratings Ltd can have linear, branched or cyclic structures containing residues of only Is Telemedicine Sector Ready to Replace Conventional one type of 24. monosaccharides or of different types of monosaccharides.

The System in New Digital India?

Treatment polymers of one type of monosaccharide -Dr Subroto Ghoshal, PhD, Senior Manager - Human units are called homopolysaccharides (e.g. cellulose, starch, Resources, etc) and those Mindteck containing different monosaccharide units are known as heteropolysaccharides (e.g., glucomannans: polymers of EXPERT’S TAKE glucose and mannose, galactomannans: polymers of galactose and mannose 28. “Satara sugars, Cyclodextrins(CD) are cyclicPlant will allow us to expand service offering polysaccharide with six or glucose while strengthening our commitment to local inmore India, units arranged on a doughnut shaped manufacturing and support” ring. Depending on their structure, monomer composition and-Alex conformations, Alcala, President; Andrew Powell Vice President / polysaccharides show different physical General Manager; Hari Jinaga MD and India President, Figure 2: S. potatorum tree, flowers, fruits, seeds and seed powder and chemical properties. Although & Energy l a r g e v a r i e t i e s o f p oCRANE l y s a c c h a r i d e ChemPharma s structures and properties all performing of some of the polysaccharides with other have a multitude of industrial uses, in a large variety of functions of great synthetic and biopolymers have further many cases they need to be further significance. They can also easily increased their range of applicability. The modified to improve their applicability undergo chemical and biochemical versatility in the structure and properties of a c r o s s t h e 31. w i d e s p e MARKET c t r u m o f e n d - RESEARCH modification to generate novel products the polysaccharides and their derivatives, uses. In the last few decades, wide with unique rheological and applicative along with their modifications find ranges of chemical derivatives of theseResults Preview: Still Not Out of the Woods 3QFY18 properties. They are found in abundance, widespread applications including food polysaccharides were developed. The widely available, inexpensive, and able cosmetics petroleum and pharmaceutical Amey the Chalke, HDFC Securities Institutional Research chemical modifications- improved to select some properties according to industries. Moreover polysaccharides rheological properties of their solutions their monosaccharides. The interactions are hydrophilic, biodegradable, non

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Plant Based Excipients – The Case of Strychnos potatorum Seed Polysaccharide Nanoparticles This article focuses on the possible application of Strychnos potatorum seed polysaccharide nanoparticles as pharmaceutical excipient.

B

iodiversity provides a variety of resouces for survival and susten nce of human kind particularly for health care. In this regard plant based excipients play a key role in formulating ef ficient drug delivery mechanisms.

Selected examples of botanical excipients are listed below.

Aloevera - Liliaceae - Gelling agent, emollient, sustained release of drug Anacardium occidentale - Anacardiaceae Suspending agent Anogeissus latifolia – Myrtaceae - Ghutti gum Boswellia serrata - Burseraceae - resin Firmina simplex - Sterculiaceae - Chacolate tree Leucaena leucocephala – Fabaceae Mimosoidae – seed emusifying agent Oscimum – Lamiaceae - seed - suspending agent

Mohammad Mansour Saleh Saif Department of Chemistry, Faculty of Science, Ibb University, Ibb, Yemen

Senna tora - Fabaceae - Caesalpinioideae - Binding agent Trigonella foenum-graecum – Fabaceae -seed gelling agent Strychnos potatorum and Sterculia urens (Gum karaya) are two natural products of global importance that came to lime light because of traditional knowledge.

This write-up deals with only Stychnos potatorum L.

Nadimpalli Siva Kumar Department of BiochemistryUniversity of Hyderabad, Hydrabad

Majeti Narasimha Vara Prasad Department of Plant Science University of Hyderabad, Hydrabad 8 ◄ May 2018

Strychnos potatorum L. (Loganiaceae).

It is a common tree of medicinal importance in India. It is popularly used to purify drinking water. Past traditions in India reported the use of S. potatorum seeds for cleaning the turbid water. S. potatorum is non-toxic plant and its seeds (popularly known as cleaning nuts) have high economic importance. Its seeds are one of the most important minor forest pr oducts collected by the members of the Girijan C o-operative C orporation, Andhra Pradesh (the predominant participating tribal groups are Bagatas,

Valmikis, Nookadoras, Malis, and Kutias) along with other minor forest produc. A commercial product by name “NATFLOC” a “natural polyelectrolyte” has been developed with the seeds of S. potatorum by the GCC. NATFLOC is recommended for water turbidity removal up to 3000 NTU (Nephelometric Turbidity Unit).

Additionally, there are many traditional and medic inal appl ic ati ons of the S. potatorum, in Ayurveda, Siddha, Unani, Folk, Modern, Tibetan and Homeopathy Systems of medicine.

Strychnos potatorum Polysaccharide - Applications

Seed

There is a growing interest in the u se o f p o lysa cch a r id e s d u e t o t h e ir biocompatible, biodegradable and environmentally benign characteristics. Polysaccharides are high molecular weight polymers constituted with simple su gar mo nomer s such as glucose, fructose, galactose and mannose. They are abundant in nature, universally found in almost all living organisms. They are present in various tissues of seeds, stems and leaves of plants, body fluids of animals, shells of crustaceans and insects. They are also found in the cell walls and extra cellular fluids of bacteria, yeast and fungi and are thus renewable reservoirs for synthesizing high performance materials. Polysaccharides have complex structures and they are the most abundant of many natural products and the source of most of the biological energy. They consist of monosaccharides linked together

by O-glycosidic linkages, and diversification of their monosaccharides yields a var ie ty of p r o p er t ies. A lt h ou gh t he y are made up of single type of building blocks, their enormous diversity has led to a bewildering variety of species, structures and properties all performing a large variety of functions of great significance. They can also easily undergo chemical and biochemical modification to generate novel products with unique rheological and applicative properties. They are found in Pharma Bio World

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Figure excipients of pharmaceutical importance Figure1:1: Plant Plantbased based excipients of pharmaceutical importance Figure 1: Plant based excipients of pharmaceutical importance

Figure powder Figure2:2: S. S.potatorum potatorumtree, tree,flowers, flowers,fruits, fruits,seeds seedsand andseed seed powder Figure 2: S. potatorum tree, flowers, fruits, seeds and seed powder

abundance,and widely available, all inexpensive, and structures properties performing able to select some properties according structures and properties all performing a large variety of functions of greatto The some satheir i glarge n i monosaccharides. f i c avariety n c e . T hofe yfunctions c a ninteractions a l s oofe agreat sily of the polysaccharides with other synthetic s i g n i f i c a n c e .

T h e y c a n a l s o e a ial yl u n d e r g o c h e m i c a l a n d b i o c h e m i scand biopolymers have further increased their range u n d e r g o c h e m i c a l a n d b i o c h e m i c al modification to generate novel products of applicability.

The versatility in the structure modification to generate novel products with unique rheological and applicative and unique properties ofare thefound polysaccharides and with rheological and applicative properties.

They in abundance, their derivatives, along with their modifications properties.

They are found in abundance, widely available, inexpensive, and able findselect widespread applications including food widely available, inexpensive, and able to some properties according to cosmetics petroleum and pharmaceutical to select some properties according to their monosaccharides. The interactions their monosaccharides. The interactions 10 ◄ May Pharma Bio2018 World Pharma Bio World

industries.

Moreover polysaccharides are of some of the polysaccharides with other hydrophilic, biodegradable, non toxic, stable of some of the polysaccharides with other synthetic and biopolymers have further and safe to and use, biopolymers which suggestshave their further use in synthetic increased their range of applicability.

The targeted drugtheir delivery systems, can profoundly increased range of applicability. versatility in the structure and propertiesThe of affect the immune system and have versatility in the structure andtherefore properties the polysaccharides and their derivatives,of the potential as immunomodulators with wide athe l o npolysaccharides g w i t h t h e i r mand o d itheir f i c a tderivatives, ions find clinical applications. a l o n g w i t h applications t h e i r m o d i fincluding i c a t i o n s food find widespread widespread applications including food Many of the polysaccharides have specific cosmetics petroleum and pharmaceutical cosmetics on petroleum and receptors the cells sopharmaceutical they can be industries.

Moreover polysaccharides easily taken by the cells, it was reported industries.

Moreover polysaccharides are hydrophilic, biodegradable, non are hydrophilic, biodegradable, non

toxic, stable and safe to use, which toxic, stable acid and(HA) safewas to taken use, by which that hyaluronic HA suggests their use in targeted drug suggests their use in targeted drug specific systems, receptor-mediated endocytosis, delivery can profoundly affect delivery systems, can for profoundly affect and HA was suitable the targeted the immune system and therefore have the immune system and therefore have drug delivery systems via their specific the potential as immunomodulators with the potential as glycoproteins immunomodulators with receptor.

Some are known wide clinical applications.

Many of the Many of the towide be clinical suitable applications. for the receptor-mediated polysaccharides have specific receptors polysaccharides have specific receptors odrug n t hdelivery e c e l l s systems. s o t h e y Itc awas n b ereported easily o n t hthe e c e lmannosylated, l s s o t h e y c a nfucosylated, be easily that taen by the cells, it was reported that taen galactosylated by the cells, it liposomes was reported that and hyaluronic acid (HA) was takenshowed

by HA hyaluronic acid (HA) was taken HA high accumulation in the via by each specific receptor-mediatedliver endocytosis, specific receptor. receptor-mediated endocytosis, specific Polysaccharides have and HA was suitable for the targeted and HA was suitable for drug the targeted been successfully used as carriers drug delivery systems via their specific drug todelivery via their specific due their systems properties and receptor.

Somesuperior glycoproteins are known receptor. Some glycoproteins are known biocompatibility.

The polysaccharides to be suitable for the receptor-mediated to behave suitable for the receptor-mediated can linear, branched or cyclic drug delivery systems. It was reported drug delivery systems.

It was of reported structures containing residues only that the mannosylated, fucosylated, that type the mannosylated, fucosylated, one of monosaccharides or of and galactosylated liposomes showed and galactosylated liposomes showed different types of monosaccharides.

The high accumulation in the liver via each high accumulation liver via each polymers of one typeinofthe monosaccharide specific receptor. Polysaccharides have specific Polysaccharides have units arereceptor. called used homopolysaccharides been successfully as drug carriers been successfully used as drug carriers (e.g. tocellulose, starch, properties etc) and those due their superior and due to their superior propertiesunits and containing different monosaccharide biocompatibility. The polysaccharides biocompatibility.

The polysaccharides are knownlinear, as heteropolysaccharides can have branched or cyclic can have linear, branched or cyclic (e.g., glucomannans: polymers of structures containing residues of only structures containing residues of only glucose galactomannans: one typeandof mannose, monosaccharides or of one type ofof galactose monosaccharides or of polymers and mannose different types of monosaccharides.

The different types of monosaccharides.

The sugars, Cyclodextrins(CD) are cyclic polymers of one type of monosaccharide polymers of one type polysaccharide with sixoformonosaccharide more glucose units are called homopolysaccharides units are called homopolysaccharides units cellulose, arranged on a doughnut (e.g. starch, etc) andshaped those (e.g. cellulose, starch, etc) and those ring.

Depending on monosaccharide their structure, containing different containing different monosaccharide monomer composition and conformations, units are known as heteropolysaccharides units show (polysaccharides e . g . ,are g lknown u c o m aas n nheteropolysaccharides a n sdifferent : p o l y mphysical ers of ( e . g . , g l u c o m a n n a n s : p o l y m ers of and chemical properties. glucose and mannose, galactomannans: glucose and galactomannans: polymers of mannose, galactose and mannose Although large varieties of polysaccharides polymers of galactose andare mannose sugars, Cyclodextrins(CD) have a multitude of industrial uses, incyclic many sugars, Cyclodextrins(CD) are cyclic polysaccharide with six or more glucose cases they need to be further modified polysaccharide with six or more glucose units arranged on a doughnut shaped to improve their applicability across the arranged a doughnut shaped riunits ng. De pendi ngonon their structure, wide of end-uses.

Ins t the r ing.spectrum Depending their ruc tlast ure, monomer compositiononand conformations, few decades, wide ranges of chemical monomer composition conformations, polysaccharides show and different physical derivatives of theseshow polysaccharides were polysaccharides different a n d c h e m i c a l p r o p e r t i e s . A l tphysical hough developed.

The chemical modifications l aa nr gde cvhaermi ei ct iaels por fo ppeorltyi es as .c cAhl at hr ioduegsh improved l a r g ea vmultitude a the r i e t i rheological e s of o f industrial p o l yproperties s a c cuses, h a r i dof es have in their solutions and of hydrogels, while stillin have a multitude industrial uses, many cases their they biodegradability need to be further maintaining and many cases they need toapplicability be further modified to improve their biocompatibility.

Storage polysaccharides improve applicability ainmodified c r oseeds s s t hto e are w i d emostly s p etheir c t r ustarches m o f e n or da c r o s s t h e w i d e s p e c t r u m o f wide enduses.

In the last few decades, galactomannans, in which the mannan back uses. In chemical the last derivatives few decades, wide ranges of these bone is of built of ß (l→4) linked mannose ranges of chemical derivatives of these polysaccharides were The residues and single unitdeveloped. galactose side polysaccharides were developed.

The chemical modifications improved the chains are attached α (l→6) to all or some chemical modifications improved the rheological properties of The theirextent solutions of the mannose residues.. and rheological properties of their solutions November 2014  45 Pharma Bio World November 2014 45

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and hydrogels, while still maintaining their biodegradability and biocompatibility. pattern of galactosidation on the mannan Storage polysaccharides seeds are backbone varies among plant in varieties. mostly starches or galactomannans, in Nanoparticles which the mannan back bone is built of ßterm (l→4) linked mannose residues The nanoparticle is a collective name and single unit galactose side chains for any colloidal carrier of submicrometer are attached to all or some of dimension andα (l→6) includes nanospheres, the mannose residues.. and nanocapsules, and The extent liposome. pattern of galactosidation the mannan Nanotechnology is gainingonconsiderable backbone in varies among domain. plant varieties . momentum the Pharma The delivering of a pharmaceutically active Nanoparticles molecule to a specific site in the body was adream and it has been a long-held The term nanoparticle is a collective aspiration with beginnings that may be name for any colloidal carrier of traced back to Paul Erhlich, who in the early submicrometer dimension and includes 20 th century coined the phrase “magic bullet” nanospheres, nanocapsules, and to describe such an entity. Drug liposome.

Nanotechnology is delivery gaining systems (DDSs)momentum can improveinseveral crucial considerable the Pharma properties of ‘‘free’’ drugs, such as solubility, domain. in vivo stability, pharmacokinetics, and biodistribution, enhancing their efficacy. The The delivering of a pharmaceutically extensive pharmaceutical research site todayin active molecule to a specific has led to the development of drug delivery the body was adream and it has been systems and strategies, which some way a long-held aspiration withgobeginnings to fulfilling this idea, but few which be that may be traced back to Paulcould Erhlich, described as “magic bullets.”

Side-effects who in the early 20th century coined the and toxicities stillbullet” afflict these approaches phrase “magic to describe such and, hence, Erhlich’s visionary thinking has an entity. Drug delivery systems (DDSs) not yet been fully realized.

This is especially can improve several crucial properties relevant tumour such chemotherapy, wherein of ‘‘free’’in drugs, as solubility, selective deliverypharmacokinetics, to neoplastic cells and in vivo stability, comparison to surrounding cells is biodistribution, enhancingnormal their efficacy. an important principle.

The extensive pharmaceutical research

today has to the development drug There are led many challenges to be offaced delivery systems and strategies, which while delivering the drug from the point goadministration some way totofulfilling this intended idea, but of the specific few which could be described as “magic destination site in the body, in site-specific bullets.”

Side-effects and toxicities still delivery of drugs is immense due to the afflict these approaches and,thehence, numerous obstacles barricading drug Erhlich’s visionary thinking has not yet along its desired route. Cellular structures been fully realized.

This is especially and indeed the very components of the relevant in tumour chemotherapy, where cell itself will either prevent or act in some selective delivery to neoplastic cells selective manner to hinder to the migrationin comparison to surrounding normal cells of drug from its point of administration to is an important principle. the intended destination site. It is obvious that modern medicine still faces many There are many challenges to be faced challenges, till today as we are moving while delivering thecentury. drug from the point forward into the 21st Figure3a-c: 3: Gradual in the the number numberofofScientific Scientificpublications publicationsonona)a)polysaccharides polysaccharides Figure Gradual increase increase in b) b) galactan and c) galactomannan.

Source Scopus scientific web site. galactan and c) galactomannan.

Source Scopus scientific web site.

4612◄ November May 20182014

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specific delivery drugs is immense due which could leadof to significant progress toin thethenumerous obstacles improvement of barricading therapeutic t houtcomes. e d r u g a Instead l o n g i t sofd erelying s i r e d ron o u tthe e.

Cellular structures and indeed the very physicochemical properties of the drug components the cell itself the will drug eitheris to dictate itsofbiodistribution, prevent or act as in asome selective incorporated payload into amanner particle toresulting hinder in to athe migration of mechanism drug from different transit its the intended forpoint theof administration drug after toadministration. destination site. It the is obvious that modernof In particular, development medicine still faces challenges, nanoparticulate drugmany delivery systems till as we are moving maytoday enhance the probability of forward getting a into 21st century. drugthe to its target site. Nanotechnology is the area of research that may offer The nanoparticle should have flexible scientific advances in the future, which nature and several properties which are could lead to significant progress in the incorporated onto the particle, mostly by improvement of therapeutic outcomes. covalent bonding to surface groups. A Instead of relying on the physicochemical targeting system, such as a monoclonal properties of the drug to dictate its antibody, will recognize binding sites that biodistribution, the drug is incorporated are unique to the target cell and allow the as a payload into a particle resulting in particle to dock onto the exposed surface. a different transit mechanism for the Additional target sites on cell surfaces drug after administration. In particular, could be receptor glycoproteins that are the development of nanoparticulate capable of recognizing phosphorylated drug delivery systems may enhance mannooligosaccharide structures (a typical the probability of getting a drug to its example is the Mannose 6-phosphate target site.The nanoparticle should have receptor MPR 300, Mr 300 kDa that flexible nature and several properties is capable of recognizing lysosomal which are incorporated onto the particle, enzymes that contain these structures and mostly by covalent bonding to surface internalize them (Khan et al 2012). For groups. A targeting system, such as successful delivery, carriers must: (i) form a monoclonal antibody, will recognize condensed complexes with biomolecules, binding sites that are unique to the (ii) facilitate penetration of the cell target cell and allow the particle to dock membrane after complexation, and (iii) onto the exposed surface. Additional unload their payloads inside of cells. target sites on cell surfaces could bThe e r e current c e p t o r research g l y c o p r o tine i nthe s t hfields a t a r of e nanoparticles and drug delivery systems capable of recdognizing phosphorylated mare a n nfocusing o o l i g o sinto a c c hdeveloping a r i d e s t rstrategies uctures for targeting nanoparticles the ( a t y p i c a l e x a m p l e i s t h eto M a nsite n o s of e drug action.

A fusion protein will instigate 6-phosphate receptor MPR 300, Mr the kDa process withrecognizing the target 300 that of is merging capable of cell, thereby bringingthat the particle the lysosomal enzymes containinto these cytoplasm.

As polymeric nanoparticles structures and internalize them (Khan et recognized as foreign by thecarriers body’s alare2012).

For successful delivery, immune system, they are removed must: (i) form condensed complexes quite with effectively by (ii) phagocytosis on exposure biomolecules, facilitate penetration of to cell the membrane endoreticularafter system.

This will the complexation, prevent the particle from reaching and (iii) unload their payloads inside the of targetThesite andresearch must be prevented. cells. current in the fields of Steps towardand this goal have systems already nanoparticles drug delivery been taken with the production of soare focusing into developing strategies called “stealth”nanoparticles.

These for targeting nanoparticles to the site of 14 ◄ May 2018 Pharma Bio World

Figure4:4: Applications Applicationsofofnanomaterials nanomaterialsin in biology medicine Figure biology andand medicine are action. nanoparticles drug A fusionwhich proteinincorporate will instigatea biomimetic polymer, usually the process of merging withpolyethylene the target glycol, into bringing their structure cell, thereby the particletointoavoid the elicitation As of polymeric an immune response. cytoplasm. nanoparticles Presently, such as an foreign idealizedbynanoparticle are recognized the body’s with these threethey important properties immune system, are removed quite has yet toby be realized, but attempts effectively phagocytosis on exposure have made to attach some the to the been endoreticular system.

Thisof will subsystems described. prevent the particle from reaching the target site (Loganiaceae) and must be comprises prevented.

Strychnos of Steps toward this goal have about 200 species distributed already in three been taken regions, with the Central production sogeographic and ofSouth called “stealth”nanoparticles.

These America (~73 species), Africa (~75 are nanoparticles which incorporate a species), Asia including Australia and biomimetic polyethylene Polynesia polymer, (about usually ~44 species).

The glycol, into their structure to avoid genus Strychnos is very well known for eits l i cmedicinal i t a t i o n ochemistry f a n i m mand u n ehasr elong s p o nbeen se.

Presently, an idealized nanoparticle studied forsuch its pharmacological, analgesic with these three important properties and antipyretic properties. has yet to be realized, but attempts In recent years polysaccharide nanoparticles have been made to attach some of the are being extensively used in various fields subsystems described. of biology and medicine.

Strychnos seed

material that(Loganiaceae) consists of both Galactomannan, Strychnos comprises of Galactan have.

The role of plant glycosidases about 200 species distributed in three in seeds and in particular to geographic regions, Central reference and South America (~73 species), (~75 a α-mannosidases (their Africa classification, species), including Australia and occurrence,Asia molecular properties and potential Polynesia (about species). The applications need to be~44 explored). genus Strychnos is very well known for Strychnos potatorum Polysaccharides, its medicinal chemistry and has long

Galactomannan Galactan were been studied for and its pharmacological, extracted and have been synthesized analgesic and antipyretic properties.

(Saif et al 2014). These were Icharacterized n r e c e n t y for e a r size s p oand l y s amorphology ccharide

by Atomic Force Microscopy, Scanning nanoparticles are being extensively used Electronic Microscopy, andand Transmission in various fields of biology medicine.

TElectronic h e i m p o r tMicroscopy. a n c e o f t h e Nanoparticles Strychnos from both Galactan and Galactomannan seed material that consists of both were successfullyGalactan preparedhave by been SolGalactomannan, oil chemistry (Saif glycosidases et al 2014). described.

Themethod role of plant in seeds particular to From the and AFMinimages it isreference shown that atheα-mannosidases classification, nanoparticles are(their spherical in shape occurrence, molecular properties for both polysaccharides, and from and the potential applications). images of SEM and TEM we found the size of galactomannan nanoparticles are Strychnos varied from potatorum 45 nm to110Polysaccharides, nm and the size Ga l actoma nnan and Galactan were of Galactan nanoparticles also from 37 nm extracted and used for the nanoparticles to 100 nm, these nanoparticle can possibly preparation.

Thesese were characterized be exploited for many applications such as for size and morphology Drug delivery (Saif et al 2014). by Atomic

Force Microscopy, Scanning Electronic Part of the work financial support Microscopy, andreceived Transmission Electronic from the Department of Biotechnology, Microscopy. Nanoparticles from both GOI, Newand Delhi (Ref.BT/PR6232/ Ga l actan Gal actom annan were BCE/08/402/2005 dt.6-3-2006) successfully prepared by Sol-oil chemistry method.

From the AFM images it is shown References that the nanoparticles are spherical in AdinolfiforM, MM, Lanzetta R, shape bothCorsaro polysaccharides, and from Parrilli M, Folkard G, Grant W, Sutherland the images of SEM and TEM we found the J (1994) Composition nanoparticles of the coagulant size of galactomannan are polysaccharide fraction fromandStrychnos varied from 45 nm to110 nm the size Pharma Bio World November 2014 47

Biomedicine

• Antibacterial creams and powders (Ag) • Gene delivery (CNT) • Biocompatible coatings for implants • Dental composites • Biolabeling and detection (Au, Ag, Quantum dots) • Biosensors (metal oxide, polymer nanoparticles, CNT) • Bone growth promoters (hypoxyapatite ceramics) • Cancer diagnostics and targeted drug delivery (magnetic nanoparticles) • Cell, receptor, antigen, enzyme imaging (Quantum dots) • Fungicides (ZnO, Cu20) • MRI contrast agents (Fe203, Fe304)

Consumer Goods and Personal Care Products

• Anti-bleaching, scratch resistance additives in paints • Anti-scratch coated tiles (alumina) • Barrier packaging (silicates) • Glass coatings for anti-glare, anti-misting mirrors (Ti02) • Skin creams with antioxidant vitamins (nanocapsules) • Sunscreens (ZnO and Ti02) • Water- and stain-repellent textiles • Tennis balls, rackets (nanoclays, carbon nanotubes)

Electronics and Computers

• • • • • • • • •

Chemical mechanical planarization (alumina, silica, ceria) Coatings and joining materials for optical fibers (Si) Conductive coatings/fabrics (rare-earth-doped ceramics) Display technologies (conducting oxides) Ferro-fluids (Fe, FeCo, Fe304) EMI shielding using conducting and magnetic materials Electronic circuits (Cu, Al) Magnetic particles for high-density data storage (Fe) Optoelectronics devices (Gd203, Y 2 0 3 doped with rareearth metals)

Release funds • Anti-scattering layers in photographic film • Molecular sieves to procuring • Conducting/magnetic inks (metal powders) units • Cutting tool bits (A1203, Zr02,WC, TaC) • Chemical sensors • Thermal spray coating techniques (Ti02 , TiC-Co) • Flame retardant polymer formulations (nanoclay) • Lubricants and sealants/hydraulic additives (Cu MoS2) • Pigments (metals and metal oxides) • Polymer composites (nanoclays, Ti02 , Si02) • Spark plugs (metal and ceramic powders) • Wear/abrasion-resistant coatings (alumina, Y-Zr203) Environmental • • • •

Controlled delivery of herbicides and pesticides Self-cleaning glass (Ti02 based coatings) Soil remediation (Fe) Water treatment (photo-catalyst treatments, Ti02)

Food

• • • • •

Flavors and colors in food and beverages (nanocapsules) Frying oil refining catalysis (ceramics) Food pathogen sensing Food packaging materials (nanoclays, Si02, Ti02, Ag) Neutraceutical delivery (liposomes, block copolymer micelles)

Power and Energy

• Anode and cathode materials for solid oxide fuel cells (nanoclays, CNT) • Catalysts for various fuel technologies (metals and metal oxides) • Conducting polymers for bipolar plates in fuel cells • Dye-sensitized solar cells (Ti02 , ZnO, Au) • Thermal control fluids (Cu) • Environmental catalysts (Ti02 , Ce02 as diesel additive) • Fuel cell catalysts (Pt in PEM cells) • Hydrogen storage (metal hydrides) • Improved electrodes in batteries and supercapacitors

Transportation • Automated highways • Battery technology • High strength, light weight composites for increasing fuel efficiency • High temperature sensors • Improved displays • Thermal barrier and wear resistant coatings • Wear-resistant tires

Table 1: 1: Potential PotentialApplications ApplicationsofofNanoparticles Nanoparticles Table 48 16  ◄ November May 2018 2014

potatorum seeds.

Carbohydrate of Galactan nanoparticles alsoResearch, from 37 nm 100 nm, these nanoparticle can be 263:to103-110. used for many applications such as Drug Jayaram K. Murthy IYLN, Lalhruaitluanga delivery (Saif et al 2014).

H, Prasad M.N.V. (2009) Biosorption of lead from aqueous solution by seed powder References of Strychnos potatorum L. Colloids and Surfaces B: Biointerfaces 71, 248–254.

Adinolfi M, Corsaro MM, Lanzetta R, JayaramM, KS (1993) IndianW, tree offers Parrilli Folkard G, Grant Sutherland treatment.ofNature, 365: 779.

Jnuclear (1994)waste Composition the coagulant polysaccharide fraction from Strychnos Khan I and Kumar, N.S, (2012) Mannose potatorum seeds. Carbohydrate Research, 6-phosphate containing nanoparticles: 263: 103-110. preparation, characterization and interaction with cation independent Jayaram K. Murthy IYLN, Lalhruaitluanga mannose 6-phosphate /IGF-II Receptor H, Prasad M.N.V. (2009) Biosorption of (MPR300) J. of Bionanosciences. Vol.5,1lead from aqueous solution by seed powder 9, 2012. of Strychnos potatorum L. Colloids and Puvvada B: GVK, Chandrasekhar K (1997) Surfaces Biointerfaces 71, 248–254 Studies on the metal binding properties of seeds KS of Strychnos potatorum.

NML Jayaram (1993) Indian tree offers technical journal, 39 (4): 239-247. nuclear waste treatment. Nature, 365: 779 Saif M.M.S., Khan I, Prasad M. N. V., Khan I and Kumar, N.S, (2012) Mannose and Kumar N.S, (2014) Preparation and 6-phosphate containing nanoparticles: Characterization of Strychnos potatorum preparation, characterization and L. Seed polysaccharide nanoparticles interaction with cation independent and affinity matrices: relevance to mannose 6-phosphate /IGF-II Receptor biological applications. Advanced Science, (MPR300) J. of Bionanosciences. Vol.5,1Engineering and Medicine 6, 1–8, 2014 9, 2012 Saif M.M.S., Kumar N.S, Prasad M.N.V. (2012) Binding cadmium to Strychnos Puvvada GVK, of Chandrasekhar K (1997) potatorumon the seedmetal proteins aqueous Studies bindingin properties solution: kinetics and relevance of seedsAdsorption of Strychnos potatorum.

NML to water journal, purification, technical 39 (4):Colloids 239-247.Surf. B: Biointerfaces 94, 73-79 Saif M.M.S., Khan I, Prasad M. N. V., and Kumar N.S, (2014) Preparation and Characterization of Strychnos potatorum L. Seed polysaccharide nanoparticles and affinity matrices: relevance to biological applications. Advanced Science, Engineering and Medicine 6, 1–8, 2014 Saif M.M.S., Kumar N.S, Prasad M.N.V. (2012) Binding of cadmium to Strychnos potatorum seed proteins in aqueous solution: Adsorption kinetics and relevance to water purification, Colloids Surf. B: Biointerfaces 94, 73-79

Contact: Contact: prasad.heavymetal@gmail.com prasad.heavymetal@gmail.com Pharma Pharma Bio Bio World World

Pain Point to Gaining Brownie Points: Technology is a Game Changer for Indian Pharma Sector The Indian pharmaceutical industry has come a long way from traditional home-made herbal medicines to being the manufacturer of world class life-saving drugs. However, at the helm of game-changing innovations steering this industry to a whole new level is the implementation of technology.

W

hile providing proper healthcare facilities to the masses in a diverse country like India is a daunting task, it is heartening to note that in spite of challenges, the Indian healthcare industry is constantly moving ahead neck-to-neck alongside the pharmaceutical industry and other allied industries. To support the healthcare needs of a country that has over a billion people, and in helping it realize the vision of universal access to healthcare, the pharma sector forms a major part of the ecosystem.

India has become a crucial destination for manufacture and export of both branded and generic medicines. The Indian pharmaceutical market is projected to cross USD 100 billion by 2025, hence emerging as one of the largest pharmaceutical markets globally. Over the years, the pharma industry in our country has been changing and evolving; but in recent years, with unprecedented thrust on technological advancements and innovation, the pharma sector is growing in a fast track mode.

Overview of Current Challenges of Pharmaceutical Industry in India High Out of Pocket (OOP) expenditure is one of the challenges faced today by the pharma industry or healthcare at large, limiting access to medicines for patients. However, with innovative pharmaceutical products being patented in India, and external pressure from governments and public bodies, the “affordability burden� for this sector is expected to reduce in the near future.

Gauri Angrish Founder & CEO CAREDOSE 18 â—„ May 2018

World Health Organisation informs that more than 50% of people on regular medication do not adhere to their medication. Prescribing medicines to

patients is one thing and making sure patients actually take them is another.

According to standard data, medication non adherence rates can typically range from 30 to 60 per cent. Almost 20 to 80 per cent of patients make errors in taking proper medication and about 20 to 60 per cent stop taking medications when symptoms disappear. What makes the problem of nonadherence even worse is that more than 68 per cent patients do not communicate their non-adherence to their doctors or caregivers.

While this silent epidemic of medical nonadherence needs to be acknowledged and addressed, other major issues we already know about plaguing the industry for a long time include counterfeit medicines, lack of strong IP regulations, and the fragmented structure of the market leading to volatility or non-certainty.

Decoding the Benefits of Tech for the Pharma Industry The recent wave of technological advancements and research, introducing artificial intelligence to cloud computing, is changing the face of pharma industry.

The internet has changed how business operates completely. Today, from online e-commerce platforms selling drugs to online portal on drug information, internet has created empowered patients and/or stakeholders for the pharma sector.

With mobile technology on the rise, sophisticated apps are being developed for disease monitoring, medication adherence support and even health education.

Electronic prescribing (EP) systems not only automate prescribing, but also the supply and administration of medicines from small care unit to hospitals.

At Caredose, for instance, we make use of proprietary tech to track medicine adherence in patients, whilst building Pharma Bio World

big data for healthcare entities and public health programs. We are enabling healthcare entities to manage, track & optimise patient care. This is achieved by partnering up with them and equipping them to track complete medicine adherence in their patients, in real-time.

On the other hand, our service is useful for any individual on regular medication.

With multi-dose dispensers, timely dose reminders, and automated refills, we go

every step to make sure patients take the right medicine at the right time.

Digitization is a boon that not only streamlined the documentation processes but has helped in enhanced record keeping and better security, as well as enhanced safety by eliminating human errors. With automation taking the load of pharmacists, personalized care for every patient no longer remains a distant dream.

“The recent wave of technological advancements and research, introducing artificial intelligence to cloud computing, is changing the face of pharma industry. The internet has changed how business operates completely.�

Pharma Bio World

The Road Ahead This is just the beginning. Technology will perhaps complete change the face of the pharmaceutical industry in the coming decade. Some of the possible scenarios can be the change of pharmacy from drug distribution machines to health consultancies, personalized therapies for patients, and printing out drugs on demand using 3-D printing. Let technology solve the limitation and challenges of the pharma industry today for a healthier India tomorrow.

Contact: shalujha@prandit.com May 2018 â–ş 19

Factors that are Leading to Moderation in Indian Pharmaceutical Industry Export Growth Rate The growth in the domestic pharma market although is expected moderate as compared to past, the sales are expected to improve primarily due to an increase in the penetration of health insurance, improving access to healthcare facilities, rising prevalence of chronic diseases and rising per capita income. The growth rate of Indian Pharmaceutical exports which contributed substantially to margins are expected to taper going forward, the reflection of the same is reported during FY17 and 9MFY18. The factors that are contributing for moderation of such growth are delineated in the article.

Vidhayasagar L Associate Director – Corporate Ratings CARE Ratings Ltd

D Naveen Kumar Senior Manager – Corporate Ratings CARE Ratings Ltd 20 ◄ May 2018

T

he Indian pharmaceutical industry (IPI) holds a strong position in terms of production volumes in the global pharma market as the country contributes around 10 per cent of the world production volumes and share of about 3 per cent of value globally. As per CARE Ratings, IPI has registered revenue of around USD 36 billion in FY17. As per estimates, the industry size is expected to grow at a CAGR of 10 per cent from USD 36 billion in 2017 to USD 48 billion by 2020 given the huge export potential coupled with steady growth in the domestic formulation market.

The Indian pharmaceutical industry is largely dominated by generics drugs as the industry earns around 70 per cent of its revenues from the same. This can also be implied from the fact that India holds 13th position in terms of production value in spite of holding third position in terms of production volume globally.

Lower cost of production coupled by efficient scientific and technical skills of human resources are the prime reasons for growth in exports from India. The growth in the domestic pharma market although is expected moderate as compared to past, the sales are expected to improve primarily due to an increase in the penetration of health insurance, improving access to healthcare facilities, rising prevalence of chronic diseases and rising per capita income. The growth rate of Indian Pharmaceutical exports which contributed substantially to margins are expected to taper going forward, the reflection of the same is reported during FY17 and 9MFY18.

Following are the factors which are impacting the growth trajectory of Indian pharmaceutical industry exports;

1) Reasons for moderation of export sales Out of the total exports by Indian pharmaceutical companies, sales to USA were about one third in FY2016-17 (refers to the period April 1, 2016 to March 31, 2017). USA also provides significant opportunities for generic players across the globe. However, during last decade, the industry has undergone transition resulting in pressure on the profitability margins of the companies for whom exposure to US market is substantial. In this article, CARE Ratings has identified four primary contributors for the decline in margins, viz, (i) consolidation of pharmaceutical distributors in the USA, (ii) mergers among major drug players, (iii) significant increase in Abbreviated New Drug Application (ANDA) approvals and (iv) heightened scrutiny by US Food and Drug Administration (USFDA).

2) Consolidation of distributors in USA

pharmaceutical

About a decade ago, USA had several pharmaceutical distributors with more than 10 distributors contributing to about 80 per cent of the USA’s generic market.

Nevertheless, the last decade has seen a seamless transition which led to consolidation of the distributors and during CY2016 (refers to the period January 01 to December 31), the top four pharmaceutical distributors contributed about 80 per cent of the USA’s generic market share.

The prime intention and driving factor for consolidation of the pharmaceutical distributors is to draw the pricing efficiency from the generic players and extract benefits of economies of scale. The expected benefits derived due to consolidation of the distributors would lead to the savings of anywhere between USD 100 mn and USD 1 bn. While the aforesaid synergies Pharma Bio World

1,526 1,129 901 1,555

1,128

701 FY14

FY17 Domestic (INR billion)

FY20 (E) Export (INR billion)

Indian Pharma Exports and Growth rate 1200 1000

26%

800 600 400

488

635

943

904

15%

17%

13% 4%

FY11

FY12

FY13

FY14 Exports (Rs. Bn)

benefit US pharmaceutical industry, the actual adverse impact would be exerted on generic companies which in turn lead to pricing pressure and thus affecting the EBIDTA margins of Indian pharmaceutical companies. The bigger generic players are likely to sustain the impact to some extent due to larger scale of operations and diversification into other geographies.

However, its impact on the smaller generic players would be felt more acutely. CARE Ratings expects the Indian pharmaceutical companies to witness decline in margins on account of this consolidation deals from FY18 onwards, although simmering of the same has begun since FY17.

3) Merger among major global drug players In order to report robust growth rates, the key strategies deployed by the pharmaceutical companies are Pharma Bio World

838.5

798

200 0

1129

1107

30%

FY15

2% FY16

FY17

35% 30% 25% 20% 15% 10% 5% 0%

9MFY18

Growth Rate

penetrating marketing network, strong brand recall, wide therapeutic coverage and good number of new products in pipe line which require substantial investments in R&D. Consolidation of the global players has led to broadening the therapeutic segments which reduced the risk for these players as they would be capitalising on their existing strengths while netting off their mutual drawbacks. The need to strengthen the the marketing and distribution network also played vital role in consolidation which has led to deeper penetration of the combined entity products thus improving the generated revenue. Consolidation promulgates larger revenue base which helps to support the large R&D budgets required to be spent on developing strong product pipeline.

Furthermore, the combined entity will be deriving benefits from mutual skilled

and experienced human resources along with optimum utilization of the R&D infrastructure to explore on developing innovative durgs for various theraeputic segments. All the above factors culminate in improved economies of scale and efficient utilization of resources while maintaining its operational profit margins amidst competition. Thus the strenghening of India’s counterparts in their home land would inadvertently impact the growth prospects of domestic firms.

4) Increasing trend of ANDA approvals leading to deflationary trend in generic drug prices in US Change in perceptible dynamics of approval process by USFDSA during last five years has boosted competition leading to pricing pressure in the US market in the medium term, especially on plain vanilla products.

USA contributes about 33 per cent of May 2018 â–ş 21

Share of India in total ANDA approvals granted by USFDA

46

1000 800

34

40

36

34

30

50

30

600 846

400 1000 564

200 800

385 34 130

600 0

CY14

400

46

598 34

30

167

CY15 Total approvals

201

36

CY16 Aprrovals to Indian846 Cos

304

112

50

20

40

10

30

0

51

CY17 Q1CY18 Share of Indian Cos (%)20

598 564 on compliance India’s 200 pharma 10 385exports and in this context 201 in CY2016 to 304 in CY2017 and in USFDA’s increasing focus 304 51of cGMP. This restricts the 201 it has increased from of guidelines the pace of granting130 ANDA approvals by167 terms of contribution 112 0 plays vital role. It is observed that 34 to 36 per cent during the said period and manufacturing units to0 supply drugs to the USFDA CY16 CY17 Q1CY18from that facility resulting in US, which is theCY14 major contributor CY15 of the same has increased to 46 per cent during US market Total approvals Aprrovals to Indian Cos Share of Indian Cos (%) generic market has increased its pace of Q1CY2018. The aforesaid demonstrated the decline of revenue for the companies ANDA approvals. The same is expected growth would have adverse bearing on particularly to US market and also from other markets subsequently if the to improve with effective implementation the pricing of generic drug manufactures issues are not closed out. In turn, the of Generic Drug User Fee Amendments thus affecting Indian Pharma players companies, in order to cover their fixed II (GDUFA). The total number of ANDA growth rate. and operational expenses, sell their approvals granted by USFDA during 5)Heightened scrutiny by USFDA products in unregulated markets, rest CY2017 as compared to CY2014 has regulatory authority of world markets and domestic markets increased by 120 per cent. to book revenue for the year where the issuanceletters of the import alerts % shareThe of warning competition is fierce and profit margins Further with implementation of GDUFA, and warning letters for domestic are unattractive. the number of ANDA approvals for Indian manufacturing facilities have increased 88 following As inferred from the above table, the total pharma companies has increased from significantly over the past years number of warning letters issued to Indian % share of78warning letters pharmaceutical companies has increased from 11 during CY2016 to 14 during 88 CY2017.In the current environment of 52 78 pricing pressures faced by the companies on account of increasing competition, developments like these are likely to hamper the profitability margins of the 52 pharmaceutical companies.

11

11

Total

India

Total

2015 Total

India 2015

22 ◄ May 2018

14

11

11

India

Total

2016 Total

India 2016

14

India

2017 Total

India 2017

 vidhya.sagar@careratings.com Pharma Bio World

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Is Telemedicine Sector Ready to Replace Conventional Treatment System in New Digital India?

Digital India is experiencing the rise in the online healthcare segment with major thrust in the growth of Telemedicine.

Telemedicine is envisioned to become a viable model in the healthcare sector for the poor and non-insured people of India.

Even though India has witnessed growth in the last decade, there are challenges which telemedicine service providers are facing related to the cost effectiveness, infrastructure and regulations. There have been a lot of support and many initiatives from the government of India, to help this sector move ahead.

Even though rural India is still grappling with poor infrastructure and healthcare facilities, urban India has a huge potential and expect exponential growth of telemedicine in the coming years

Dr Subroto Ghoshal, PhD Senior Manager- Human Resources Mindteck 24 ◄ May 2018

I

n India, healthcare system has become one of the largest service sector in the country. According to FICCI report, this sector is emerging as the most progressive service sector in the country.

It is anticipated that after information technology industry, healthcare sector will be the next big thing in India. Healthcare system covers hospital, medical devices, telemedicine, medical equipment, clinical trials and health insurance. The Indian healthcare industry has been seeing growth in the past few years. The population in India above 60 years which was estimated at 96 million in 2010 is expected to grow to around 193 million. Apart from this, Indian consumers are not just looking at proper healthcare but also for the services that can be personalized. These are some of the factors that is contributing to the growth of healthcare segment of India.

With exponential growth in the demand for healthcare services and the challenges experienced in gap which exists in offline healthcare, digital healthcare services evolved in bridging the gap. Online healthcare has the advantage and flexibility to meet the growing demand and handling the requirement for quality and better services.

The base for the concept of telemedicine is the easy access to remote areas and to bring down the time and cost of patient for the doctor consultation. The utility of telemedicine depends on the usage of technology to improve the communication between the doctor and patient who are separated by distance, providing e-medical records, ambulatory monitoring etc. “Telemedicine work best when the diagnosis is straight forward and the treatment is routine. It is fast and easy and the most important factor is the chances of spreading the infection from patient to medical personnel is reduced” avers Dr. Sriram Nathan, ENT Surgeon at Narayana

Health Multi-specialty hospital, Bangalore.

India faces challenge when it comes to relocate a doctor from urban to rural or suburban areas and therefore these areas are getting deprived of doctors. Under this situation, telemedicine will become a boon for the entire Indian population who can have easy access to any specialty doctor by using telecommunication and satellitebased technology.

History of Telemedicine It is assumed that telemedicine has grown in the last 5 to 6 years but the truth is that this concept had been implemented around thirty years ago. The National Aeronautics and Space Administration (NASA) used this concept in the development of telemedicine when humans began flying in space. NASA developed the system where physiological parameters were transmitted from space craft and from the space suits during mission. “One of the earliest endeavors in telemedicine, Space Technology Applied to Rural Papago Advanced Health Care (STARPAHC) delivered medical care to Papago Indian reservation in Arizona. It ran from 1972 – 1975 and was conceived by the NASA” as quoted in the article published in ncbi.nlm.nih.gov.

In India, telemedicine has been existing over two decades now. The foundation on which online health or telemedicine works is the usage of telecommunication and information technology. The principle of telemedicine is to overcome distance barrier and reduce the time of waiting for clinical healthcare for individuals. In India, government, private hospitals and NGOs are trying to join hands to manage synergies in order to provide quality healthcare with the support of telemedicine for the population across the country.

‘Union ministry of health signed a memorandum of understanding (MOU) with Indian Space Research Organisation Pharma Bio World

790

750

$800 $700 $600 $500 $400 $300

386

439

294

277

$200 $100 $0 Wearables

Data Analytics

Wellness

Telemedicine

mHealth apps

Appointment booking

Source: Mercon capital group Figure 1: Funding in technology area in 2015 (USD million) (ISRO) to expand its telemedicine network to remote places.’ In 2000, India’s telemedicine centre at Apollo Aragonda hospital in Andhra Pradesh was inaugurated by the US president Bill Clinton. Today we have more than 500 centers linked with multiple specialty hospitals.

India Online Healthcare Market According to Deloitte Touche Tohmatsu India it is estimated that Indian healthcare market is around USD 100 billion. It is expected that it will grow at 23 per cent CAGR to reach USD 280 billion by 2020. As per the study of Assochem, this market is estimated at over USD 15 million and has the potential to grow above USD 32 million by 2020.

In India, online healthcare particularly in the sector of telemedicine, there has been active support from the department of Information and Technology (DIT), Indian Space Research Organisation (ISRO), NEC Telemedicine program for northeastern state, Apollo hospital and state government.

Department of Information and Technology has the focus on long term objectives and provides assistance and guidance in the initiation of new schemes, standardization and framework for building the infrastructure Pharma Bio World

of information technology in the sector of healthcare. There has been immense contribution by the center for development of advance computing, C-DAC in developing telemedicine software which support telecardiology, tele-radiology, tele-pathology etc. They have used technology to connect the three premier medical institute of the country viz. All India Institute of Medical Sciences (AIMS), New Delhi, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow, and Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.

Telemedicine services have been focusing on the various healthcare segments like radiology, consultations, ophthalmology, dermatology, pathology, psychiatry etc.

In Karnataka, telemedicine network project was initiated in 2001 in collaboration with Indian Space Research Organisation (ISRO) and the department of health and family welfare, government of Karnataka.

In Bangalore National Institute of Mental Health and Neuro Science (NIMHANS) provides neurosciences specialty services, Sri Jaydeva Institute of Cardiology provides services related to cardiology, Kidwai Memorial Institute of Oncology caters to

oncology while general healthcare services are supported by the Bowring and Lady Curzon hospital.

Initiative by Government As per the report published in ibef.org under healthcare India, government of India is taking a lot of initiative to develop the Indian healthcare industry. As per the source of information collected ‘India is initiating first ever Air Dispensary, helicopter based dispensary. It will be launched in the northeast and the ministry of development of northeast region has already contributed ` 25 crores (USD 3.28 million) for its funding.

The Intensified Mission Indradhanush (IMI) has been launched by the government of India to provide immunization across the country and to reach children below two years of age and to pregnant women.

Ministry of health and family welfare is targeting to cross more than their allocated budget of ` 955 crores (USD 148.22 million) to manage the diseases like diabetes, obesity and cardiovascular disease in India.

The union cabinet approved setting up of National Nutrition Mission (NNM) with a three year budget of ` 9046.17 crores (USD 1.40 billion) to monitor, supervise and guide May 2018 ► 25

the nutrition related interventions across the ministries. The government of India aim to increase total health expenditure to 2.5 per cent of Gross Domestic Product (GDP) by 2025 from the current 1.15 per cent’.

Statutory Regulations in Telemedicine Telemedicine has an advantage to connect doctors and the patients from different locations. In a situation like this, it is very important to have a specific regulation by the government authority to regulate telemedicine. Unfortunately, there is no defined law to govern telemedicine. Today this sector uses scattered regulations like Information Technology Act- 2000, Drug and Cosmetics Act- 1940, The Indian Medical Council Act-1956 and the Clinical Establishments (Registration & Regulation) Act – 2010. CERRA governs all clinical

medicine, connect them with doctor or chemist. There is DocApp technology solution to support patient engagement and appointment.

Hyderabad based Doconline started its journey in November 2016. This company provides unlimited online doctor consultation to subscribers and his family members by connecting the patients to the medical experts. The feature of this service provider is consultation through audio, video and chat mode with the medical practioners in the preferred language of the patient, get prescription and view all medical records using online healthcare platform. Doconline provides consultation solution using Android, iOS and web based technology platform. Rahul Paith, COO of Doconline says “We have around 25,000 corporate subscribers and around 100,000

“Unfortunately, there is no defined law to govern telemedicine.

Today this sector uses scattered regulations like Information Technology Act- 2000, Drug and Cosmetics Act- 1940, The Indian Medical Council Act-1956 and the Clinical Establishments (Registration & Regulation) Act – 2010. establishments. Though the definition of clinical establishments is broad and does cover the services provided by telemedicine but there seems to be lack of clarity. The liability of the doctors or the paramedics who fall under the segment of telemedicine is yet to be clarified. The lacunae which exits in the regulation of the telemedicine services is questioning the viability of this model of healthcare.

Contribution by Startups India is experiencing the high growth of startup in India who are contributing in the digital healthcare space and carving out the online healthcare landscape. In the last decade, India has been witnessing the enhancement in the preventive healthcare and monitoring solution, medical devices, clinical trials, outsourcing, telemedicine, medical tourism, health insurance and 26 ◄ May 2018

medical equipment. Today smart phones are providing one stop solution to access a doctor, hospital or a diagnostic center.

As per the report published in 2016 under digital health startups, out of many healthtech startups who are contributing in this segment are Medikabazar, Medibox Technologies, eKincare, Rxpress, Doconline health and Thrymr software. Startups like Practo, Protea medical, Med Genome, Lybrate, Medwell ventures have already established themselves in the online healthcare segment. There are healthcare service providers who provide business to business or business to consumer solution for all hospitals, medical institution suppliers and home health medical devices and aids. There are comprehensive medical apps which provides services like buying medicines, uploading prescriptions, doctor consultation, reminding patients to take

lives impacted altogether. Hyderabad is the India head quarter and we have fully operating satellite office in Pune. We are planning to expand to another 2 to 4 states by 2018.”

The company is focused to provide online consultation with doctors, in-house doctor service in the corporates, facilitate customer to order medicine through app, discount in its network hospitals and diagnostic centers.

Doconline caters to the preventive care and not for the emergencies.

As per the report published in The Telegraph News paper, 21 Februrary 2018, Kolkata, a UK based doctor is planning to set up digital dispensary to treat the patients through telemedicine in West Bengal. Their aim is to provide quick primary check up in the rural areas so that the treatment is not delayed as there is shortage of doctors in these areas. It is indicated that Agile Health care and Rehabilitation Service has collaborated with a city based health care service to offer telemedicine service.

Five centers are operating in Bihar and 65 new locations are planned in the country.

As informed, the capital expenditure per center will be ` 25 lakhs and the patients will be charged ` 200 for consultation and medicines. They will also provide tests at 50 per cent cost and electronic medical records will be maintained. the mode of treatment would be carried out through video images. The treatment would focus on common condition and ailments and for any further or advance treatment, patients would be referred to hospitals.

Challenges in Telemedicine Sector Even though telemedicine is booming in the Indian healthcare segment, there are still many hurdles which needs to be overcome to make telemedicine an integral part of India’s healthcare segment. One of the challenges which needs to be confronted is the cost effectiveness of the technological equipment and manpower cost. It is also experienced that many doctors are not fully convinced with the concept of telemedicine.

Many doctors cited that they prefer to see the patient for better diagnosis.

Pharma Bio World

“At present there are many unresolved legal and ethical concerns regarding telemedicine technology which restricts many doctors to venture into this mode of treatment.”

Dr. Sriram Nathan, ENT surgeon at Narayana health multi specialty hospital, Bangalore opines “telemedicine is still not suitable for emergency. It has robotic approach with less empathy towards the patient. Nothing can replace the direct visualization of the patient by the doctor”.

There are many patients who are also not convinced with the idea of treatment over phone. As per the data, only 65.38 per cent of India’s population is literate and around 2 per cent well versed in English. This becomes a bottleneck to make telemedicine an integral part of healthcare all across the country. In the current scenario, 40 per cent of population lives below poverty level.

They are deprived of many basic needs and services. In a country with such high percentage of people under poverty level, making telemedicine successful is a big challenge. Even though the government is trying to give a push, it has its own limitations. Initiative has to be taken by building public private participation.

At present there are many unresolved legal and ethical concerns regarding telemedicine technology which restricts many doctors to venture into this mode of treatment. Since telemedicine services are mainly concentrated in the urban India, there is a need to do a lot to extend the services to the rural India. Telemedicine is still best suited for general consulting and their role in critical care still needs to be evaluated.

Conclusion Telemedicine is trying to bring a paradigm shift in the healthcare system of India.

The focus is on how to provide both basic and critical care under this umbrella but success depends on the ultimate challenge in removing the obstacles which have been mentioned earlier. The government needs to Pharma Bio World

build up more public private collaboration to make it successful at national level.

There is a need to have standardized training program which will support the entire process of telemedicine service for all providers. The planning commission has made suggestion in the 12 th five year plan period for using telemedicine solutions. There has to be a focus to raise the doctor’s willingness on the utility of this along with the technical training for the staff who work with these providers.

Connecting urban with rural India in terms of hospitals, equipment availability with doctors, specialized telemedicine units, synchronization with ICU, emergency & trauma care and providing transport system to mobilise critical patients. As of now there is no dedicated e-health law in India and therefore there is a risk of medical e-commerce providers to ignore Indian law.

There also exists a risk of medical legal and technical legal issue which comes as a barrier for some doctors from entering this segment. On a macro level there is a need to increase the awareness at the national level, educating the population particularly in the rural area and providing cost effective centers to harness the vision of digital India.

5. Economictimes.indiatimes.com/ wealth/spend/online-medicaladvice-comes-at-low-cost 6. F o r b e s . c o m / krnkashyap/2017/09/25/howstartups-are-trying-to-overcomeindias-healthcare-challenges 7. Healted.com/blog/telemedicinein-india 8. Hindustantimes.com/india-news/ with-105-centres-govt-spreadtelemedicine 9. Iamwire.com/2015/06/trendschallenges-and-opportunities-inonline-healthcare-ecosystem 10. Ibef.org/industry/healthcare-india 11. Kenresearch.com/healthcare/ general-healthcare/india-online 12. Livemint.com/politics/healthcaredigital-adoption 13. Ncbi.nlm.gov/pmc2782224.

14. N c b i . n l m . n i h . g o v / pubmed/19659413 15. Quora.com/what-is-best-onlinedoctor-consultation-portal-in-india 16. Tele-clinics for basic care; The Telegraph, Kolkata, 21 February 2018 17. Y o s t a r t u p s . c o m / 1 0 0 1 startup-ideas-online-doctorsconsultation-platform

Reference 1. Business-standard.com/content/ b2b-pharma/indian-telemedicinemarket 2. Businesstoday.in/magazines/ features/indian-health-caremarket-is-giving-new-opportunityfor-tech-startups 3. D a z e i n f o . c o m / 2 0 1 6 / 0 9 / 1 0 / changing-landscape-onlinehealthcare 4. Digitaljournal.com/life/health/ growth-in-online-medicalinformation

Contact: subrotogh@yahoo.com May 2018 ► 27

Alex Alcala President, CRANE ChemPharma & Energy Andrew Powell Vice President / General Manager, CRANE ChemPharma & Energy Hari Jinaga MD and India President, CRANE ChemPharma & Energy

Advancements in valve industry have enabled manufacturers in the pharmaceutical industry to improve their manufacturing capabilities through maximising uptime, reducing overall cost of equipment ownership, and lowering maintenance costs.

These benefits extend throughout the value chain in the form of financial returns and increased maintenance resources, all of which result in better patient care.

Alex Alcala, President; Andrew Powell - Vice President / General Manager; and Hari Jinaga, MD and India President, CRANE ChemPharma in an interaction with Pharma Bio World elucidates technologies and trends in the valve industry and how can these developments favorably impact operational performance in the pharmaceutical manufacturing industry.

28 ◄ May 2018

“Satara Plant will allow us to expand service offering in India, while strengthening our commitment to local manufacturing and support” Please do give our readers a brief picture of your group’s product portfolio and the markets you serve?

Crane ChemPharma & Energy designs and manufacturers a comprehensive portfolio of highly-engineered valves, actuators, lined pipe, fittings, hoses, air operated diaphragms and peristaltic pumps, enabling us to provide the right product for the right application. Our products are capable of serving the most demanding corrosive, erosive and high-purity applications across the chemical, biopharm, power, oil & gas and refining industries. Specifically, within the biopharm industry, the new Satara site of Crane India will be a key source of our local Saunders ® HC4 products.

The Saunders ® HC4 Aseptic product range incorporates a wide platform of forged twoway, standard and custom machined block body solutions, actuators and sensors designed to meet increasing demands for hygienic performance and regulatory compliance in Life Science process and utility applications.

What are your views on the global industrial valves market and the policy & regulatory landscape of the industry in India?

The Pharmaceutical industry has been a catalyst for change in terms of drug discovery and development. The introduction of new

medicines, vaccines and medical tools, coupled with the tightening of global standards is revolutionizing the industry and improving the quality of life for many patients around the world. That’s why it’s important that the quality of pharmaceutical manufacturing be beyond reproach, as mistakes and problems have the potential to impact life. Through initiatives like PAT (Process Analytical Technology) and QbD (Quality by Design), we’ve seen a keener focus on quality improvement and the incorporation of smart equipment by pharma manufacturers, enabling such benefits as data acquisition over an industrial network.

The diaphragm valve industry is one that has experienced a major shift toward smart technology in the creation of new accessories that, in conjunction with aseptic valves, offer unparalleled control, resulting in a solid and reliable manufacturing process.

Innovation has been the recurring theme in your approach towards market. What are the most significant innovations or the unique strategies your business has brought into the market? Especially in India.

Saunders® was founded on the bases of innovation when P.K. Saunders invented the first diaphragm valve in 1929. Since then, we have remained a key player in the evolution of high purity valve technology.

To answer the call for smart components, we have developed a suite of automation products called the SaundersVUE that adds intelligence to a diaphragm valve, offering Pharma Bio World

Crane Welcomes Over 300 Industry Stakeholders to New Aspetic Valve Factory in Satara for Day-Long Inaugruarion Event On May 10 over 300 industry professionals including Customers and Distributors, attended the inauguration ceremony of the new Crane Saunders Aseptic Valves factory in Satara, India, hosted by Crane Process Flow Technologies India Private Limited and ChemPharma & Energy, Saunders®, businesses of Crane Co. This day-long event included a luncheon and tour of the new plant that is completely dedicated to Saunders® HC4 products. The factory was inaugurated by Mr. Andrew Powell, the VPGM of Saunders, in presence of Mr. Hari Jinaga, President of Crane India, Mr. Alex

Alcala, President of Crane CP&E, and Mr. Mark Youssef, the President of Crane MEA. “Crane has maintained operations in India for over 25 years and it’s important to us that we continue to invest in the community and increase the ways in which we provide local support,” said Hari Jinaga, President, Crane India. “The facilities that have been built here in Satara are best-in-class; we’ve installed state of the art machines and software and set up world-class fabrication cells to ensure our products maintain the quality Crane is known for.”

Some of the new features and capabilities of the new site include: • State of the art 5-Axis CNC Machining Centers providing full capability to produce multi-weir block valve technology • A new Inspection Station where surface roughness, dimensional and borescopy controls ensure adherence to global standards

Pharma Bio World

• A new Fabrication Cell using both automated (Orbital) and manual (TIG) certified welding processes, WPS (Welding Procedure Specification ) and PQR (Procedure Qualification Record), as well as ASME Section 9 Qualified Welders • Washing & Laser Marking cells for better cleaning capabilities and permanent serial valve marking for lifelong traceability of every valve • Separate Assembly cells for 2-way valve assembly and block valve assembly in a controlled atmosphere to ensure maximum cleanliness during production

• Foam Packing cell with advanced machinery to ensure consistent and quality packing and eliminate transit damage to the product • Material Replenishment System for improved parts inventory management further supporting the reduction of lead times for all aseptic valve products Earlier that same day, the guests joined Mr. Jinaga, as well as Alex Alcala and Mark Youssef, among other members of the company’s leadership, for a groundbreaking ceremony of the Crane-sponsored Maher Home for Disadvantaged Children.

“In partnership with local NGO Maher, Crane is pleased to be a part of this initiative through the purchase support of the land and construction of the hostel at Satara that will become a safe-haven for 50 local children,” said Hari Jinaga.

new possibilities to our customers in the Life Sciences industry. Designed on a platform that maximizes plant efficiency by eliminating false alarms and reducing set up times, SaundersVUE valve sensors are designed to provide positive and accurate confirmation of diaphragm valve positioning, while delivering diagnostics for continuous monitoring and preventive maintenance. The suite consists of the Saunders I-VUE intelligent valve sensor, and the more compact Saunders M-VUE that offers one-step contactless valve and sensor calibration in 3 minutes. Both have their own features that make them applicable for various applications.

CRANE ChemPharma Flow Solutions is inaugurating the new aseptic diaphragm valve factory in Satara. Tell us more about this endeavor and how will this move put company in a stronger position in the market?

The new factory in Satara will be 100 per cent dedicated to Saunders ® HC4 aseptic diaphragm valves and actuators. It is an incredibly important move for Crane because it will allow us to expand our service offering in India, while strengthening our commitment to local manufacturing and support. The facilities that have been built are best-in-class, we’ve installed state of the art machines and software and set up world-class fabrication cells to ensure our products maintain the quality Crane is known for.

We know CRANE ChemPharma Flow Solutions continues to evolve.

What are the main strategies you adopted to maintain company’s current position in the Indian valves market?

Since 2015, Crane ChemPharma & Energy has invested more than USD 6 Million in India.

We have established local manufacturing locations for several key products, including the Duo-Chek and our complete range of butterfly valves which includes Resilient May 2018 ► 29

Seated up to 48 inches and the Flowseal HPBV up to 24 inches. We’ve also transferred the IDV product center to this market and are now opening this world-class HC4 aseptic valves factory.

What in your opinion are the major factors responsible for the growth penetration of the aseptic valves market in India?

It definitely comes down to the quality and range of our offering and the ability to meet or exceed customer lead times. It’s an incredibly important aspect of our industry and by establishing a local manufacturing and support system, we are better positioned to ensure faster delivery, quick response and knowledgeable local technical assistance here in India.

What would you consider the most relevant issues which need to be discussed in the aseptic valves market at the moment? How do you think the markets are responding to this new structure?

As mentioned earlier, the newer technologies available today have paved the way for intelligent sensing, automation and smart technology to be used in the aseptic valve space. Developing these products while maintaining safety and fugitive emissions standards is key. Present in every fluid processing application, the impact of fugitive emissions on the environment is a global issue and regulatory agencies are placing significant focus on reducing them, and with good reason. It’s important that customers and manufacturers work together to ensure the right products are being used for the right application to minimize emissions as much as possible.

portfolio that is recognized for quality and reliability. We’ve been in business for over 160 years and we have many trusted brands and products, some that have been in operation for more than 70 years. We are a company that has been here and will continue to be for years to come, and our customers can be confident that when they partner with Crane, they are doing so with a company that has a global presence but a local mindset, building a strong network of application expertise, local inventory and specialized support.

Finally, what can your markets expect in the future from CRANE ChemPharma Flow Solutions?

Crane strives to make continuous investments in strategically important regions like India, and it’s something that we as a whole will continue to do globally. Furthermore, Crane Co. is a stable business with a strong brand

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30 ◄ May 2018

Pharma Bio World

Market Research

3QFY18 Results Preview: Still Not Out of the Woods       

Pharma Bio World

%YoY Growth - RHS

15.0

370.0

10.0

360.0

350.0

5.0

340.0

-

330.0

320.0

-5.0

310.0

4QFY18E

3QFY18E

2QFY18

1QFY18

2QFY17

4QFY17

-10.0

3QFY17

300.0

Overall EBITDA Margin To Remain Steady EBITDA (Rs bn)

Margin (%) - RHS

100.0

30.0

80.0

25.0 20.0

60.0

15.0

40.0

10.0

20.0

5.0

4QFY18E

3QFY18E

2QFY18

1QFY18

-

4QFY17

-

3QFY17

EBITDA over QoQ. The performance of both stic/CRAMS/divercified model: We believe that these players will be plagued by lingering differentiated business models like CRAMs (DIVI regulatory issues, vulnerable US product sified business mixes (GRAN, JUBILANT and STR) structures d numbers in portfolio 4QFY18and as increased well. Wecost expect (1) for specialty/complex generic molecules.

LANT’s pharma business, (2) better profitability in ALPM’s performance is businesses, likely to be hit(3)by e off cost and improved regulatory the pricing negative inoperating leverage dueforto nsion and better select molecules ood quarters for DIVI, DCAL and NLL. On YoY, all of underutilized new capacities. these companies will fare better as 4QFY17 CAL, NLL was hit by severe price erosion in the US.

Revenues (Rs bn)

380.0

2QFY17

elusive for many US focused companies: With Strong revenue growth elusive niche products like gRenvela and gLialda, DRRD, for many US focused companies see their US business revenues normalizing and n sequentially.With While SUNP and LPC will indeliver increased competition niche Q. The performance these players be productsof both like gRenvela and will gLialda, atory issues, vulnerable US product portfolio and DRRD, CDH, ARBP and CIPLA to see their for specialty/complex generic molecules. ALPM’s US business revenues normalizing and e hit by the negative operating leverage due to profitability to come down sequentially. es. On YoY, all of these companies will fare better SUNP re price erosionWhile in the US.and LPC will deliver improved

Expect ~3% YoY Rev Increase For Our Coverage Universe

1QFY17

f the woods

absence of one off cost and improved regulatory businesses, (3) benefits of capacity expansion and better pricing We believe that pharma companies having in select molecules for GRAN and (4) differentiated business models like CRAMs seasonally good quarters for DIVI, DCAL (DIVI and DCAL) or highly diversified and NLL. PHARMACEUTICALS : 4QFY18E RESULTS PREVIEW business mixes (GRAN, JUBILANT and STR) are likely to report good numbers in Top picks: CDH, ALKEM, DCAL, NLL 4QFY18 as well. We expect (1) improved traction in JUBILANT’s pharma business, (2) better profitability in STR due to Continue to prefer domestic/ CRAMS/divercified model

1QFY17

A

fter reporting two better quarters, we expect the top line for our pharmaceutical coverage universe to decline 2-3% QoQ while EBITDA margin is likely to remain steady at 21% in 4QFY18. Within the sector, considering the seasonality in the business, only CRAMS companies are likely to report sequential improvement. Most of the US focused formulation companies will report single digit decline in the top line and earnings are likely to be better ter quarters, we expect the top line for our sequentially due to low base of 3QFY18 universe to decline 2-3% QoQ while EBITDA (hit by US tax adjustments). Although n steady at 21% in 4QFY18. Within the sector, YoY performance appears much better ty in the business, only CRAMS companies are (Revenues EBITDA tial improvement.

Most– Up of 3%YoY the USandfocused 170bpsinYoY), ill report singleMargin digit up decline the structural top line issues and like due unfavorable pricing environment, etter sequentially to low US base of 3QFY18 (hit pending plantappears clearances low Although YoY performance muchand better and EBITDA Margin up 170bps YoY), structural visibility on the lucrative approvals are S pricing environment, pending clearances still dominating.

We plant continue to believe e lucrative approvals aregeneric still dominating. that the US businesses areWe not he US generic completely businessesoutare not completely out of the woods and will need d more time to more recover. time to recover.

Source: Company, HDFC sec Inst Research

2 May 2018 ► 31

Market Research COMPANY

4QFY18E OUTLOOK

WHAT’S LIKELY

KEY MONITORABLES

AVG

• The top-line is likely to decline 5%YoY and flat QoQ with no big ticket • FY19E generic launch launches in the US market over last one year. Domesticbusiness will grow guidance at market rate.

• Updates on Halol facility • Sequential improvement of EBITDA margin to continue as spend on the • Specialty pipeline progress specialty part of the US business is stabilizing.

AVG

• With higher competition in gRenvela and lack of traction in recently • Commentary on the launch launched Pulmicort respules, CIPLA’s revenues will be up only 8%YoY of further limited competition and down 1.3% QoQ in 4QFY18. This too is largely aided by domestic opportunities in the US and RoW market growth.

• Clarity on recent US FDA inspections in Goa and Indore • EBITDA margin will contract to ~20% (down 60bps QoQ) owing to the increase price erosion in key products like gRenvela. facilities

GOOD

• CDH to post another bumper quarter with limited competition product like gLialda and gTamiflu in the US. However, top line will decline sequentially • Guidance on other significant approvals such as transdermals as higher channel filling is likely to have happen in 3QFY18. Ex-US, all other businesses are likely maintain their growth trajectory. and Asacol HD • EBITDA margin at 23.7% will be up 388bps YoY and down 215bps QoQ

AVG

• With no incremental competition in gFortamet and gGlumetza, and • Visibility on significant product absence of one off costs, LPC to report improved operational performance launches in the US market in in 4QFY18.

FY19 • Top line may decline 11%YoY and 4%QoQ but EBITDA margin will be • Commentary on price erosion in up~100bps YoY and 200bps QoQ to 19.3% gGlumetza and gFor

Dr Reddy’s Labs BAD

• Update on regulatory matters • With gRenvela and gToprol XL revenues to go down in 4QFY18 due to (Duuvada, Medak) new entrants, top line is likely to decline 6%QoQ . We expect US$ 240mn • Base business erosion. sales from the US market v/s US$ 247mn in 3QFY18.

• Visibility on key product launches • EBITDA margin is likely to be at ~19.6% for the quarter, up ~320bps YoY like gSuboxone, gCopaxone, but down ~60bps Qo gNuvaring.

Sun Pharma

Cipla

Cadila Healthcare

Lupin

Aurobindo Pharma

Divi’s Labs

Alkem Labs

32 ◄ May 2018

AVG

• Similar to DRRD and CIPLA, ABRP is also likely to witness drop in the • Guidance on complex product US top line due to lower sales from gRenvela. Expect overall revenues to approvals in FY19 decline 5%QoQ and grow 14%YoY. • Base business growth in the US • With low gRenvela sales and higher R&D spend, expect margins to market decline 100bps.

• Capex and debt reduction plan

GOOD

• Recovery in the business post • With the import alert being lifted in Nov-17 and 4Q traditionally stronger for import alert lifting DIVI, we foresee ~10% QoQ growth in the top-line and a pick-up in margins • Pending Unit 1 inspection to ~34.7%, up ~180bps QoQ. • Commentary on capacity • Comparisons on YoY basis would not be appropriate due to the regulatory expansion disruptions to the business in FY18.

BAD

• 4Q has always been seasonally weak quarter for ALKEM in the past, largely due to lower acute product sales and early book closure. Expect top line to decline 19% QoQ and grow ~13%YoY in 4QFY18. EBITDA margin to post • Commentary on US business 70bps YoY contraction at 11.2%. ramp-up from 2HFY18 • We have cut our target PE multiple from 25x to 20x after it received thirteen 483 • Clarity on recent US FDA observations for Daman formulation facility. We believe these observations inspections at Daman plan are serious in nature and could delay ANDA approvals over next 6-8 months.

• Revise TP: Rs 2,124, Rating: BUY

Pharma Bio World

Market Research COMPANY

Torrent Pharma

Glenmark

Jubilant Life Sciences

4QFY18E OUTLOOK

WHAT’S LIKELY

KEY MONITORABLES

GOOD

• Integration of Unichem’s India brands (from mid Dec-17) will provide an • Pick-up in filings for the US optical boost to top-line growth for TRP, It is likely to grow at 20%YoY and market 16%QoQ in 4QFY18.

• Timeline for launches of in• Expect EBITDA margin to be at ~24% (up 344bps YoY, down 26bps QoQ) hand products in the US market in 4QFY18E as the business mix normalizes.

SVG

• Progress on debt reduction • With the base of gZetia launch under 180-days exclusivity in 4QFY17, • Guidance on pick-up in US GNP is likely to post a ~15% YoY top-line decline in 4QFY18. launches • EBITDA margin is likely to contract ~427bps YoY, but improve • Progress of novel pipeline ~280bps sequentially (due to better business mix) products and any out-licensing arrangements

GOOD

• Integration of Triad and continued traction in the specialty chemicals • Progress in radio pharma business should see the top-line growing 22.5% YoY. business, especially Ruby-Fill • Although we expect pricing tailwinds in the specialty chemicals business • Long-term outlook on specialty to settle down in 4QFY18, improved traction in speciality business could chemicals business lead to better EBITDA margin sequentially (20-25bps)

Alembic Pharma BAD

• With the absence of new product approvals for the US market and steady growth in other segments we expect ALPM top line to grow at • Guidance on growth revival in the 6%YoY and decline 6%QoQ. • EBITDA margin to decline 180bps sequentially with more capacities US business being commissioned in 4QFY18 and production activities are yet to start. (230bps YoY improvement is largely on account of a low base)

Strides Shasun

• Expect STR to continue the sequential improvement in its operational performance aided by better traction in the US and Australia and absence • Visibility on further niche product of one off promotional cost for the consumer business. filings / launches in the US • Top line to grow 3% and EBITDA margins to improve 30bps QoQ in • Progress in the Australia business 4QFY18. YoY performance is not comparable due to divestment of India and launch guidance and API businesses.

GOOD

Dishman Carbogen Amcis GOOD

Granules India

Neuland Labs

Pharma Bio World

• Foresee ~10%YoY decline in top line on a high base of 4QFY17.

• Guidance/visibility on further Sequentially we would see 5% jump as 4Q is seasonally strong commercial launches quarter for the CRAMS companies.

• Growth outlook on Vitamin D • Higher contribution from Carbogen entity is likely to keep EBITDA business margin flat sequentially.

GOOD

• Revenue to grow at 17% YoY, with fresh API and PFI capacities • Update on ANDA filings. getting commissioned.

• Commentary on US formulations • EBITDA margin will be impacted by higher raw material cost. Expect launches 350bps YoY margin erosion .

AVG

• Revenue to grow 19%QoQ and decline 4% YoY in 4QFY18. Higher Cipro sales are likely to help NLL to deliver sequential growth.

• FY19 guidance • EBITDA margin is likely to remain subdued due to negative operating • Progress in various CMS projects leverage (low capacity utilization

May 2018 ► 33

PHARMACEUTICALS : 4QFY18E RESULTS PREVIEW

Market Research

Financial Summary

 

NET SALES (Rs bn) 4Q QoQ YoY FY18E (%) (%) 67.8 1.8 (5.1) 38.6 (1.3) 7.9 30.7 (5.7) 24.0 38.0 (4.4) (10.6) 35.9 (5.7) 1.0 41.0 (5.5) 13.8 11.4 9.6 6.7 14.1 (19.0) 12.7 17.2 16.2 19.7 20.6 (5.1) (15.0) 19.6 (5.3) 22.5 7.8 (6.6) 6.3 7.7 3.1 (13.0) 4.8 4.8 (9.8) 4.1 0.7 16.5 1.4 19.1 (3.6) 360.7 (2.5) 2.9

Company Sun Pharma Cipla Cadila Healthcare Lupin Dr. Reddy's Labs Aurobindo Pharma Divi's Labs Alkem Labs Torrent Pharma Glenmark Pharma Jubilant Life Sciences Alembic Pharma Strides Shasun Dishman Carbogen Granules India Neuland Labs Aggregate

EBITDA (Rs bn) 4Q QoQ YoY FY18E (%) (%) 15.4 6.1 (0.3) 7.8 (4.2) 54.9 7.3 (13.6) 48.3 7.3 6.7 (6.0) 7.0 (8.4) 20.7 9.3 (9.4) 28.8 4.0 15.5 1.1 1.6 (56.0) 5.9 4.1 14.8 39.7 3.3 14.8 (32.8) 4.0 (4.3) 30.8 1.6 (14.1) 19.6 1.3 4.9 (17.9) 1.3 10.0 (9.1) 0.8 2.2 (2.2) 0.1 40.3 (38.2) 76.3 (3.2) 12.2

EBITDA Margin (%) APAT (Rs bn) Adj. EPS (Rs/sh) 4Q QoQ YoY 4Q QoQ YoY 4Q 3Q 4Q FY18E (bps) (bps) FY18E (%) (%) FY18E FY18 FY17 22.8 92 108 10.0 14.1 (18.1) 4.2 3.8 6.1 20.3 (62) 617 3.3 (16.5) (640.9) 4.2 5.3 4.7 23.7 (215) 388 5.3 (3.1) 36.5 5.1 4.9 3.2 19.3 200 95 3.8 70.6 (0.5) 8.4 10.1 14.0 19.6 (58) 320 3.0 (11.0) (4.8) 17.9 17.2 28.3 22.7 (99) 264 5.7 (3.3) 10.7 9.8 13.3 9.9 34.7 178 (192) 2.8 16.7 (2.6) 10.6 7.4 10.1 11.2 (946) (71) 1.3 (21.4) (1.5) 11.3 26.8 19.5 24.0 (29) 344 2.1 259.9 1.3 12.3 12.1 13.5 16.2 281 (427) 1.7 83.2 711.4 10.6 7.4 10.1 20.4 21 129 2.0 (5.4) 34.1 12.6 8.2 7.7 20.5 (180) 228 0.9 (23.4) 0.3 5.0 6.4 4.6 16.7 28 (98) 1.0 11.7 (11.8) 11.2 1.9 27.2 27.7 130 20 0.6 33.7 31.2 3.5 3.0 2.0 PHARMACEUTICALS : 4QFY18E RESULTS PREVIEW 18.3 25 (350) 0.4 13.1 (13.3) 1.6 1.8 1.5 10.0 151 (561) 0.0 52.2 (78.4) 2.1 1.4 9.6 21.2 (13.3) 173.7 44.0 9.0 13.9

Source: Company, HDFC secHDFC Inst Research Source: Company, sec Inst Research

Peer Valuation  

Company

Mcap CMP Reco (Rs bn) (Rs/sh)

Sun Pharma 1,241 Cipla 447 Cadila Healthcare 400 Lupin 348 Dr Reddy's Labs 350 Aurobindo Pharma 357 Divis Labs 298 Alkem Labs 210 Torrent Pharma 223 Glenmark Pharma 158 Jubilant Life Sciences 130 Alembic Pharma 94 Strides Shasun 57 Dishman Carbogen 54 Granules India 27

516 556 390 773 2,061 610 1,121 1,758 1,315 558 813 500 639 333 107

NEU NEU BUY BUY NEU BUY NEU BUY BUY BUY BUY NEU BUY BUY BUY

TP 544 631 523 1,219 2,320 835 1,100 2,124 1,748 781 1,020 575 990 480 177

EPS (Rs/sh) FY17 FY18E FY19E FY20E 26.0 14.0 20.1 27.2 12.5 18.4 25.7 33.2 14.5 11.3 16.4 22.7 33.4 18.5 43.9 64.2 72.7 64.7 116.0 161.0 39.3 35.2 46.0 52.2 39.9 33.4 44.9 51.7 74.6 62.6 85.0 106.2 51.2 38.9 62.0 79.5 29.6 18.5 30.0 43.8 37.0 41.3 62.2 77.2 21.4 23.1 25.2 31.9 34.0 27.7 39.0 59.4 9.0 9.9 15.2 22.4 7.5 6.0 8.5 11.8

P/E (x) FY17 FY18E FY19E FY20E 19.9 36.9 25.6 19.0 44.5 30.2 21.6 16.7 26.8 34.4 23.8 17.2 23.2 41.7 17.6 12.1 28.4 31.8 17.8 12.8 15.5 17.3 13.3 11.7 28.1 33.5 25.0 21.7 23.6 28.1 20.7 16.6 25.7 33.8 21.2 16.5 18.9 30.2 18.6 12.7 22.0 19.7 13.1 10.5 23.4 21.6 19.8 15.6 18.8 23.1 16.4 10.8 37.0 33.7 21.9 14.9 14.3 18.0 12.7 9.1

RoE (%) FY17 FY18E FY19E FY20E 17.9 9.1 12.3 14.8 7 8.4 11.2 14.0 15.8 23.5 15.4 19.0 22.3 12.2 6.1 13.3 17.2 9.5 8.4 13.9 17.0 27.6 20.0 21.4 20.0 22.0 15.7 18.8 19.0 21.9 15.8 18.8 20.2 22.1 14.9 21.5 23.2 18.1 9.8 14.0 17.5 18.0 17.6 22.1 22.4 23.0 21.1 19.7 21.1 13.1 4.6 12.9 17.1 16.3 14.9 17.6 20.2 21.0 13.7 15.3 18.9

Source: Company, sec Inst Research Source: Company, HDFC secHDFC Inst Research

  

Amey Chalke

HDFC securities

34 ◄ May 2018

Institutional Equities Unit No. 1602, 16th Floor, Tower A, Peninsula Business Park Se napati Bapat Marg. lower Pare I., Mumbai- 400 013 Board:+91-22-6171 7330 www.hdfcse c.com

Pharma Bio World

8

marketing initiative

B&R India launches enhanced customer support Dedicated hotline ensures high quality support and accelerated response times

B&R India has launched World Class Support – a dedicated support hotline that will serve as a single point of contact for its customers nationwide. Customers served by B&R India headquarters in Pune and its six branch offices will now have a single number to call, ensuring that they receive a consistently high level of support with the fastest possible response times. “We are proud of the best-in-class service and support we offer our customers,” says Jhankar Dutta, Managing Director of B&R India. “Our World Class Support hotline will further enhance our customers’ experience, in turn enabling them to offer their customers faster service and reduced machine downtime.”

Just a call away B&R’s online Support Portal allows customers worldwide to create and track support requests and share support documentation via the B&R website. With the new hotline, customers of B&R India also benefit from streamlined telephone support from a local team of experts. “Our highly qualified support team is committed to our customers’ success and has

the expertise it takes to help them gain a competitive edge in their market,” says Ravishankar Gawhade, head of national support, B&R India.

The number for the World Class Support hotline is +91 83 80 800 008.

About B&R B&R is an innovative automation company

World Class Support hotline to enhance customer experience Pharma Bio World

with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group. As a global leader in industrial automation, B&R combines stateof-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated

safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations.

For details Contact : B&R Industrial Automation

Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com May 2018 ► 35

marketing initiative

Data acquisition, evaluation and transmission to the cloud B&R presents powerful Edge Controller at Hannover Messe

A single device to acquire data, evaluate it and send it to the cloud – that’s now possible with B&R’s Edge Controller. The powerful industrial PC can even be used for big data analysis and machine learning, while at the same time serving as a full-fledged industrial controller.

B

&R’s Edge Controller is based on the robust Automation PC 910, whose high-performance variant is equipped with an Intel XEON processor able to handle resource-intensive tasks like machine learning. The Edge Controller runs a hardened operating system – a commercial Linux variant with guaranteed long-term support. Cloud transmission occurs via MQTT.

Full-fledged industry controller

via the POWERLINK Industrial Ethernet protocol, OPC UA or other fieldbus systems.

In the future, this will also be possible with OPC UA TSN.

B&R Hypervisor makes it possible to simultaneously run a real-time operating system on the Edge Control-ler. That turns the edge device into a full-fledged industrial The Edge Controller makes it possible to controller with cycle times in the sub- acquire data, evaluate it and then send it to millisecond range. An unlimited number of the cloud.

I/O modules or controllers can be connected About B&R

B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group.

As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations.

For details Contact : B&R Industrial Automation

Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com 36 ◄ May 2018

Pharma Bio World

marketing initiative

Just the right dose of intelligence Nothing herein shall constitute an offer to sell, or a solicitation of an offer to buy. The ACOPOStrak product is not available for sale into the United States of America until September 2018.

H

ybrid transport makes personalized mass production profitable

At the Hannover Messe, B&R showed for the first time how ACOPOStrak can be combined with convention-al conveyor belts. This brings the flexibility of the intelligent ACOPOStrak track system together with the low cost of a conveyor system – the perfect recipe for more cost-effective mass customization.

Seamless shuttle hand-off One intelligent station on the path through the production line is all it takes to create a mass customized product.

Product transport is handled almost entirely by low-cost conveyor belts – except for the one sta-tion where the

products are personalized. That’s where the intelligent ACOPOStrak comes into play. Since both systems use the same guide rails, the transitions between them are seamless.

The intelligent ACOPOStrak transport system combines perfectly with conventional conveyors.

Mass customization for brownfield plants

B&R is an innovative automation company with headquarters in Austria and offices all around the world. On July 6, 2017, B&R became a business unit of the ABB Group.

As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industri-al automation is driven by a commitment to simplifying processes and exceeding customer expectations.

ACOPOStrak combines the motor and electronics into a single unit with the power electronics and a powerful processor integrated right in the motor housing. No additional inverters or motion control units are re-quired, making the intelligent transport system extremely compact. Thanks to the modular design, it is easy to integrate ACOPOStrak segments of various lengths into an existing plant.

Mass customization done economically:

About B&R

For details Contact : B&R Industrial Automation

Corporate Communications t +43 7748 6586-0 press@br-automation.com B&R-Strasse 1, 5142 Eggelsberg, Austria Website: www.br-automation.com Pharma Bio World

May 2018 ► 37

marketing initiative

Agilent to Showcase Latest Analytical Solutions at Two Scientific Symposiums in India

A

gilent Technologies Inc. (NYSE: • A suite of innovative Raman A) today announced that it will be spectroscopy instruments, acquired hosting two scientific symposiums last year when Agilent bought Cobalt in India this summer, both featuring Light Systems, a UK-based developer industry speakers, interactive workshops, of innovative technologies for nonand Agilent’s latest analytical solutions. invasive, through-barrier chemical analysis for use in pharmaceutical and The first edition of the Total Agilent public-safety applications.

Experience, held in Mumbai last year, drew 300 scientists and researchers from Using the sophisticated, user-friendly across the country. technologies offered by these platforms, scientists are now able to work on a This year’s symposiums will take place in wider range of challenging applications Ahmedabad, 13th June, and Hyderabad, with improved performance and ease 20th June. of use, while also increasing laboratory productivity and economic value.

“The Total Agilent Experience offers unparalleled opportunities for scientists and “We will also feature interactive workshops industry leaders to talk about new ways to where participants can discuss their solve problems and make their laboratories thorniest challenges with Agilent experts more efficient,” said Bharat Bhardwaj, country and other thought leaders in the food, manager for Agilent in India. pharma, and applied chemical industries,” Bhardwaj said.

On display at the two symposiums will be Agilent’s latest chromatography, In addition, Agilent will be hosting a mass spectrometry, and spectroscopy Pharma Regulatory Summit and an platforms, including: Analytical Summit for Applied Markets. In each of these summits, industry experts • The Agilent Intuvo 9000 GC system, will share their insights on the emerging which features click-and-run trends that are driving adoption of new connections that eliminate ferrules, technologies. guard-chip technology that extends column life, and a trim-free column that About Agilent Technologies eliminates retention time shifts due to trimming.

Agilent Technologies Inc. (NYSE: A) is a • The Agilent Ultivo Triple Quadrupole global leader in life sciences, diagnostics, LC/MS system, which delivers robust and applied chemical markets. With more performance, superior uptime, and than 50 years of insight and innovation, easier serviceability, in a footprint Agilent instruments, software, services, that is 70% smaller than previous solutions, and people provide trusted instruments. answers to customers’ most challenging 38 ◄ May 2018

questions. The company generated revenues of $4.47 billion in fiscal 2017 and employs 14,200 people worldwide.

Bharat Bhardwaj

India Country Manager Agilent India Pharma Bio World

marketing initiative

Safety in grey Same quality – value enhanced

E

lesa+Ganter always strive to be attentive and adhere to customer needs.

CFSW. hinges with built-in safety multiple switch and the complementary CFMW. hinges, already available in black colour, have also been introduced in grey RAL 7040 (C33). This particular grey tonality has been chosen from the R&D department to offer an alternative for designers. Keeping a consistent colour match between components can be important, especially when using aluminium structures. Both colour schemes share the same quality, mechanical features and reliability.

Safety switches: different combinations of contacts with positive opening.

Quick assembly by means of 4 screws (front or back side).

Approved by IMQ and UL.

Tamper-proof thanks to the special covers of the mounting screws.

Double insulation: thanks to the SUPER-technopolymer housing, the hinge guarantees the double insulation of the internal circuits, therefore there is no need of grounding connection.

High mechanical strength: life-span over 1 million operating cycles.

Corrosion resistance: protection class IP67 withstanding water jets washings.

The CFSW., coupled with its complementary mechanical hinge CFMW. represents a complete system combining safety and style.

Products technical data sheets, along with drawings and tables with codes and dimensions, are available on our website www.elesa-ganter.in

Easy installation on different types of profile systems with or without slots.

For details Contact : Elesa and Ganter India Pvt. Ltd. A-54, Sector - 83, Noida 201 305 (U.P.) INDIA Tel. +91 120 472 6666 Fax +91 120 472 6600 info@elesaganter-india.com Pharma Bio World

May 2018 â–ş 39

marketing initiative

Innovative Vacuum Solutions in Pharmaceutical Industry The Right Solution from Toshniwal

V

acuum pumps and systems are common place across a tremendous range of industries. Once the essential principles are understood, the possibilities for application become apparent.

In order to properly select a vacuum system, the principles of basic vacuum technology should be understood. Once the application is clearly defined, a solution can be found by applying these methods. Since we understand and can relate to atmospheric pressure, it is chosen as a reference point.

Vacuum is simply a pressure that exists below atmospheric pressure.

To create a vacuum in a vessel, a vacuum producing device needs to remove mass from it. The more mass that is removed, the lower the pressure that exists inside the vessel.

This is why it is important to understand what vacuum is and how to select the right type of equipment. It is very important to size vacuum piping correctly to minimize pressure loss. The greater the pressure loss, the larger the vacuum equipment needs to be.

The type, quantity of gas handled, and the operating pressure, normally defines what vacuum pump can be used. If the gas consists

of mainly non-condensable, then most types of pumps can be used. If the gas consists of non-condensable and condensables, then the choices will be limited. Therefore a right solution considering the load of condensable and ultimate vacuum should be struck.

System selection To select the best type of system for a particular application, the following list needs to be considered. Once it is determined which criteria is the most important from the list, then the vacuum pump that best meets this can be selected.

• Operating cost • Solvent recovery • Effect on process • Materials of construction • Operating range • Reliability • Waste generation • Pollution abatement • Emission reduction • Maintenance cost • Ease of cleaning • Serviceability • Purchase price Pharmaceutical and Chemical Industry The pharmaceutical and specialty chemical industries use vacuum for distillation and drying. Various types of dryers are used to purify products under vacuum. The chemicals are precisely mixed and then heat is applied in the dryer to evaporate the excess chemicals. This is done under vacuum for

purer end products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost.

A typical setup used for this application is: • Combining mechanical roots blower along with oil lubricated vacuum pump.

This kind of setup is used to minimize utility costs, drying cycle time and contamination.

A properly designed process condenser between your vacuum process and vacuum producing system will yield significant advantages. A process vacuum condenser can significantly reduce the size of the vacuum producing system, recover for reuse valuable product carried from your process with non-condensable gases, reduce amount of wastes produced by the vacuum system, and lower the operating cost of your process.

Matching a vacuum condenser with the vacuum producing equipment is the best way to meet the objectives of your process.

Toshniwal manufactures both the process condenser and the vacuum producing equipment. This single-source responsibility provides you with a unitized system matched to your process.

For details Contact : Toshniwal Instruments(Madras) Pvt Ltd 267,Kilpauk Garden Road Chennai - 600010 Contact: +91 4426445626 / 8983 Email: sales@toshniwal.net Website : www.toshniwal.net 40 ◄ May 2018

Pharma Bio World

press release Takeda to Buy Shire for USD 62 billion Takeda Pharmaceutical agreed to buy London-listed Shire for 45.3 billion pounds (USD 62 billion), the biggest yet in a wave of deals sweeping the drugs industry.

Assuming it wins the backing of shareholders, the deal will be the largest overseas purchase by a Japanese company and propel Takeda, led by Frenchman Christophe Weber, into the top 10 rankings of global drugmakers.

The tie-up crowns a hectic few months of M&A activity as big drugmakers, including Novartis and Sanofi, have brought in promising medicines developed by younger firms.

The enlarged group will be a Japanese national champion in pharmaceuticals and a leader in gastroenterology, neuroscience, oncology, rare diseases and blood-derived therapies, used for serious conditions such as hemophilia.

Shire has profitable businesses selling drugs for hyperactivity and rare disorders but the size of the deal will make Takeda one of the most indebted drugmakers, prompting Standard & Poor’s to warn of a potential credit downgrade.

To pay off debts quickly, Takeda plans to slash thousands of jobs and cut back on duplicated drug research.

The deal, struck on the last day Takeda had to make a firm bid, is around 46 percent cash and 54 percent stock, leaving Shire shareholders owning around half of the combination.

Shire had rejected four previous offers, due to price concerns and the fact that the Japanese company is proposing to pay for much of the acquisition in stock.

Shire investors will receive $30.33 in cash and either 0.839 new Takeda shares or 1.678 Takeda American depositary shares for each share, valuing the offer at 48.17 pounds a share based on the latest price and exchange rate.

That is a 60 percent premium to the price before Takeda first declared its interest six weeks ago.

Boehringer Ingelheim Opens New Veterinary R&D Centre in China Boehringer Ingelheim, the world’s second largest animal health company, has been boosting its investment in China by expanding the Asian Veterinary Research & Development (R&D) Center to enhance its research and innovation capacity. The company’s new integrated R&D Center has been officially inaugurated. Located in Shanghai’s Zhangjiang Hi-tech Park, the R&D Center is currently the country’s largest integrated animal health R&D facility in terms of investment value, and is equipped with world-class R&D capabilities.

Initially put into operation in March 2012, Boehringer Ingelheim’s Asian Veterinary R&D Center, the largest of its kind established by a Pharma Bio World

multinational pharmaceutical company in China, has been dedicated to discovering and developing innovative solutions to address specific livestock diseases in China and Asia. Therefore, it has set the high starting point of the new integrated R&D center and its long-term leading strength. In January 2017, Boehringer Ingelheim and Merial officially merged, and have been going through integration since.

With the inauguration of the new integrated R&D center, the teams from both companies have now joined their forces in the R&D center, which will leverage the broad R&D expertise to create powerful collaboration in veterinary R&D capabilities.

The new integrated R&D center has a total investment of 19 million euros, covering a total area of 3,300 square meters. More than 110 researchers work at the center, led by eight international experts and 19 scholar returnees from overseas. In the meantime, Boehringer Ingelheim’s 8,000-square-meter Veterinary Trial Center (VTC) in Taizhou, with an investment of 16 million euros, has come into operation. As part of the new integrated Asian Veterinary R&D Center, VTC is the base to conduct animal trials during veterinary R&D. Up till today, the accumulated operation cost of the new integrated Asian Veterinary R&D center has reached 125 million euros.

Chugai Pharma Receives Taiwan FDA Approval for Alecensa Chugai Pharmaceutical Co., Ltd. announced that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for “Alecensa,” anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of “patients with ALK-positive, advanced non-small cell lung cancer (NSCLC).”

“The results of the J-ALEX study conducted by Chugai and the ALEX study conducted overseas showed that Alecensa will greatly contribute to the treatment of patients who receive at an early stage.” said Dr. Yasushi Ito, Chugai’s senior vice president, co-head of project & lifecycle management unit. “Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region.”

This approval is based on results from the phase III ALEX study. The ALEX study evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line).

In the study, Alecensa significantly reduced the risk of disease worsening or death by 47% (primary endpoint, HR=0.53, 95%CI: 0.38-0.73, stratified log-rank test, p<0.0001) compared to crizotinib as assessed by independent review committee. Median progressionfree survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib.

The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

May 2018 ► 41

press release Hikma Pharma Launches Basilea’s Hospital Antibiotic Zevtera in Saudi Arabia

The FDA approval was based on a comprehensive data package submitted by Pfizer demonstrating a high degree of similarity between Retacrit and its US reference product, Epogen and Procrit.

Basilea Pharmaceutica Ltd. announced that its partner Hikma Pharmaceuticals LLC has launched Basilea’s hospital antibiotic Zevtera (ceftobiprole) in Saudi Arabia.

In the US, Retacrit is indicated for: Treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis; Zidovudine in HIV-infected patients; The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy; Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Adesh Kaul, chief corporate development officer, said: “We are very pleased with the launch of Zevtera in Saudi Arabia. This is the first launch by our partner Hikma, a leading pharmaceutical company in the Middle East and North Africa region. Infections with bacteria resistant to established antibiotics remain a major health care concern across this region. Following the market entry in Saudi Arabia we are therefore looking forward to Hikma expanding the availability of Zevtera to further countries in the Middle East and North Africa.”

Zevtera is approved in Saudi Arabia for the treatment of adult patients with hospital-acquired pneumonia (HAP), excluding ventilatorassociated pneumonia (VAP), and for the treatment of communityacquired pneumonia (CAP).

Basilea entered into a distribution and license agreement for Zevtera with Hikma in 2015 and for the antifungal Cresemba (isavuconazole) in 2016. Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillinsusceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.1 Ceftobiprole is approved for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).1 It is marketed in major European countries, Argentina, Canada and Saudi Arabia. Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. Ceftobiprole is currently in a phase 3 clinical program for registration in the US.

Pfizer’s Biosimilar Retacrit Gets US FDA Nod Pfizer Inc. announced the US Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen and Procrit (epoetin alfa), for all indications of the reference product.

Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the US. “As the first approved epoetin alfa biosimilar in the US, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients,” said Berk Gurdogan, US Institutions President, Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”

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HedgePath Pharma Receives Expanded US Patent Coverage HedgePath Pharmaceuticals, Inc. (HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialise innovative therapeutics for patients with cancer, announced that the US Patent and Trademark Office (USPTO) has issued a new patent to HPPI which expands the company’s patent portfolio.

The new patent is entitled “Treatment and Prognostic Monitoring of Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors.” The claims covered by the patent relate to the use of the already FDA-approved anti-fungal drug itraconazole being re-purposed by HPPI to treat cancer. A patented formulation of itraconazole is being studied by HPPI as a product candidate for the treatment of cancer.

Nicholas Virca, HPPI’s president and chief executive officer, stated, “This new patent, which has 21 claims, relates to methods for treating cancer by orally administering a formulation of itraconazole that confers superior bio availability compared to conventional formulations of itraconazole. The patent covers treatment of hematologic cancers, such as leukemia or lymphoma, as well as non-hematologic cancers including lung, ovarian, breast, brain and pancreatic cancers. The patent claims also cover treatment of prostate cancer, basal cell carcinoma, and other cancers, and monitoring subjects undergoing such treatments based on biomarkers and other criteria predictive of efficacy. Issuance of this patent strengthens and expands the scope of patent protection provided by our first patent, US Patent No. 9,192,609, which issued on November 24, 2015.”

The basic premise behind HPPI’s proposed therapy is that in certain cancers, the Hedgehog pathway, a major regulator of many fundamental cellular processes, malfunctions, thus leading to the formation of cancerous cells. Itraconazole appears to act on the essential Hedgehog pathway component called Smoothened (SMO) in a manner that is different than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by Hedgehog stimulation. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it has less side effects than vismodegib Pharma Bio World

press release Daiichi Sankyo Introduces Naruvein Injection in Japan to Treat Cancer Pain Daiichi Sankyo Company, Limited has launched in Japan Naruvein injection 2 mg • 20 mg (generic name: hydromorphone hydrochloride) for cancer pain treatment.

Hydromorphone hydrochloride is an opium-based narcotic analgesic that has been sold for more than 80 years outside Japan and positioned as the standard drug for pain management in the World Health Organization (WHO) guidelines for cancer pain treatment.

Joining the currently marketed extended-release formulation, Narusus tablets, and immediate-release formulation, Narurapid tablets, the injection formulation, Naruvein injection, is a new addition to Daiichi Sankyo’s analgesic line-up to help meet the diverse needs of patients and health care professionals in Japan.

Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs. Daiichi Sankyo decided to develop the drug in 2012, and received a grant from the Pharmaceutical Development Support Center for its development.

Daiichi Sankyo is committed to making unapproved and off-label drugs with high medical needs available to the patients who are waiting for them.

20 minutes, as compared to over 20 hours using traditional CPU based message. The DRAGEN platform offers accuracy, speed and scalability allowing customers of all sizes to emphasize on what is most significant– delivering breakthrough results. The all-inclusive set of DRAGEN pipelines can be run onsite, in the Cloud or through a seamless hybrid cloud blend, facilitating organizations to scale as their throughput fluctuates.

AstraZeneca Sells Seroquel to Luye Pharma British pharma company AstraZeneca said it had sold the rights for Seroquel, a treatment for schizophrenia and bipolar disease, to Luye Pharma Group for USD 538 million, as part of a strategy to focus on other therapy areas.

AstraZeneca said it had sold the rights for the treatments, named Seroquel and Seroquel XR, in the UK, China and other international markets, in a deal which will give it USD 260 million once the transaction closes, followed by future payments.

“The agreement with Luye Pharma is in line with AstraZeneca’s strategy to focus on three main therapy areas while maximising the value from our legacy medicines like Seroquel,” said Astra’s executive vice president Mark Mallon in a statement.

Sciformix Launches Safety and Risk Management Technology Platform for Life Premas Life Sciences Announces Science Customers Partnership with Leading Secondary Sciformix Corporation, a leading scientific knowledge-based services organization, has launched a platform of new technology solutions Analysis Provider Edico Genome Premas Life Sciences and Edico Genome has announced a new sales distribution agreement, appointing Premas Life Sciences as the sole distributor of Edico Genome’s DRAGEN Bio-IT Platform in India. DRAGEN delivers industry leading speed and accuracy, earning top marks for its accuracy in the latest PrecisionFDA Challenge and two Guinness World Records™ for its speed.

Through this partnership, Premas Life Sciences will bring Edico Genome’s best-in-class DRAGEN Bio-IT Platform and comprehensive suite of DRAGEN pipelines to life science organizations throughout India.

“We are proud of our association as the sole distributor for the leading secondary analysis solution provider for next-generation sequencing (NGS),” said Praveen Gupta, Managing Director of Premas Life Sciences. “Genome Centers and Researchers in India will greatly benefit from the flexibility, speed and accuracy that the DRAGEN platform delivers for their projects.”

Leveraging field-programmable gate array (FPGA) technology, DRAGEN can process an entire human genome at 30x coverage in Pharma Bio World

to greatly expand its capabilities to offer end-to-end solutions in the area of Safety & Risk Management. This expansion is part of Sciformix’s strategy to address today’s unmet technology services needs for life sciences customers.

For life science organizations, the journey from pharmacovigilance (PV) system selection to a production-ready, optimized PV technology platform is a time consuming, costly process that requires significant experience and knowledge. As the requirements of technology infrastructure and regulatory compliance increase in complexity, the effort required to implement and maintain PV information systems also expands.To reduce this complexity, Sciformix has enhanced its capabilities by launching the Sciformix Safety and Risk Management Technology Platform. The platform includes best in class industry solutions, internally developed integrations and automations, proprietary IT QMS processes, and expertise to provide end-to-end safety services.

Sciformix is now hosting and offering 3 new market leading solutions that can be deployed as a standalone or an integrated solution set. These gold standard solutions are cloud based, compliant and secure making them easy to deploy, scale and maintain for today’s ever changing environments.

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press release US FDA Approves Granules Generic Methylergonovine Tablets Granules India Ltd. announced that the US FDA has approved its Abbreviated New Drug Applications (ANDA) for methylergonovine 0.2 mg tablets. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited. The approved ANDA is the bioequivalent to the reference listed drug product (RLD), Methergine 0.2 mg.

Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage.

“Granules Pharmaceuticals Inc., our R&D and manufacturing subsidiary in Virginia was established with an objective to foray into the development and manufacture of products that are niche, on several levels. Our first product approval from this site is a “first generic,” to the market and is a testimony to our objectives and execution capabilities,” said Krishna Prasad Chigurupati, chairman and managing director, Granules India Limited.

Granules India is a growing pharmaceutical manufacturing company with best in class facilities and is committed to operational excellence, quality and customer service.

Epygen to Raise ` 300 Cr to Propel Biosimilars in India After having spent seven years on technology incubation in India and more than a decade of Biotechnology research abroad, Epygen Biotech, one of the leading privately held biotechnology companies in India plans to raise ` 300 crore in the next three years to fuel launch of its exciting Biosimilar pipeline.

The funding will provide Epygen with the best possible conditions to propel clinical trial programs of its pipeline molecules in the field of Oncology and Cardiology, which are showing substantial promise in protein expression and purification.

With several decades of recombinant protein background, the company aims to take a lead role in the biosimilar field in the region. From a pipeline full with E Coli and mammalian proteins, the company has chosen to launch a stepping stone Biosimilar Recombinant Streptokinase (rSK) for the cardiovascular segment in India by 2019. This product is of utmost national interest as 17 lakh people die of heart attack in India every year and other thrombolytic proteins is more than ten times in cost.

This technology is befitting to the current programme assuring “Healtahcare for all”.

The company is upgrading its R&D capabilities setting up a 1,00,000 sqft Biopharmaceutical facility in Patalganga, Maharashtra, where Phase-I of the Project is dedicated to E Coli based biosimilars for Cardiovascular, Oncology and Rheumatology and Phase-II to make 44 ◄ May 2018

mammalian cell based monoclonal antibodies for Oncology, jointly targeting more than $ 10 billion market. The fresh fund infusion would be utlilized for clinical trials of the pipeline molecules and securing intellectual property (IP) for a range of medium and late stage technologies for Novel Biological Entities in Oncology and CNS segments.

Intas Pharmaceuticals brings down Cancer treatment cost by 60% Intas Pharmaceuticals Limited, India’s one of the fastest growing pharmaceutical company, is pleased to announce a big step which will bring relief to large number of cancer patients in the country for whom the drug - Bevacizumab was out of reach till today. Intas’s bevacizumab therapy is priced at Rs. 39995 for the dose strength of 400 mg variant which makes it 60% less than the currently available options.

Every year over 7 lakh patients die due to various types of cancer in India. At Intas we believe in the philosophy of “Patient First”. Hence, in order to relieve the patients from the financial burden associated with the treatment, this cost effective measure is implemented by the organisation. The step is entirely focussed in making the drug treatment accessible to cancer patients in India thus, providing them with a beacon of hope in their fight against the disease.

Bevacizumab is a drug which works by slowing the growth of new blood vessels and is used in treating multiple-cancers like colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma (a type of brain tumour). The drug has been available in India since 2004 but the cost has been so prohibitive that as per eminent clinicians of the country they have been able to give this drug to very few eligible patients.

Cipla to Market MannKind's Afrezza in India Cipla, a `14,280 crore plus fourth largest pharma major, has entered into an exclusive marketing and distribution agreement with USbased MannKind Corporation for Afrezza in India. Afrezza is the only US FDA approved inhaled insulin available for patients suffering from diabetes.

Available by prescription, Afrezza (insulin human) inhalation powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.

Pharma Bio World

Environmental Air Sampler The Air Trace environmental air sampler is a state-of-theart slit-to-agar microbial air sampler. The sampler rotates a 150-mm agar plate through 360o while maintaining the agar plate at a fixed distance from a precision laser-cut slit a critical feature to ensure max validated recovery of impacted organisms on the agar surface. After incubating the place, growth on the medium can be interpreted for exactly when the contamination occurred during sampling, enabling the operator to pin-point a particular event during a process or procedure that may have raised the bio-burden to above acceptable limits.

For more information, please contact: Aimil Ltd Naimex House A-9 Mohan Co-operative Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Real-time Microbial Monitor The BioLaz real-time microbial monitor provides real-time detection of biological organisms in controlled environments used for the manufacture of sterile products. The sensor can be connected directly to pharma Net, FacilitySight or your own software, and is designed to operate unattended for continuous operation. The BioLaz has been independently tested to meet the rigorous requirements of USP <1223> validation of alternative microbiological methods and of EP 5.1.6.

For more information, please contact: Aimil Ltd Naimex House A-9 Mohan Co-operative Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

Process Photometers Modern photometers enable accurate and reproducible concentration measurement by determining UV absorption, colour, NIR absorption, turbidity and cell growth. Due to their simple measuring principle, fast response time, low maintenance requirements and low dependence on or cross-sensitivity with other process parameters, they can be used in a huge variety of applications. Their hygienic design means that these process photometers are ideally suited for use in the food and life sciences industries. With an approval for use in hazardous areas, they can also be used in the chemical, and oil and gas industries. Inline measurement replaces time and labour intensive sampling and measurement in a lab and also prevents product contamination. This saves the customer time and money. All process photometers are connected to a Memograph CVM 50, which offers measured value acquisition and data management with FDA-compliant data security. Thanks to numerous communication protocols and interfaces, it can be seamlessly integrated into process control systems.

For more information, please contact:

Endress+Hauser (India) Pvt Ltd 7B, 7 th Floor, Godrej One Pirojshanagar, Vikhroli (E) Mumbai 400 079 Tel: 022-30236100 Fax: 91-022-30236219 E-mail: info@in.endress.com

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Benchtop LC-MS Mass Spectrometer The sensitivity, selectivity, flexibility and ease-of-use provided by hybrid quadrupoleOrbitrap mass spectrometers set the standard for screening, quantitation, identification and confirmation of targeted and untargeted compounds. The Thermo Scientific Q Exactive Focus hybrid quadrupoleOrbitrap MS makes this power accessible to environmental, food safety, clinical research, forensic toxicology, and pharma labs challenged by growing sample volumes and constrained by strict budgets. The Exactive Focus system simplifies method development, saving time and decreasing costs while reliably delivering unsurpassed results.

For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67420404 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

Miniature Laser Sensors The new O300 miniature laser sensors with IO-Link by Baumer are the specialists for the reliable detection of very small objects and gaps. Thanks to a laser beam which focuses to within 0.1 mm and the high repeat accuracy of 0.1 mm, objects can be positioned with high precision and follow-up processes controlled exactly. Thanks to the extremely short response time of less than 0.1 ms, the sensor reliably detects even closely spaced objects, thus allowing fast processes and high throughput rates. A big advantage is the exact alignment of the laser beam to the fixing holes by design (qTarget). Thanks to qTarget, detection with pinpoint accuracy can be guaranteed over the entire series.

For more information, please contact:

Baumer India Pvt Ltd Fourhum Centre, S No: 112/2/21, 112/2/64 & 112/2/72 Opp: RMD Sinhgad Institute Mumbai-Pune Highway, Warje Pune, Maharashtra 411 058 Tel: 020-66292400, Fax: 91-020-66292445 E-mail: sales.in@baumer.com

Rotocone Vacuum Dryer The rotocone vacuum dryer is suitable for drying the material which cannot operate at high temperature, easily oxidised, poisonous in nature.

Rotocone vacuum dryers are available in Models 10 to 2,000 litre working capacity.

Double cone shape and jacketed container is rotated on slow speed to gently tumbling of products with under the state of vacuum inside the shell, pass heating media into jacket for heating and dries products inside the container on desired temperatures and vaporised steam exhaust from container through vacuum. Vacuumizer closed system with condenser, receiver for solvent recovery.

Optional features include solvent receiver system, lumps breaker, PLC controls and FLP. For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC, Vatwa Ahmedabad, Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

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Pharma Bio World

TSQ Endura Triple Quadrupole Mass Spectrometer The Thermo Scientific TSQ Endura Triple Quadrupole Mass Spectrometer provides unparalleled value, with LODs and LOQs unrivalled in its class.

It delivers this best in class quantitation run-after-run and dayafter-day regardless of sample type or matrix and it does so with simplicity that takes the worry out of method development and operation.

For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

TSQ Quantum Access MAX Triple Quadrupole MS Applications such as environmental and food safety testing, clinical research and forensic toxicology demand robust analytical sensitivity and specificity even when budgets are constrained.

The Thermo Scientific TSQ Quantum Access MAX Triple Quadrupole Mass Spectrometer is an outstanding LC-MS/MS value, providing excellent sensitivity, specificity and flexibility that is also more affordable.

For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67429494 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

Mobile Microbial Air Sampler Mobile microbial air sampler simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.

It reduces error with the intuitive user interface that is icon-driven with multiple levels of security and allows the use of pre-configured recipes to avoid possible sampling errors.

It does not contaminate the cleanroom through the use of a unique HEPA-filtered exhaust. The autoclavable BioCapt Microbial Impactor and sanitizable enclosure are ideally suited for aseptic environments.

Flexibility of using one sampler for multiple sampling applications including monitoring compressed gas, remote isolator sampling and the ability to connect to the BioCapt and BioCapt Single-Use Microbial Impactor. It reduces investigation cost through the use of the BioCapt’s radial slit design.

For more information, please contact: Aimil Ltd Naimex House A-8 Mohan Co-operative Indl Estate Mathura Road New Delhi 110 044 Tel: 011-30810200 Fax: 91-011-26950011 E-mail: info@aimil.com

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May 2018 ► 47

Rotocone Vacuum Dryer

Magnetic Mixer

Rotocone vacuum dryer is available in standard cGMP and customised models with SS304/316/316L contact parts.

Features low drying temperature, fast drying; easy to clean internal surface; continuous vacuum maintenance during process; dust filter is provided to filter solid particles; and cyclone separator to recover the solid particle. Also performs max function due to rotational movement and thereby reducing the processing time. Suitable size condenser; receiver is provided for solvent recovery.

Available in batch capacities ranging from 50 to 3,000 kg, as per client’s requirements, depend on bulk density.

For more information, please contact:

IPEC Engg Pvt Ltd Plot No: 5175, GIDC Ankleshwar, Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com

Magnetic mixer is available in standard cGMP and customised models with SS304/316/316L contact parts.Vessels other than bioreactors like media preparation, buffer preparation, etc, which are part of the bioprocess require mixing. Bottom magnetic mixers are used in these types of vessels.The bottom magnetic mixers are similar to the magnetic agitator other than impellers and normally come without a shaft. The magnetic mixer is designed for liquid mixing application and complies with the most stringent cleaning ability and sterilization requirements. Bottom magnetic mixers are totally cleanable and sterilisation in place. This factor is very important in the cGMP compliant.Magnetic mixers are available in capacities ranging from 50 to 2,000 litres, as per client’s requirements.

For more information, please contact:

IPEC Engg Pvt Ltd Plot No: 5175, GIDC Ankleshwar, Gujarat 393 002 Tel: 02646-221175 Telefax: 91-02646-225175 E-mail: md@ipecengg.com / marketing@ipecengg.com

Coating Solutions Solenis offers its new Tapestry Yankee Coating Solutions to help tissue makers produce a consistently reliable Yankee coating while improving manufacturing performance and controlling operational costs.

A reliable Yankee coating is essential for the efficient operation of a tissue machine. The Solenis Tapestry Yankee Coating Solutions include the most advanced chemistries on the market to optimize Yankee performance.

Tapestry Yankee Coating Solutions enables the development of a coating that provides several benefits, including: Doctorability, Edge Control and Coating Uniformity. The resulting improvements to creping performance and tissue quality can ultimately impact a tissue mill’s bottom line through enhanced productivity and improved product quality attributes such as softness and strength. In addition, a dependable coating is a key element in protecting tissue machinery.

For more information, please contact:

Solenis 3 Beaver Valley Road, Suite 500 Wilmington, Delaware 19803 U.S.A. Tel: +1 866 337 1533 E-mail: smkukade@solenis.com / upatankar@solenis.com

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Sterility Test Kits/Canister Steritailin HTY Sterility test system is composed of Steritailin closed sterile canister and HTY sterility test pump which are regarded as Golden Standard of sterility testing for injection drugs. It achieved ISO 9001 and ISO 14001 Certificates. The united use of them keeps all process carrying out in complete closed condition, including transfer, filter and incubate which avoids exogenous contamination. According to different features and packages of the test sample, Shreedhar Instruments develop corresponding types of sterility test kits to satisfy the demand on each test sample.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com

Total Organic Carbon Analyser Shimadzu has been the market leader with its technology of TOC analyser which comprises of catalytical combustion followed by non-dispersive infrared detector (NDIR). Being one of the oldest and most recognised TOC in Indian and World Pharma market, the latest Model TOC - L Series brings the same technology for your solution of purified water, water for injection, raw water, cleaning validation and environment sample analysis.

For more information, please contact: Shreedhar Instruments 16 Shreeji Krupa Society Opp: MGVCL Circle Office Next to GMERS Medical College Gotri Road, Vadodara Gujarat 390 023 Telefax: 91-0265-2323041 E-mail: sales@shreedhargroup.com

Pharma Bio World

Flow Control Valves Cipriani Harrison’s flow control valves are made from forged SS-316L are highly polished and come standard with FDA EPDM seats and seals.

These valves have self-draining machined bodies with a round shape that allows for a minimum resistance to flow. The valve body, yoke and actuator are assembled with clamps enabling quick and easy assembly and disassembly. Available in sizes 1”-2.5” with sanitary clamp and Butt-weld end-connections as standard. The valve is operated by means of a manual handle which moves a conical plug gradually up or down. The plug has a calibrated profile that allows for fine flow control. The plug can be fixed in the desired position with a locking arrangement.

For more information, please contact: Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nagar, Anand Gujarat 388 121 Tel: 02692-235082, 235182 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

Vibro Sifter The vibro sifter works on gyratory principle. Gyro motor gives horizontal, vertical and tangential component of vibration due to which materials spread over the screen and starts rotating throughout the periphery and gets sieves from the attached mesh.

Vibro sifter is available in 12-inch R&D and 24, 30, 36, 48-inch Production Models.

For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E), Palghar Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com

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Filters & Strainers

Mass Spectrometer

Cipriani Harrison’s filters and strainers are made from SS-304 and SS-316, are highly polished and come standard with FDA silicone seals. These filters and strainers consist of a housing with an inlet and outlet either inline or 90o angle orientation.

Inside the housing is the straining element that is fixed in such a way that the product flow is forced through it. This element consists of a backup tube and straining mesh. The housing with the element assembly inside it is then fitted between two stainless steel flanges by means of sanitary clamps and gaskets. These filters/ strainers are 3A authorised.

For more information, please contact: Cipriani Harrison Valves Pvt Ltd Sub Plot No: 2, B/s Margin Impex Ltd Nr Phase IV, GIDC Estate V U Nagar, Anand, Gujarat 388 121 Tel: 02692-235082, 235182 Fax: 91-02692-236385 E-mail: info@harrisonengineers.com

The Thermo Scientific Exactive Plus mass spectrometer is easy to use, cost-effective to operate and coupled with workflow driven software, makes an ideal instrument for new users and users performing largely routine analysis. It delivers high-resolution, accuratemass (HRAM) full-scan MS for fast, precise and reproducible results and tremendous analytical confidence. The continuous acquisition of HRAM fullscan data allows retrospective data analysis for qualitative and quantitative analysis.

For more information, please contact: Thermo Fisher Scientific India Pvt Ltd 102, 104, Delphi ‘C’ Wing Hiranandani Business Park Powai, Mumbai 400 076 Tel: 022-67420404 Fax: 91-022-67429495 E-mail: sagar.chavan@thermofisher.com

High-speed Doors Prime Metallic is ideal for high security applications where speed is important, traffic is frequent and door safety concerns are paramount.

It is distinguished as extremely fast, durable, safe and low maintenance high performance door. Door panels are made from anodized double-skinned aluminium alloy with rockwool insulation. Transparent vision panels are available optionally increases visibility and light penetration into the working environment. The fast opening speed and its compact size make it possible to optimise the flow of people, trolleys and vehicles.

It has a heavy duty 400 V 3-phase motor, opening speed of up to 2.5 m/s and size up to 5,000 x 5,000 mm (W x H).

For more information, please contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre Link Road, Malad (W) Mumbai 400 064 Tel: 022-66720200 Fax: 91-022-66720201 E-mail: sales@geapl.co.in

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Pharma Bio World

Tray Dryer

Blenders

The tray drying ovens are used for drying of pharma powders, granules, pigments, foods, bakery and chemical in an effective and economical way by hot air re-circulation.

Tray dryers are available in Models 6, 12, 24, 48, 96 and 192 tray loading capacity. Wetted products dry by hot air circulation in closed insulated chamber. Machine structure inside and outside are made from SS-304 with insulation, and provided air filter and damper at inlet and exhaust.Optional features includes explosion-proof and PLC controls.

For more information, please contact: Prism Pharma Machinery Plot No: 3713, Phase IV, GIDC Vatwa, Ahmedabad Gujarat 382 445 Tel: 079-29095204 Fax: 91-079-25841623 E-mail: mkt@prismpharmamachinery.com sales@prismpharmamachinery.com

The blender is a simple machine with GMP compliance to blend dry powders, granules, etc. The geometry of blender with the baffle fitted inside the blender makes the system perfect to achieve homogenous mix in reasonable time. Blenders are available in 5, 10, 20, 30-litre R&D and 50, 100, 200, 300, 500, 1,000, 1,500, 2,000 and 3,000-litre Production Models.

For more information, please contact: Sunsai Pharma Equipments Pvt Ltd Plot No: 1, Survey No: 77 Nr Laxmi Indl Estate Sativali Road, Vasai (E) Thane, Maharashtra 401 208 Tel: 0250-3200130 E-mail: sunsai.pharma@rediffmail.com sunsaipharma@gmail.com

Blister Machine The Romaco Noack NBP 950 rotary sealing blister machine is suitable for a wide range of products. The blisters can be arranged either lengthwise or crosswise to the running direction. Numerous blister layouts with different cavity geometries can be realised in this way. This extra-ordinary flexibility as regards the format design opens up countless possibilities for manufacturers of blister packaging.

The cGMP compliant machine impresses with an advanced level of automation and format changes can be completed in a very short time.

The fully interchangeable QuickFeed unit speeds up product changes by providing a second unit. QuickAdjust – the automatic station control system – adjusts the sealing, coding and perforation processes. This saves time and materials during the run-in following a job change. The blister machine is soon prepared for the next job thanks to the optimised retooling and cleaning times.

With a max output of 500 blisters per minute, the Noack NBP 950 is the ideal solution for small to medium sized batches.

For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

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Thermoplastic Elastomer Tube (TPE) Imaprene pharma grade thermoplastic elastomer tubing designed for peristaltic pump transfer. Imaprene is opaque tubing especially known for its excellent flexibility and flex crack resistance.

Imaprene is manufactured by using world class thermoplastic elastomer. It is manufactured and packaged in dust-free environment of ISO 9001 QMS, ISO 14001 and OHSAS 18001 Certified facility. It has excellent chemical and solvent resistance (Ex. IPA). It is superior flex crack resistance and durable for peristaltic pump application. It has smooth bore to ensure least contamination. It is non-toxic and non-haemolytic.

For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate, Opp: Silver Park Mira-Bhayander Road, Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

Vacuum System Vacuum system finds application in many fields, including pharma, chemical, plastic, food and pasta production, leather chemicals and centralized vacuum systems.

Vacuum systems are variable and optimized by the selection for the application and working parameters. It is possible to decrease power, saving in the range 30-40 per cent.The condensor helps in reducing the process time of drying, distillation, etc, by effectively condensing the condensable vapours. The condensor has been standardised with 1.5-m², 3-m² and 6-m² cooling surface area.

The material of construction can be given in mild steel/SS-304/ SS-316 for shell and copper/Cu. Nickel/SS-304/SS-316 for the cooling coil.

For more information, please contact: Toshniwal Instruments (Madras) Pvt Ltd 267 Kilpauk Garden Road, Chennai 600 010 Tel: 044-26448983, 26448558 E-mail: sales@toshniwal.net

Point Level Safety Switch The Drexelbrook Safety IntelliPoint RF represents a significant advance in RF admittance reliability that addresses applications requiring safety instrumented functionality (SIF). The SIL IntelliPoint offers a full line of measurement probes to fit any process application where Safety Overfill Protection is required. This premium point level switch was designed to perform in the most challenging operating environments with extreme reliability while meeting API 2350 Overfill Protection Standards.

The IntelliPoint RF level transmitter’s range of features and functions make it suitable for use in safety-related systems with requirements for functional safety for SIL2 (SIL3 with redundant switch). It is certified in accordance with IEC61508-2 and has worldwide hazardous area approvals (FM, FMc, ATEX and IECEX-Pending).

IntelliPoint’s electronics sense changes in the probe that simulate contact with the media or a floating roof, providing users with a method to ensure proper working performance without having to climb into the tank, and it automatically recognizes and ignores coatings to prevent false alarms.

For more information, please contact: AMETEK Drexelbrook 205 Keith Valley Road Horsham, PA 19044 U.S.A. Tel: 215-674-1234 Fax: 215-674-2731 E-mail: drexelbrook.info@ametek.com

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Tableting Robot

Microdosing Machine

The Romaco Kilian STYL’ONE Evolution single-stroke press is the ideal solution for laboratory applications, whether for developing new formulations or for scaleup tests. It achieves a max output of 1,750 tablets per hour in configurations for mono-layer, multilayer or core tablets. The compression cycles have been speeded up by more than 60 per cent and the max compression force increased to 50 kN in order to simulate high speed presses. Compression force profiles for all standard rotary presses like the Romaco Kilian KTP 420X can now be determined at full power. ANALIS, the intelligent PAT software, calculates all relevant tableting parameters based on compression force or displacement controlled cycles. The remarkable precision of the test batches means powder properties can be analysed very realistically. The STYL’ONE Evolution can thus also be utilised to optimise processes or troubleshoot errors.

For more information, please contact:

Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0, Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

The Romaco Macofar MicroMaxX 18 microdosing machine processes pharmaceutical powders with different flow properties as well as freeze-dried products and sterile liquids. The system is equipped with a dual dosing disc which allows multiple dosing into the same vial; alternatively, the product can be filled in two separate process steps. Furthermore, even very small product quantities right down to 25 mg can be dosed precisely. Thanks to an innovative in-line weighing system, one hundred per cent weight control is now possible for the first time. The machine achieves a max filling speed of 12,000 vials per hour. Up to 18,000 vials an hour are possible in the version with statistical weight control. The Romaco Macofar MicroMaxX 18 can be supplied in different containment designs.

Automated processes ensure reliable operation and meet the high cGMP requirements for dosing sterile powders and liquids.

For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe, Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Solid Liquid Separation SAP Filter offers special filters for chemical and pharma applications in API for separation of activated charcoal or solids produced during the reaction of the reactants. Also, their Microbac candle filter is suitable for catalyst separation and recycles in any reactions including hydrogenation.

Candles are fabricated in pipes of equal dia and assembled together in such a way that it results into a candle which is dressed with anti-static cloth of suitable material through which filtration is affected. After scavenging the filter, the cake is washed insitu or displacement washing is another option to restrict the use of adequate ML (mother liquor). After washing the cake the filter is scavenged again and cake is discharged either dry or in slurry condition. Most suitable for activated carbon or carbon supported catalysts.

For batch filtration SAP Filter offer zero hold-up sparkler filters of various sizes. The MoC can be any stainless steel or high alloys like 904L, Hastelloy, Inconel, etc.

The zero hold-up filters are available in PP, PVDF and Teflon. Vessel-lined with PP, PVDF or Teflon and cartridge fabricated from solid block.

For more information, please contact:

SAP Filter Pvt Ltd Plot No: A-5, Sector 1 The Vasai Taluka Indl Co-op Estate Ltd Goraipada, Vasai (E), Palghar, Maharashtra 401 208 E-mail: info@sapfilter.com / sapfilters@gmail.com

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May 2018 ► 53

Hot Melt Device

This CIP innovative Innojet IHD 5 hot melt device for pharma applications complies with all GMP requirements for coating and granulation with organic waxes and fats. The fact that there is no evaporation during the hot melt process is a crucial advantage. The processing times are up to 85 per cent shorter as a result. What’s more, since there is no need to heat the air in order to dry the product, energy efficiency is improved. The IHD 5 features a design with all components – including the valve block, dosing unit and melting container – integrated in a compact, block-like housing. This makes it easy to connect the mobile device to the VENTILUS V 5 whenever this is called for by the formulation.

All laboratory equipment in the VENTILUS V 5 series can simply be fitted with the spray air heater which is essential for hot melt applications. Heating the system to 120°C prevents the coating liquid from cooling down in the feeding channels and clogging the spray nozzle. The pulsation-free application of the pharma hot melt coating ensures outstanding precision and product quality For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Processing Machine The laboratory-scale version of the Romaco Innojet VENTILUS V 5 is used for granulating, drying and coating particle sizes from 10 µm to 2 mm.

Due to its special design and enhanced processing efficiency, the VENTILUS V 5 allows up to 25 per cent shorter batch times. The homogeneous flow conditions inside the cylindrical product container enable extremely gentle intermixing of the batch. The process air is controlled by the ORBITER booster, an ingenious container bottom consisting of overlapping circular plates. Together with the ROTOJET, the central bottom spray nozzle, the ORBITER booster forms an innovative functional unit that meets all the requirements for linear scale-ups. The air flow bed technology ensures accurate control of the product movement and equally precise application of the spray liquids. The resulting formulations can achieve the required release profile with between 10 and 15 per cent less spray liquid.

For more information, please contact: Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel: +49 (0)721 4804 0 Fax: +49 (0)721 4804 225 E-mail: susanne.silva@romaco.com

Mixer Toshniwal offers new generation powder mixer, which gives a homogeneous mix in a very short time (30-60 seconds) for dry powder. The mixer has a facility for spraying liquid to ensure uniform coating on powder/pellets as well as lump breaker.

The other salient features are high degree of precision mixing up to10 PPM, low energy cost per tonne of mix, high production output with a small batch mixer, fast discharge of mixed material through two large Bombay Doors avoiding segregation of mixed material, negligible maintenance, etc. The mixer is ideally suited for food products like instant drinks, coffee/tea vending premix, gulab jamun mix, spices, cereals, bakery premix, etc.

For more information, please contact: Toshniwal 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448558 / 8983 E-mail: sales@toshniwal.net

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Humidity Chamber Mack Pharmatech offers cost-effective PLCbased stability chambers with European Standard “CE” in different capacities. Their humidity chambers temp range is 20°C to 60°C, humidity range: 40%RH to 95%RH, accuracy: ±0.2°C and ±2.0%RH, uniformity: ±1.0°C and ±3.0%RH, control system: PLC (Allen Bradly) and their stability chambers are suitable for different ICH test conditions like 25°C and 60%RH, 30°C and 65%RH, 40°C and 75%RH, 30°C and 75%RH. Also providing specially designed chambers for low humidity conditions such as 25°C and 40%RH, 40°C and 25%RH and 30°C and 35%RH. Mack Pharmatech is the only company who gives all equipment with PLC-based control system, 21 CFR software, touch screen display (HMI), standby refrigeration system, standby humidity system, imported standby hygroflex sensor, GSM technology, hooter system, password protected door system, full view glass door, GMP Model, bullet feet levelling legs, tray spacing every ½” adjustable and many more features.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com

Walk-in Humidity Chamber Mack Pharmatech offers cost-effective PLC-based walk-in-stability chambers with European Standard “CE” in different capacities.

Their humidity chambers temp range is 20°C to 60°C, humidity range: 40%RH to 95%RH, accuracy: ±0.2°C and ±2.0% RH, uniformity : ±1.0°C and ±3.0%RH, control system: PLC (Allen Bradly) and their stability chambers are suitable for different ICH test conditions like 25°C and 60%RH, 30°C and 65%RH, 40°C and 75%RH, 30°C and 75%RH. Also providing specially designed chambers for low humidity conditions such as 25°C and 40%RH, 40°C and 25%RH and 30°C and 35%RH Mack Pharmatech is the only company who gives all equipment with PLC-based control system, 21 CFR software, touch screen display (HMI), standby refrigeration system, standby humidity system, imported standby hygroflex sensor, GSM technology, hooter system, password protected door system, 8+8 scanner, full view glass door, GMP Model and many more.

For more information, please contact: Mack Pharmatech Pvt Ltd B-48 Malegaon MIDC, Sinnar Dist: Nashik, Maharashtra 422 113 Telefax: 91-02551-230877 E-mail: sales@mackpharmatech.com

Electro Magnetic Meter 65 The instrument works on the principle of Faraday’s law of Electromagnetic Induction. A magnetic field is generated by the instrument in the flow tube. The fluid flowing through this magnetic field generates a voltage that is proportional to the flow velocity. This voltage is measured by the electronics and a corresponding output provided.

Universal power supply accepts any voltage from 90 to 265 V AC. Bi-directional flow measurement measures the flow in both forward and reverse directions. Built-in totaliser provides a separate totalized volume value for flow in each direction.

Remote monitoring is easy monitoring of the process even in hard to reach places. Conforms to International Standards designed to meet global requirements and available with international approvals.

For more information, please contact: Toshniwal Hyvac Pvt Ltd 267 Kilpauk Garden Road Chennai 600 010 Tel: 044-26448558, 26448983 Fax: 91-044-26441820 E-mail: sales@toshniwal.net

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May 2018 ► 55

events diary            Date: 4 – 6 June 2018 Venue: Holiday Inn Rome Aurelia, Rome, Italy th

th

PDDS 2018 conference aims to explore Pharmaceutics, its relation with Drug Delivery Systems and application in the development of healthcare products.

Through networking and sharing, PDDS 2018 will provide an opportunity for researchers, practitioners and educators to exchange research evidence, practical experiences and innovative ideas on issues related to Pharmaceutics and Drug Delivery Systems.

Contact Tel: +1(702)-988-2320 Email: pharma@magnusscigroup.com

     

   Date: 11th – 12 th June, 2018 Venue: Holiday Inn Kensington Forum, London, UK The Global Pharmaceutical Market currently has a market value of USD 1057 billion. If a drug is found to be unsafe, causing serious side effects, it can have a huge knock on effect on revenue, causing huge losses to pharmaceutical companies manufacturing the drug.

Therefore, Drug Safety 2018 aims to discuss the latest findings and current thinking on pharmacovigilance.

Importantly, it will address the newest regulatory updates and interpretations of them, including the impact of the vital and much awaited Clinical Trial Regulations.

Contact: Pavan Solanki Tel: +44 (0)20 7827 6048 Email: psolanki@smi-online.co.uk

   

Date: 30th May – 1st June, 2018 Venue: The Westin, Mumbai

Date: 20 th – 23 rd February 2019 Venue: Bombay Exhibition Center, Mumbai

India continues to be a major player accounting for 20 per cent of global exports in generics and stood at a staggering USD 16.84 billion in 2016-17. To supplement this growth, companies need to mitigate any challenges and risks that may accompany such monumental growth.

It is of grave importance to pharma companies that quality, regulatory and compliance concerns are overcome to avoid any roadblocks along the way. Government bodies and other stakeholders will have to play a great role in establishing a strong regulatory set-up as well as a speedy redressal for related issues. Companies will have to step up their quality and manufacturing compliances in line with the global guidelines. To bridge the gap between external requirements and internal obligations, CPhI India brings to you the 7th Annual Global Pharma Regulatory Summit 2018 focusing on the clarification and interpretation of the most critical regulatory guidelines established by CSDCO, FDA, EMA, PMDA, Africa and CFDA.

BioPharma World Expo 2019 will be a perfect destination for Bioprocess Solution Providers, CROs/CMOs, Clinical Trial Supply Chain Providers, Cold Chain Packaging & Cargo, Global Pharma, Regulatory Consultants, Analytical Instrument Manufacturers, Local Biotechs & Start-ups, Quality Control Consultants, Academics, and Regulators to showcase and promote their product and services as well as offer unique opportunity to meet, network and discuss current industry trends, establish business partnerships and be updated on investment opportunities in India. The concurrent conference tracks will explore areas like biosimilars and vaccines development, antibodies, orphan drugs, stem cells, innovations in biologics manufacturing and regulatory compliance; growing issues in generic drug manufacturing and more.  Amrita Patkar Event Coordinator Tel: 91-22- 4037 3617 Email: amrita_patil@jasubhai.com

Contact: Vishal Prabhakar Mob: +91 83568 17260 Email: vishal.prabhakar@ubm.com

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Pharma Bio World

bookshelf Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems (Hardcover) Authors: Ashok Katdare, Mahesh Chaubal (Editors) Price: USD 156.00 No of Pages: 452 pages To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenues for regulatory review and allowance to use. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Handbook of Pharmaceutical Excipients (Hardcover) Authors: Paul J Sheskey, Walter G Cook, Colin G Cable (Editors) Price: USD 398.32 No of Pages: 1216 pages The Handbook of Pharmaceutical Excipients collects together essential data on the physical properties of excipients as well as providing information on their safe use and applications. All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. It is internationally recognised as the authoritative source of information on pharmaceutical excipients and a comprehensive guide to uses, properties and safety.

Excipient Applications in Formulation Design and Drug Delivery (Paperback) Authors: Ajit S Narang, Sai H S. Boddu (Editors) Price: USD 188.85 No of Pages: 681 pages In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Pharma Bio World

May 2018 ► 57

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58 â&#x2014;&#x201E; May 2018

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                             

Stand A100, Hall 5.1 11 - 15 June 2018 Frankfurt am Main Germany.