Pharma Bio World August 2019 by jasubhai

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PHARMA BIO WORLD Vol 18 Issue 01 AUGUST 2019 MUMBAI total pages 60 ` 150 BioPharma South World Expo 2019 4-6 December 2019 HITEX Exhibition Center, Trade Fair Office Building Izzat Nagar, Kondapur PO, Hyderabad, India

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4 ◄ August 2019

Pharma Bio World

Market Insight

India to Witness High Consumption of Pharma Packaging by 2024

Jayati Mukherjee

features

Pharmaceutical Packaging – an Overview Anand Khare, Consultant – Design Thinking & Packaging Innovation

Performance of Aluminium based Packaging Materials related to the Structure Dr. E. Pasbrig, GM Development and Technology, ACG Pharmapack

Serialization: Coding and Marking is Paramount to Readiness Thierry Protas, Global Pharma Director, Videojet Technologies

Simplicity or Specialism? Organizational Options for Global Labeling Functions Denis Fung, Co-founder and Lead of Labelnet, Navitas Life Sciences Louise Tan, Pharmacovigilance Subject Matter Expert, Navitas Life Sciences

Journey of SyMetric: an End-to-End Solution Provider in Clinical Trial Uma Janapareddy, Founder & Managing Director, SyMetric

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Press Release

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6 ◄ August 2019

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market insight

India to Witness High Consumption of Pharmaceutical Packaging by 2024 By Jayati Mukherjee

Packaging plays a crucial role in pharmaceutical industry, where its function extends to protect medicines from environmental changes, and to maintain physical as well as chemical stability of the drugs and biologicals for shelf life period, along with serving as a branding aid. It further helps to ensure the safety of the medicine during transit, distribution, and storage. It is increasingly playing a pivotal role in ensuring overall patient safety by carrying key information pertaining to the product, ensuring tamper-evidence, and traceability of the product. With this contextual account, the pharmaceutical industry is growing rapidly, thus impacting the growth of the pharmaceutical packaging market very positively. Here the writer has made an endeavor to give a holistic yet comprehensive view of Indian pharma packaging industry.

Economy Statistics: The global pharmaceutical packaging market size is estimated to be approximate USD 83.6 bn in Yr 2019 and is projected to reach USD 111.9 bn by Yr 2024 with a CAGR of 6.0 percent. India, China, Brazil, Argentina, South Africa, and Egypt are expected to witness high consumption of pharmaceutical packaging by 2024 due to increasing population, diseases, and technological advancements. Rising efforts to increase life expectancy coupled with 12 â&#x2014;&#x201E; August 2019

rising disposable income is expected to provide attractive growth opportunities, as companies are struggling with the stagnation of mature markets, expiration of patents, and a rise in regulatory hurdles. A flux has been noticed in the route towards establishment in the aforementioned economies. The one-size-fits-all approach cannot be adopted for emerging markets. If we consider the three main clusters of market viz. the BRICMT economies (Brazil, Russia, India, China, Mexico, and Turkey),

the second-tier countries in South-East Asia, and Africa â&#x20AC;&#x201C; there are local idiosyncrasies that make bespoke approaches to these market essentials. In context of overseas market, North America and Europe are expected to cover maximum profit over the forecast period owing to increasing pharma industry in this area. Europe is also expected to capture considerable profit over the forecast period owing to latest technological advancements that are happening in this part of the world. Pharma Bio World

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market insight

Market Size in Billion USD

Global Pharma Packaging Market Size - Now & Going Forward 120 100 80 111.9

60 40

83.6

20 0

Market Size in Bn USD Market Dynamics: A. Growth enhancing factorials: The pharmaceutical industry is on a revolutionary track to accommodate demographic, epidemiological, and economic shifts in the world. Industry players are upgrading their manufacturing practices to match the standard from time-to-time to produce world-class products. A few notable growth-factorials are: • Advanced manufacturing processes and product innovations have been contributing very significantly to the pharma packaging industry growth. • Within the most important packaging products, – inhalers, pre-fillable syringes, and other innovative and advanced products are expected to drive the future growth of the industry. • The growing generic-drug market and the drug-delivery market also

Yr 2019

Yr 2024

83.6

111.9

promote the pharma industry growth.

packaging

• The increasing requirement for drug delivery equipment is a big enhancement for the packaging companies as it demands high-quality basis and provides high profitability for the provider. • Some of the recent innovations in global context are: colour changing packages, condition monitoring RFID tags, blister packaging with childlock for effective child-resistance solution, etc. • Novel drug developments such as nano-technology and nano-medicines, leading to packaging innovations is likely to propel the pharmaceutical packaging market in the next five years. • The opportunities in pharma packaging market is expected to increase in the pre-fillable syringes

The continuous expansion of Indian Pharma Companies promotes the allied Packaging Industries to move beyond the value proposition of cost advantage. 14 ◄ August 2019

and the parenteral vials segment, which will continue to expand with the advancements in biotechnology as a result of the new-therapy introduction. • Advancements in biotechnology is often directed to the introduction of novel therapies that have to be injected. The rapid growth in the pharmaceutical packaging market is expected to approach parenteral vials, which will carry on expanding as advancement in biotechnology direct to the introduction of novel therapies that must be injected. • Demand for multi-dose and unit-dose packaging is another forward-driving factorial. • Oral drugs, injectable, transdermal and pulmonary are the rapidly growing sections in the drug deliverance business globally. The global pharmaceutical packaging industry is expected to experience a major push owing to a ceaselessly growing requirement of biologics. The growing demand for biologics will reinforce demand for pioneering product packaging system in the worldwide pharma packaging market. Pharma Bio World

market insight Advanced manufacturing processes and product innovations have been contributing very significantly to the pharma packaging industry growth. B. Restraints: The packaging industry has to overcome the challenges like the availability and prices of raw materials, and the changing rules and regulations regarding product approval and marketing. • Raw materials and packaging costs have been increased significantly in the last few years; and it is also expected that the prices will increase overall along with changes in ecological measures. • Demand to develop the sustainable eco-friendly product is also pressurizing the packaging industry. • Strict rules and regulations of packaging quality control vary across the different parts of the globe. Additionally, these regulations will continue to evolve as authorities aim to place patient safety as one of the priorities in defining regulatory guidelines. • Moreover, there is stringency in establishing the harmony between organization’s individual business goal & branding goal, with the regulation compliance. the regulatory • Harmonizing requirements with branding and marketing, and additional language translations for a label, is one of the biggest pain points. An in-depth study indicated that this is due to the amount of available space in relation

to the amount of required information. The advised way to overcome this challenge is to prioritize the artwork content. Companies are advised to incorporate only the obligatory information first, then the relevant advised content and business content in terms of marketing. Packaging and labeling specialists and solution providers are exploring the possibility on the use of a workflow-checklist and automation software for managing the label production. • Label recalls are the direct cause of supply chain disruption and financial losses. Even the smallest error on a print job requires a label recall, otherwise company brand identity risks compromization. Companies using in-house systems have a harder time than companies outsourcing the artwork production. Companies using in-house systems need to stay up to date with the latest regulatory changes and innovative technologies. • Switching to automation and bringing change into the workflow requires a well-defined strategy. But, if implemented well, it guarantees process time efficiency, risk reduction, and better regulatory compliance. C Current landscape & potential impact of global trends: While Indian pharma

In global context, North America and Europe are expected to cover maximum profit owing to increasing pharma industry and latest technological advancements. 16 ◄ August 2019

companies re-escalating themselves in the value chain, transitioning into higher value areas such as specialty pharma and new chemical entities (NCEs), the allied industries of pharma packaging have been slower to evolve. The pharma packaging industry is structured in the form of a pyramid with an extended base. At the top, there are multinationals viz. Huhtamaki, Amcor, SGD Pharma, etc with their marketing offices or manufacturing units in India. The second place is held by Indian giants viz UFlex, EsselPropack, etc. At the base, the industry is deeply fragmented with multiple smaller companies dotting the landscape, with most being generalized suppliers catering to multiple sectors along with pharma. These smaller companies tend to focus exclusively on specific parts of the value chain , whether it is in segments of primary packaging viz blister packaging, HDPE bottles, ampules etc., or in segments of secondary packaging including labels, pouches, and cartons. The continuous expansion of Indian Pharma companies promotes the allied industries of packaging to move beyond the value proposition of cost advantage, especially the rapidly evolving regulatory landscape. Indian companies are needed to conquer the challenges they are facing to get future ready to support the pharma players in their quest for growth. However, while the industry is in cognizance of the evolving regulatory and innovation landscape, the industry has yet to reach at their mark as far as technological development or adoption is concerned. Though the established players are adopting global trends, the momentum needs acceleration in context of fragmented nature of the market. Companies which can offer client reliability, along with obliging the regulatory norms, will be able to stand out from the crowd. Pharma Bio World

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Pharmaceutical Packaging â&#x20AC;&#x201C; an Overview Pharmaceutical packaging is very important for product identification, product protection, product usage facilitation, and product promotion. Basis the functionality, such packaging covers a huge array. Here the author has made a sincere endeavor to pen down various packaging system, which is of prime importance, in a very comprehensive manner.

ackaging is one of the most important touch-points in the entire pharmaceutical value chain. In addition to convenience, packaging greatly defines the functionality and efficacy of any pharmaceutical product. The delivery methods of pharma products may vary, but each method requires a robust and functional packaging solution that caters to not only the efficacy requirement of the medicinal drugs, but also assists the endconsumer in consuming it and bettering their health. Categorization: Pharmaceuticals can be categorized broadly into solid oral dosage, liquid oral dosage, and transdermal dosage. In terms of consumption, patients can intake these dosages either orally or by the way of suppositories. Most of these pharmaceutical drugs need moisture-barrier and/or oxygen-barrier as the drugs are susceptible to both. Thus besides acting as a dust-cover, packaging solutions contribute primarily in protecting these drugs from the detrimental effects of moisture and oxygen. Solid oral dosage packaging and thermoformability: Solid oral dosages are typically packed in two ways: either in thermoformed blister packaging or in bottles. The blister packs are usually made from thermoformable PVC, typically 200 to 250 microns thick. PVC is the most widely used material because of its easy availability, excellent thermoforming capability, and relatively low cost factor. Amorphous PET or APET which could also be about 200 microns

Anand Khare Consultant Design Thinking and Packaging Innovation 18 â&#x2014;&#x201E; August 2019

thick is used alternatively, although the range of usage is limited as compared to PVC. Polypropylene (PP) is another material of choice for blister packaging but has not gotten a whole lot of traction; because it needs a preheating zone on the thermoforming machine, is hard to thermoform, and is relatively expensive. For drug manufacturers who would like to stay away from PVC, PP or APET serves as an alternative. All these materials provide none to very little barrier to moisture or oxygen. Thus they are suitable to pack drug molecules that require little or no barrier. PVDC coated PVC: Many drugs would require a more robust thermoformable material, which would provide high to ultra-high level of oxygen and moisture barrier. A very popular solution is PVC coated with Polyvinylidene Chloride (PVDC). The coating comes in different levels such as 40, 60, 120, 150, 180, 240, and even 320 where the barrier increases exponentially as the thickness increases. The typical barrier for moisture ranges between 3.5 g/sq m/day down to 0.06 g/ sq m/day (at ICH conditions) going from mono PVC to highest level of PVDC coated PVC. Another variant which is available in the market is PVC/PE/PVDC, where in the additional layer of PE imparts certain flexibility to the structure and eases thermoformability. PCTFE Films: PVC can also be laminated with PCTFE films which provide excellent barrier to moisture. PCTFE does not provide any barrier to oxygen though. The PCTFE

Further to act as a dust-cover, packaging solutions contribute primarily in protecting the drugs from the detrimental effects of moisture and oxygen. Pharma Bio World

films are typically available between 15 micron to 152 micron, and when laminated with PVC can provide moisture barrier is as low as 0.03 g/sq m/day. Cold form foils: Cold form foils, which typically have a structure of BOPA/AL/ PVC, provide the highest level of both oxygen and moisture barrier. Bottle Packaging: While blister packaging is very common in Europe, India, and Asian countries, solid oral dosages in the United States are predominantly packed in bottles. The bottles carry large amounts of dosages and include a desiccant pouch to absorb any moisture in the head space. The closures are typically lined with different types of induction sealable liners which provide a very good hermetic seal. Child Resistant Packaging: Pharmaceutical packaging also comes in child resistant and senior friendly versions in blister packaging and bottles. The idea here is to ensure that the children have controlled access to pharmaceutical drugs and at the same time the package is easy to open for seniors. Liquid Oral Dosage Packaging: Liquid oral dosages are packed in bottles or even mono or unit dose packs. The unit dose packs are made of PVC/PVDC/PE layers where the PE provides a permanent seal and PVDC provides a good barrier. There are certain medicines that need to be administered through other side of human food tract and are called suppositories. These are packed in PVC/PVDC/PE or PVC/PE where the PE layer provides a good seal and at the same time is easy to peel for quick administration. Especially in countries like the United States, small pouches made of barrier

The idea of child resistant packaging is to ensure that the children have controlled access to pharmaceutical drugs and at the same time the package is easy to open for seniors. flexible material such as PET/EVOH/PE are becoming very popular as it gives the patients the convenience of taking one or two tablets, is easy to carry, and is rightly priced for a small dosage. Overt and Covert Anti-counterfeit Features: There are many overt and covert anti-counterfeit features that are being built into pharma packaging to prevent or reduce counterfeiting, diversion of supplies, reduction in profitability, and most importantly to protect patient health. Some of the overt features include holograms, 3D printing, micro text, printing with color shifting inks. Some of the covert features include micro taggants that can be detected by infrared pens. Compliance Packaging: Compliance packaging is another type that has seen tremendous growth in last few years and will grow even more as drug manufacturers. Hospitals and doctors try to ensure that patients take their medicine on time and also take right amount of dosage. Blister packs are gaining more prominence in this area. These packs are printed with either the date or month on back of each individual dosage to assist patients to take their medicine on time; or multiple drugs – either in tablet form or capsule form – could be packed in one blister unit to ensure all medicines are taken at the same time. Active and Intelligent Packaging: Active and intelligent packaging is also gaining its ground. Patients are now able to and

While functionality and aesthetics in pharma packaging is important, the solutions meeting global regulatory requirements such as FDA and EC/EU are also of paramount importance. 20 ◄ August 2019

would eventually be able to even more than just scanning the printed bar code or QR code on the blister packs with their smart phones; and would come to know about the drug’s use, its manufacturing date, its expiration date, and also the side effects. Going forward it is also quite possible where a notification will be sent to patient’s health records as soon as the patient purchases the medicine for him and as soon as he scans the pack. The blister packs or the bottles would need to have a track and trace mechanism which would enable the drug manufacturers to track the medicine throughout the entire supply chain till it reaches the end-consumer. This is already being implemented in some countries at different levels and would soon be a worldwide requirement. Global Regulatory Requirement in Packaging: While functionality and aesthetics in pharma packaging is important, the solutions meeting global regulatory requirements such as FDA and EC/EU are also of paramount importance. The packaging solution has to also pass toxicity studies. In fact without these compliances, none of the packaging solutions would be feasible options. Typically, for any pharmaceutical packaging solution to get approved, it takes 3 to 6 months, during which stability trials are conducted. Thus, it is very important that pharmaceutical drug manufacturers look critically at the offered solutions to ensure that not much time is lost in the approval process doing trials and errors.

Contact: kharea@hotmail.com Pharma Bio World

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Performance of Aluminium Based Packaging Materials Related to the Structure

Dr. E. Pasbrig GM Development and Technology ACG Pharmapack

old form laminate in India normally has aluminium thickness of 50 µm. Internationally, 45 µm is used

for packaging of standard products. If a higher dent resistant of cavity is needed, the thickness of aluminium will be 60 µm. Difference of 5 µm in thickness does not provide a better dent resistant, as shown in next table.

Aluminium thickness (µm)

1 reel (20 kg) in m2

84.4

79.8

Running meter (width 200 mm) 422

399

2 blister/cycle

844

798

2 lac blister (1320 sqm) (kg) 313

331

Saving (kg)

CFF

Stifness (Nmm)

25-45-60

1.13

25-50-60

1.14

40 cycle/min, blister 120 x 55 mm

25-60-60

2.12

Possible savings over a year, depending how many shifts per day are done, are in the range of ` 22 to 89 Lakh.

oPA-Al-PVC Formability of the laminate with 50 µm aluminium is not increased compared to the standard laminate with 45 µm Al. Use of laminate with 60 mm aluminium provides a slightly better formability and more consistent forming results related to pinholes (higher cost). Reduction of aluminium thickness by 5 µm for a cold form blister with dimension of 120 x 55 mm results in 18 kg material saving for packing 2 Lakh of blister. 22 ◄ August 2019

Approximately Saving (INR) 6311

INR (Lakh)

1 shift/day

6552

22.3

2 shifts/day

13104

44.6

4 shifts/day

26208

89.2

The example is showing, that CFF with 50 µm does not have an advantage in performance, needed higher amount of material by area and more frequent changes of reels during production.

Lid Foil, Aluminium Thickness 25 µm and 20 µm Similar result we get for the change of 25 µm to 20 µm aluminium thickness for lid foil. Beside the USA market, all other countries use a thickness of 20 µm, and Japan uses even 3 µm less. For aluminium foil p r o d u c e d in Europe, the max imum a mo u n t o f pinholes per m 2 with 0 .5 , r e s p e c tiv e 0.4 for 25 µ m are s imila r a n d d o n o t influenc e the barrier pr o p e r tie s o f th e s ealed blis ter. Savings of material for the lid foil, as mentioned in the following table, are up to 21.8 per cent. Al

HSL Lacquer wgt.

Yield

Saving 21.80%

54.0

62.0

16.1

67.5

75.5

13.2

For a production of blister (60 x 95 mm; 4 blister/cycle; 40 cycle/min; weight of reel = 14 kg) switching from 25 to 20 µm, produces 7040 blisters more, with 20 µm foil. In addition, time until reel needs to be changed is increased by 44 min. Pharma Bio World

Figure 1: Performance of Aluminium Based Packaging Materials Related to the Structure difference between the 20 and 25 µm foil used for converting.

Cycle per reel (14 kg) Thickness (µm)

14 kg = m2

225.8

185.4

Cycle/14 kg

9956

8176

Running time per reel Thickness (µm)

Production time (min)

249

205

Difference (min)

Related to seal strength, heat resistance, abrasion of printing ink, there is no Pharma Bio World

Burst pressure is increasing with the thickness of the foil. With this push through, force is increasing too. It is difficult to push a hart gelatine capsule through 25 µm foil without denting/ pressing the capsule. Reduction of Packaging Material Strip Pack – CFF – Tropical Blister Moisture sensitive products packed in strip pack are well protected as in CFF. If sealing layer of CFF has to be identical as

strip pack, LDPE or HDPE can be used. As sealing layer of lid foil an extrusion coating of LDPE on 20 µm aluminium is used. Comparison of strip pack and CFF highlights the main points as; • more packaging material has to be used. • product is in direct contact with sealing roller (hard gelatine capsule can stick on PE) and temperature sensitive products cannot be packed. Calculations to compare size of pack have shown, that with usage of CFF, 30 percent to 70 percent reduction is possible, depending on product geometry. If tropical blister is used, August 2019 ► 23

further saving is possible. Reduction in size is not identical with saving of cost. But if all points are taken, every example shows savings: • production time and output • lower weight • smaller folding carton • more blister in shipper • lower cost for logistics These calculations come into play if a customer expresses an interest to switch from strip pack to CFF or tropical blister. Lid PE Sealing layer of lid foil (push through) for sealing to CFF with polyethylene (LDPE, HDPE, CFF with desiccant) is produced by extrusion coating. To get sufficient adhesion to the aluminium surface a primer (lacquer) is

used between aluminium and PE. Because of this sealing, the layer related to lid foil is double in thickness compared with lacquer of 7 g/m2 where double amount of humidity and oxygen is migrating through it into the cavity. We were able to develop a push through foil with a lacquer in sealing to polyethylene with 5 or 7 g/m2, depending on customer requests. Not only is the cost less, but more importantly, the cross migration is reduced by 50 per cent. This lid foil is on the market already and replacing the material with extruded LDPE. Summary • Use of CFF with aluminium of 50 µm compared with 45 µm does not have any advantage related to performance; cost is higher related to area.

• Switching of lid foil with 25 µm aluminium to 20 µm provides an advantage related to cost and change time of a reel. • Change from strip pack to CFF can reduce pack size by 30 – 70 per cent. • Lid foil for sealing to polyethylene with a lacquer can replace the currently used lid foil with LDPE extrusion coating. It provides cost advantage and better barrier related to cross diffusion of a CFF blister. • If barrier layer of thermo form ﬁlms are on inner side barrier properties after forming is increased by 11 – 15 per cent. • ACG Pharmapack is offering a unique service to the pharmaceutical industry related to thermo forming, cold forming and sealing.

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Pharma Bio World

Serialization: Coding and Marking is Paramount to Readiness This article looks at the key role coding and marking systems play in serialization and how best to achieve consistent, reliable results in order to achieve compliance with ever stringent regulations

ith serialization deadlines fast approaching, a staggering amount of pharmaceutical manufacturers and contract packagers are not fully prepared to meet the stringent requirements for compliance. A number of reports have been commissioned to identify the extent of this issue, with the consensus being reached that some 30 to 40 per cent of European pharma companies are not compliant with the Falsified Medicines Directive (FMD) and some 50 to 60 per cent of US companies not compliant with the Drug Supply Chain Security Act (DSCSA). This begs the question: why are approximately one third of companies not ready for these major legislative changes? There are a number of reasons, not least the fact that implementing serialization is a complex cross-functional project. Many departments must coordinate effectively, from production, IT and Marketing to Engineering and Quality, and often a steering committee is required to coordinate activities. To implement such a major change over several lines, or in many instances across multiple plants, is a slow process. This has been exacerbated by end users requesting help from track and trace providers with increasingly short deadlines - creating a bottleneck for the skilled resources available.

Thierry Protas Global Pharma Director Videojet Technologies Pharma Bio World

This does not mean that pharmaceutical manufacturers should stand still on the issue, as there are many elements that can be addressed that must be implemented regardless. One critical aspect that can be considered and implemented ahead of time is the way in which products are coded and marked on the production line - an operational aspect on which effective serialization hinges.

Coding and Marking is Essential Given the complexity of a serialization project, coding and marking solutions can sometimes be assumed to be a minor player on the stage. However, although printing operations may appear on the surface to be a simple element, they are crucial to the success of a serialization project. Without a camera-readable code, all further process steps cannot be carried out and therefore serialization fails. If a printer is not capable of producing camera-readable serialization codes reliably, invalid printed packages need be reworked manually or, worse, codes become unreadable at some point along the supply chain and the invalid packages are not allowed to be released to the market. This can have harmful consequences for patients' health and can lead to costly losses in terms of sales revenue. Proven code quality is therefore the cornerstone of every successful serialization project. In the case of prescription drugs that fall under serialization legislation, the vast majority are packaged using folding cartons. This means that companies looking for effective coding and marking solutions must find the optimum combination of coder to carton substrate in order to achieve high quality, consistently readable codes.

Achieving the Ultimate Combination of Code to Carton With countless variations of folding cartons available, manufacturers and contract packagers seldom use the same packaging across the board. Code quality, therefore, is mutually dependent on the coding technology, ink type and August 2019 â&#x2013;ş 25

carton type. Through the identification of challenges faced by the market and the reaction of experts with practical solutions, it is now possible for pharmaceutical companies to take advantage of a joint service provided by Videojet and an independent foundation that effectively ensures the best possible combination of code to carton. This can significantly reduce the risk of issues deriving from inferior code quality, such as scanning issues and ultimately wastage as a result.

Connectivity and Data Management

A number of factors can influence the longevity of a code, depending on how that code has been applied to the packaging material. In the pharmaceutical industry, thermal inkjet (TIJ) or laser technologies are often preferred for code application. Laser technology provides fast permanent marks that are ideal for high throughput applications. They use virtually no consumables and offer very high uptime advantages. Thermal inkjet (TIJ) is by far the most common application in the pharmaceutical industry. It is easy to implement and maintain and offers superior print quality with clean, no-mess operation, and solidstate electronics requiring no controller maintenance. TIJ printers allow for more complex coding options and the ability to print linear bar codes, alternate fonts, logos, and 2-dimensional codes such as GS1 DataMatrix and QR codes.

Asynchronous communications is a good example of intelligent data management and how coding and marking systems can integrate with the flow of information. Advanced software allows the printer to send unsolicited information to the line control system, providing the dual benefits of active notification of a printer event and reduced network traffic. As a result, faster notifications can be achieved, which increases potential throughput on the line.

When evaluating code clarity, it is critical to assess the resistance of colors under the influence of light - particularly sunlight with high UV levels, and also how codes cope with abrasion - either on production lines, in transit or in the pharmacy store itself. Water resistance too is a key element, as condensation can often form in pharmaceutical manufacturing environments, particularly in cold chains. All of these elements can be stringently tested under laboratory conditions to ensure the best possible combination is recommended in terms of coder technology and inks if required. 26 â&#x2014;&#x201E; August 2019

The way in which a system interacts with the production line must also be taken firmly into consideration, alongside the need for that system to be easy to integrate and to handle serialization data effectively. The ability to purchase and implement serialization-ready solutions makes this a very straightforward process where coding and marking is concerned, and the benefits are wide ranging.

Buffer management, too, is a key area of consideration. Serialization solutions vary in their requirements for printer memory, therefore printers must be configurable to print unbuffered where variable data is received and printed one record at a time - and buffered, where many records are sent to the printer at once but printed only once each. When using a buffer, an unexpected line stoppage can result in unused codes unless an intelligent coding device can communicate which numbers are still available for use. This is especially relevant in countries where manufacturers may have to purchase serial numbers, enabling manufacturers to reclaim unused codes and ultimately safeguard against wastage. Finally, by utilizing Unicode encoding technology, over 1m characters can be encoded, unlocking access to a huge range of global languages. This is vital as, given the global markets served by the

pharmaceutical industry, manufacturers need to have the capability to represent an extensive number of characters across Arabic, Cyrillic, and pan-Asian languages. In all instances, ensure your coding and marking provider is able to offer full Installation Qualification (IQ) and Operational Qualification (OQ) packages. This will guarantee that the systems installed are not only set up according to your specific parameters, but are also able to deliver what is expected on an operational level. Working with Expert Partners Pharmaceutical companies who align themselves with an expert coding and marking provider can often reap the benefits of the relationships that company has with OEMs and Track & Trace providers. As coding and marking is such an integral element of serialization, there is often a reliance on these suppliers for the successful completion of projects, therefore certain elements of a project can sometimes be expedited. Videojet, through its commitment to its customers and ongoing relationships, constantly supports its partners to help them through the implementation phase, bringing to the table elements such as the testing facility for code assurance and other elements of advanced technical support. In addition, given the broad reach of pharmaceutical companies and their often global operations, the company's pharmaceutical experts - whether they be sales engineers or technical support specialists - are available worldwide to cover international serialization projects. Pharmaceutical companies do not have a choice where compliance is concerned outside of losing business as a result of lack of preparedness. Take steps today, engage with expert partners, and reap the rewards through operational preparedness.

Pharma Bio World

Simplicity or Specialism? Organizational Options for Global Labeling Functions Labeling is changing. The focus is expanding from a set of compliance-centric activities i.e. ensuring that product labeling complies with local and regional regulations and medical practices, towards a more patient-centric one i.e. ensuring that patients and prescribers receive, through both printed and electronic media, accurate and up-to-date benefit-risk information in a timely manner in order to make informed decisions about their treatment choices. As a result, labeling functions within the Pharma companies need to adapt in order to meet this objective. This article explores organization options both at the function level as well as the corporate level, and the key success factors for industry in their pursuance of labeling excellence

ne of the key challenges for the pharmaceutical industry is the need for accurate and timely communications of benefit-risk information about medicinal products between marketing authorization holders (MAH), regulatory agencies, healthcare professionals (HCP), and ultimately patients. Whilst this is a highly regulated area, it is also mired in complexities due to different and sometimes conflicting local and regional regulatory requirements, as well as variations in medical and business practices globally. Against this backdrop, pharmaceutical labeling, defined as the documentation and communication of approved prescriber and patient information to the end users, be they conducted via printed or electronic channels, is increasingly under the spotlight as one of the key communication and risk mitigation means to ensure the safe, effective and informed use of medicinal products in markets worldwide. The triple goals for a global labeling function: compliance, operational efficiency, adding patient and strategic value

Denis Fung Co-founder and Lead of Labelnet Navitas Life Sciences

Louise Tan Pharmacovigilance Subject Matter Expert Navitas Life Sciences Pharma Bio World

Navitas Life Sciences, together with labelnet, an industry professional network dedicated to pharmaceutical labeling, pioneered the concept of End-to-End (E2E) labeling over 6 years ago. The underlying principle for E2E Labeling is to approach labeling holistically, "from signal to patient", without being bound by artificial barriers such as functional silos which commonly exist in the Pharma industry, in order to ensure that, overall, pharmaceutical labeling is: 1. Compliant with global regulatory requirements, in terms of process and governance, to deliver accurate

and timely product information to the end-users, with the MAH having the ability to maintain oversight across its global network of affiliates and partners, and be inspection-ready in all the jurisdictions it operates 2. Operationally efficient, through deployment of fit-for purpose and scalable technologies to manage complex, cross-functional workflow and data which is generated across the E2E labeling journey. It also involves leveraging sourcing, distribution and other partner organizations as appropriate for efficiency gains and improved scalability 3. Value-adding, to create a more positive and patient-centric experience for the end-users, at the same time create greater strategic value for the corporate organization, be more outcomes-focused and providing timely strategic input particularly in early phases of product development (R&D) How can this be achieved? Since its inception, the labelnet community has been sharing insights and learnings in order to build a set of industry best practices in key topics such as compliant E2E process design, cross-functional teams and governance models to facilitate collaboration, and the use of technologies to manage the plethora of labeling content (eg, Core Datasheets, Reference Safety Information, Prescriber Information, Patient Information, Artwork, Packaging, education and other non-promotional materials, in both printed and electronic media), manage the complex cross-functional workflow (across Clinical Development, Pharmacovigilance, CMC, Regulatory August 2019 â&#x2013;ş 27

Figure 1: Business objectives for a labeling organization are expanding: from operational to strategic

Affairs, Medical, Commercial, Quality and Supply Chain), and to track and report on labeling change status, compliance metrics and performance indicators. An increasing focus is to ensure that organizational models, both at the labeling department level and at the enterprise level, are fit-for-purpose and designed to support the triple aim of compliance, operational efficiency and adding patient and strategic value as described earlier. Labeling organizational design - Key considerations What needs to change for a Global Labeling Function? When it comes to organizational design, achieving both elegance of simplicity and sufficient depth of specialism has always been a seemingly impossible balancing act. Finding the optimal structure which is best fit for an individual company requires effort and often some degree of experimentation, as it is influenced by the overall size of the company, its product portfolio, as well as its R&D pipeline, the nature, mix and 28 â&#x2014;&#x201E; August 2019

maturity of its products which could include new chemical entities, new biologics, generics, biosimilars, medical devices, combination products, across both prescription and consumer product categories. Higher level corporate strategies and organizational structure (eg, centralized vs. decentralized corporate models, geographic spread, and partnership models), company culture (eg, established large Pharma's vs. emerging Biotech's, Headquarter location and culture), and history of M&A (previous organizational models, ways of working from legacy companies) will also have an influence of the relative effectiveness of a given model. In short, there is no 'one size fits all' model. Labeling organizational Emerging options

design

Despite the statement above, there are clear trends in the types of design that are suited to certain types of companies, with each design having its own pros and cons. Over the past few years, we have

observed 4 common models for a Global Labeling function, with the following high level structures: 1. 'The One-Stop shop' 2. 2 sub-functions: Labeling Strategy and Labeling Operations 3. 3 sub-functions: Labeling Strategy , Labeling Operations and Labeling Compliance 4. 4-subfunctions: : Labeling Strategy ,Labeling Operations, Labeling Compliance and Regional Liaison The One-Stop shop This model is one in which the bulk of labeling activities are being performed by a generalist labeling professional role. By deploying generalists which look after the creation and maintenance of labeling content and labeling strategy, as well as other operational labeling activities, this model places emphasis on overall ownership and E2E focus, in both content and process, over pure operational efficiency. As such, this type Pharma Bio World

Figure 2: Common organizational models for global labeling functions

of model suits smaller organizations with fewer products, or products which require dedicated resource due to their nature or complexity, for example highly innovative molecules with complex profiles (and hence intimate knowledge about the product characteristics) for multiple indications. From an E2E labeling perspective, this model achieves good oversight on a product-by-product basis. As there are often global labeling leads per product, this also provides good visibility across regions and affiliates. However, this model can lead to inconsistencies in approach between different products or across therapy areas. It also places emphasis on individual ownership and to some extent, tacit knowledge of key individuals around the labeling histories of specific products, so it may be less scalable for large organizations, particularly those with a high staff turnover. The Labeling Strategy and Operations Model This model is characterized by two core sub-functions within Global Labeling, with Pharma Bio World

separate resources for labeling contentstrategy and for labeling operational activities, in order to provide a balance between depth of specialism without too many hand-offs. It is common in mid-sized Pharma companies with a moderate sized product portfolio, and suits products of low to medium labeling

complexity.

possible

challenge with this model is that it can create a segregation of knowledge and competencies and possibly reduced opportunities for personal development. On the other hand, it might suit individuals with a preference for specialism, as the roles are more focused and less generalist than the one-stop shop model. However, one potential misconception which may need to be guarded is that that contributions of a labeling professional engaged in 'operational' activities are less valued than those of a labeling 'strategist'. This needs to be managed to avoid an impact of overall staff motivation.

The Labeling Strategy, Operations and Compliance Model The addition of a third sub-function focussed on E2E labeling compliance addresses the emphasis to maintain and demonstrate oversight through E2E tracking of labeling updates, compliance metrics and performance KPIs. The labeling compliance subfunction maintains strong links between internal functions, including Clinical Development, Pharmacovigilance, CMC, Regulatory Affairs, Medical, Commercial, Quality and Supply Chain, with particular emphasis on labeling implementation i.e. implementing up-to-date and accurate labeling information into pack as well as online and other electronic media. While the original focus for many labeling compliance sub-functions was on E2E labeling process adherence, data governance and inspection readiness, labeling content alignment between regional / local labeling content, artwork August 2019 â&#x2013;ş 29

and packaging, with the core datasheets (CCDS) and other source documents, is increasingly coming under the spotlight and becoming part of the remit of many labeling compliance sub-functions. One of the main benefits of this model is having a designated E2E compliance owner, focussing on compliance through clearly defined metrics and KPIs. The model appears to be more common in larger organisations, particularly companies with a highly decentralized global network of LOCs (affiliates, partners, regional hubs), where achieving E2E labeling oversight is typically more challenging than for a centralized organization. In a similar but more exaggerated way to the previous model, the depth of specialism and separation between each sub-function are further increased, and the same potential risks e.g. segregation of competencies, perceived reduction in personal

development opportunities, and perceived difference in the relative importance of the different roles, need to be managed for this model to succeed. The Labeling Strategy, Operations and Compliance, with Regional Liaison Lastly, this 4 sub-function model with the addition of a sub-function focusing on regional coordination and liaison, pays particular attention to the importance of connecting with LOCs who are responsible for a variety of tasks including: local/regional label creation, update and maintenance, translations, preparation of Health Authority submissions and managing the Health Authority negotiations and relationships. This tends to be the model adopted by larger organisations with a greater need for focussed regional liaison. Getting the balance right between the need to

support LOCs in labeling management and providing an appropriate degree of empowerment and freedom to operate with local labeling ownership is challenging but can facilitate better management of local activities, better collaboration, as well as global consistency and oversight. A trend towards specialism? Among the Navitas labelnet members, it has been observed that the 3 and 4 subfunction models appear to be the more common choices among the larger sized companies (who typically have higher number of FTEs within their global labeling functions), whereas smaller companies with typically narrower product portfolios tend to favour the simpler models, In other words, as companies grow and expand, their global labeling functions have a tendency to favour more specialism, often driven by the need for efficiency gains

Figure 3: Effective End-to-End labeling is more than just process: Fit-for-purpose organisation design, as well as robust E2E governance are critical for success 30 â&#x2014;&#x201E; August 2019

Pharma Bio World

(through economies of scale), the need for the business processes to become more scalable in order to deal with higher volumes of workload, and the need for consistency in both process and quality across larger product portfolios.

the role becomes less compartmentalized and much more collaborative in nature because of the E2E scope. The profile of an effective and successful labeling professional will evolve with the evolving labeling organizational models of the future

Roles and responsibilities also tend to be more clearly delineated as the number of Conclusion FTEs within a labeling function increases. Once companies establish robust Pharmaceutical companies are under processes for compliance and efficiency, increasing scrutiny from regulatory focus can then be shifted to the more agencies to demonstrate that their products' strategic roles of labeling, which tends to go hand in hand with further specialism benefits outweigh their risks. In the past, the cascade of information from the and the creation ofADVERTISE additional sub-functions TO EXPAND identification of a safety signal to informing within global labeling functions.your reach through the patients and prescribers, was relatively Regardless of organizational model, we disjointed, lengthy and ineffective, with observe that there is also an increasing each internal function working to their own need for labeling professionals to procedures and metrics and far less crosspossess good leadership capabilities, functional coordination or clearly defined stakeholder management skills, and end-to-end timelines than we have today. project management competencies, as However, with the recognition and

embedding of the E2E labeling concept in more and more companies, our industry is changing. The focus is expanding from a set of compliance-centric activities i.e. ensuring that product labeling complies with local and regional regulations and medical practices, towards a more patientcentric objective i.e. ensuring that patients and prescribers receive, through both printed and electronic media, accurate and up-to-date benefit-risk information in a timely manner in order to make informed decisions about their treatment choices. Whilst there is no "one size fits all" organisation model for global labeling functions, investment in time and effort in the design and optimization of the labeling organization model will be a significant contributor for success in delivering E2E labeling in a compliant, efficient, and a high value-adding way.

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August 2019 â&#x2013;ş 31

Journey of SyMetric: an End-to-End Solution Provider in Clinical Trial The article narrates the journey of a start-up venture SyMetric. The co-owner has penned down her experience about the entire expedition starting from conceptualization, to sailing through trying times, establishing the first foot-hold, and the way forward.

Conceptualization of the Start-up: Concept is an idea that wallops out of a circumstance, takes shape of a dream, becomes a passion and, in turn, the way of life. Choosing Life-science industry was comparatively an easy deal for me as I had a close association with the CRO-s and Doctors over a longhaul. In 2011, I and my partner were at the crossroads of our career, both with long-drawn-out experience in our own domain and with a fiery impetus to do something significantly impactful. Coming up with an end-to-end software solution for clinical research on a single database was the concept for us. I, personally, made my mission to sell the idea to the pharmaceutical companies who needed a direct real time view, as well as a control on their trial conduct to reduce the CRO-dependency. The concept was to enable quick decision making on IP management on the fly in conduct phase, which in turn leads to substantial cost reduction, efficiency increment, and faster trial completion. Objective setting and establishing our foot-hold: We were no-one in the industry at the beginning. The Lifescience domain seeks an extraordinary skill to bring both mathematics and biology together. Converting the medical concepts and processes into algorithm, process automation, and software coding indeed was a great adventure. Once the concept was matured to a concrete decision, the next steps were to

Uma Janapareddy Founder and Managing Director SyMetric 32 â&#x2014;&#x201E; August 2019

meet the domain experts to understand the process-flows and then to convert them to design-documents. It was clear that we were filling in the void of an integrated solution on a single database. There was no significant peer-venture existed in the market when we started seven years ago. The software solutions available were either rudimentary or very expensive. Our venture â&#x20AC;&#x201C; SyMetric â&#x20AC;&#x201C; had set out to address the both to bring in a robust yet cost effective, intuitive, and simple ERP solution. Moving into scuffle and complexity: Initially, putting the team together happened as a cosmic conspiracy; and things just fell in place without much effort. The design-document was ready in less than the anticipated time. The first version of the product was ready within next 8 months. Everything was seemingly smooth at that time with bootstrapped investment, even though building a software solution is never ever a comfortable journey. Things usually go pretty well when all activities are under control. Vouched by all entrepreneurs the challenge shows up when the rubber hits the road. Well, we can only control the wheels and NOT the road. The challenge came in roaring when we began our marketing and sales initiatives. For a business to make inroads to a highly conservative as well as regulatoryand-quality driven zone, which is again heavily influenced with data security and confidentiality, is always something

Coming up with an end-to-end software solution for clinical research on a single database was the concept for us. Our venture, SyMetric, had set out to bring in a robust yet cost effective, intuitive, and simple ERP solution. Pharma Bio World

enormous. Coming from an NGO background, I had no known name in the industry with me who could rally behind and endorse our business as well as our product. It was the TRUST we needed to build with the customers at the initial phase and made them believe that we can be relied upon with the data and their trials. We had to cope up with many questions viz are you a techie, who is your SME (subject matter expert), has anyone used your products so far, etc. We were into this situation for almost two years with enumerable cold calls, mails, and demos without any opportunity to sign the dotted line. We exhausted our seed fund and reached a point where pumping more funds in was not an option anymore. We gave ourselves one more month to wind up if we do not get a project by that time. It just took that ONE CRO/ Pharma Company who took the leap of faith and gave us our first project at that time, which is during the second year of our business; and till date they have been with us as our loyal customer. Team development – next step towards growth: To make a provision for growth, the next step due was to strengthen and to expand our team. However, the chance for talent acquisition was very remote until our business-finance got a boost through investors’ funding; and we intentionally chose not to invite any investors as we felt that could dilute our passion and purpose. We decided for an out-of-the-box recruitment strategy to address our talent acquisition need. We wanted to appoint skilled resources enabled with multi-tasking aptitude and adaptability, with an OPEN ATTITUDE to learn, unlearn, and relearn. This worked well for us; and facilitated in developing

The team, all of us knew failure, and how to pick up when we lost. We learnt endurance. We learnt failure is a part of the success journey. a team with requisite diversified skills.

wide-spread

Assessing the market readiness – the restraints and initiatives: Our venture, SyMetric, had built a futuristic product-suite that provides an endto-end solution for a clinical trial. However, the most crucial and topical question is: is the market ready to use this advanced technology? Are the endusers (personnel at the clinic) skilled and prepared enough? And unfortunately the answer has been – NOT YET. To dig deep, India’s technology adoption rate is usually way too slower than that of the US and the UK. Sometimes we had to soften the product features to meet the end-user’s skills and expectation. Any deep-seated change in its conventional process to amend the look and feel of the solution could lead to frustration and rejection. So, the challenge for us was to build a futuristic tool keeping the conventional methods almost intact. The disparity between the management’s willingness to adopt new technology and that of end-users to implement still persists as a huge gap due to variation in automation, and which is being filled in slowly and steadily. A shift in the Government policy is to bring about stringent regulatory guidelines to make clinical trials a more effective and transparent process. The Government of India’s thrust in ensuring patient safety, while encouraging modifications and easing out the processes at the same

The most crucial and topical question is: is the market ready to use this advanced technology? Are the end-users skilled and prepared enough? Pharma Bio World

time for conducting clinical trials, is a welcome move. We have been consulting with Center for Development for Advanced Computing (CDAC), Ministry of Health, Government of India on various products we can build in partnership – especially in patient safety area of clinical trials. Ideation for way forward: Almost every day we get a new idea in our mind on how to enhance the product, and how to make it user friendly as well as affordable. However, unfortunately, the market need and slower adoptability factor have been acting as the dampener. Initiatives: SyMetric, so far, has submitted eight FDA projects which were successfully approved and eventually implemented. The integrated IT platform with IWRS, EDC, built in CTMS, Medical Coding, and PV is now synonymous with the global products. In addition to this, SyMetric is now in partnership with SAP COIL to bring up a tool for PharmAnalytics; and also working on technology partnership with Microsoft. Conclusion: To sum up, the past 7 years were of perseverance and endurance that paved way for the success so far. This is only the beginning of a road to the global map. SyMetric plans to set up its operations in the USA and Europe in this Financial year.

Contact: uma@symetricsystems.com August 2019 ► 33

press release Firms Collaborate on Next Generation Pick and Place Delta Robotics

Ecublens, Switzerland: Pioneering Swiss robotics company Demaurex has signed a joint development agreement with Genesis Robotics and Motion Technologies to produce advanced components to boost packaging line robotics. Demaurex has been an industry leader for high speed pick and place robotics; and will integrate with Genesis Robotics’ LiveDrive Direct-Drive Moto into its latest generation Delta Robot Systems. Demaurex engineered and industrialised the original Delta robot in 1988, based on a patent of Reymond Clavel of the Ecole Polytechnique Federale de Lausanne (EPFL), introducing high speed, vision guided product pick and place systems to the robotics market for the first time. Demaurex has been operating in the food pharma packaging market for decades; its robots are moving items, less than 3kg in weight, quickly form one position to another. It also works in the consumer goods market – personal care, as well as bakery, produce, fresh meat, vegetables etc. The key area the company started in was confectionery, when one of its chief technology officers saw a 20kg robot picking and placing 20g chocolate packs. Genesis Robotics’ LiveDrive Direct Drive Motor is designed to improve performance, reduces maintenance, and increases up-time. The key feature of the technology is its reduced components size which improves the level of speed, torque, and precision on packing and packaging lines in various industries. Frank Souyris, General Manager at Demaurex, said: “The LiveDrive technology offers new levels of simplicity and ease of use, eliminating the need for costly, bulky and unhygienic gearboxes all in a much smaller envelope. This will result in reducing the total cost of ownership and promoting ease of use for our customers.” Most robots feature components, motors and gears adding up to around 500mm. The length of the live drive is less than 60mm. Roy Fraser, Vice President of Product at Genesis Robotics, told Packaging News: “This is one of the core unique selling points; it gets the robots much close which improves the robot density and subsequently the pick density. The LiveDrive produces lower inertia and lower mass and up to three times as much torque ratio. It means the motor can start and stop very fast – making it much more productive, efficient, and reliable.” Fraser explained that not only was the motor made smaller, the technology removed the gearbox too. He mentioned, “removing the gearbox means removing the risk of contamination, breakdown, and maintenance. Additionally, power consumption is lower.” James Klassen, inventor of LiveDrive, added that the collaboration between Demaurex is significant for Genesis because it demonstrates that the power density of the LiveDrive motor can help redefine the Delta Robot. “The platform itself is what the industry has been waiting for: a high torque actuator that delivers three times higher torque density, high peak torque capacity, and the highest levels of precision. Taking advantage of three 34 ◄ August 2019

foundational discoveries – Magnetic Amplification, Advanced Structural Magnetic Architecture, and unparalleled Heat Dissipation – the LiveDrive Direct-Drive motor provides manufacturers with the ability to design simpler, faster, and more precise robots and machines.” Chris Di Lello, Chief Executive of Genesis Robotics and Motion Technologies, added: “We are honoured to work with Demaurex SA as we believe that this collaboration demonstrates the powerful outcome that can be achieved when two companies with shared values, an intense desire to improve on the status-quo, and a deep respect for each other work together in true partnership.”

Roche and Spark Therapeutics, Inc. Announced Extension of Tender Offer

Basel, Switzerland; and Pennsylvania, United States: Roche and Spark Therapeutics, Inc. announced that Roche has extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock (the "Shares") of Spark for USD 114.50 per share, net to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law and upon the terms and subject to the conditions set forth in the offer to purchase dated March 7, 2019 (as it may be amended and supplemented from time to time, the "Offer"). Pursuant to the Agreement and Plan of Merger, dated as of February 22, 2019, by and among Roche Holdings Inc., 022019 Merger Subsidiary, Inc., and Spark (as amended, the "Merger Agreement"), the Offer, which was previously scheduled to expire at 5:00 p.m., New York City time, on Wednesday, July 31, 2019, has been extended until 5:00 p.m., New York City time, on Tuesday, September 3, 2019, unless it is extended further under the circumstances set forth in the Merger Agreement. All terms and conditions of the Offer shall remain unchanged during the extended period. The Offer was extended to provide additional time for the US Federal Trade Commission (the "FTC") and the UK Competition and Market Authority (the "CMA") to complete their previously disclosed reviews of Roche's pending acquisition of Spark. The parties remain committed to the transaction and are working cooperatively and expeditiously with the FTC and the CMA. Citibank, N.A., the depository for the Offer, has advised Roche that, as of 5:00 pm, New York City time, on July 30 2019, approximately 9,715,086 Shares of Spark (none of which were tendered by notice of guaranteed delivery) had been validly tendered and received, and not validly withdrawn, pursuant to the Offer, representing approximately 25.2 percent of Spark's outstanding Shares. Stockholders who have already tendered their Shares of Spark do not have to re-tender their Shares or take any other action as a result of the extension of the expiration date of the Offer. Closing of the tender offer is conditioned upon customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and there being validly tendered and received, and not validly withdrawn, a majority of the outstanding Spark Shares. McKenzie Partners Inc. is acting as information agent for the Offer. Pharma Bio World

press release Facing Headwinds in the US, Natco Pharma Looks to Scale Up its Business in China

Hyderabad, India: Natco Pharma is focusing on filing of cancer treatment drugs in China, the world's second largest pharmaceutical market, as part of its strategy to diversify its business in various emerging markets amid headwinds in the US. Addressing to the shareholders in the company's Annual Report for 2018-19, Natco Pharma Chairman and Managing Director V C Nannapaneni said the company had foreseen imminent headwinds in the US market and had begun diversifying its resources towards building businesses in new markets. Those investments are now reaping rewards, he added. "We are currently investing to further establish our presence in Australia, Singapore, China, and South East Asian countries; and are confident that our businesses in these markets will propel growth in the future", Nannapaneni said. In the near term, growth for the company would continue to be driven by markets viz India, Brazil, and Canada, he added. "As we continually balance our portfolio of products and growth in the US, we expect majority of revenue to be coming from non-US markets," Nannapaneni said. Commenting on the company's plans in the China market, he added that it is focusing on oncology product filing in the country. China is the second largest pharmaceutical market globally with total spending of USD 137 billion in 2018. Government reforms to improve insurance access and recent upgrades in the hospital and primary care infrastructure have led to increase in spending on healthcare initiatives. China's pharma market is likely to grow at 3-6 per cent to USD 140-170 billion by 2023 as against Brazil which is likely to grow at 5-8 per cent to USD 30-43 billion. Nannapaneni also said the drug firm has also begun exploratory work for expansion into Africa. "We believe that this will help us to diversify further into new geographies for growth", he said.

Maharashtra to Set Up Single Window Clearance System for Pharma Companies

Maharashtra, India: The Maharashtra Government is planning to attract pharmaceutical companies to set up base in the state and has decided to set up a single-window system to grant them clearances and address their grievances. Food and Drug Administration (FDA) Minister Jaykumar Rawal recently held meetings with representatives of the Indian Drug Manufacturing Association to understand why the pharma companies, for whom Maharashtra was earlier a preferred destination, shifted to Himachal Pradesh in recent years. Earlier, around 3,000 pharma companies had their manufacturing units in Maharashtra. But gradually, majority of them shifted to Himachal Pradesh due to various sops offered there, Rawal told reporters here during the weekend. "I found out during my meetings with the stakeholders that these companies face a big hurdle in getting environmental clearances. Pharma Bio World

The FDA will set up a single-window clearance system to help in this matter", he said. Rawal said there were plans to make Nagpur and Aurangabad as the Pharma Hubs in the state. In Nagpur, work is already in progress at MIHAN (Multi-modal International Cargo Hub and Airport at Nagpur), he noted. "The focus will be on production of Ayurvedic medicines. There are plans to make a pharma hub between Aurangabad and Nashik along the MumbaiNagpur Samruddhi Corridor. Plans are also afoot to set up a world class lab at the pharma hubs", the minister said. "We want to compete with China in the production of generic medicines", he further said. The Indian pharma products have a good response in Europe, he commented, adding that Bosnia is keen on a joint co-operation with Maharashtra in the pharma sector.

Herma to Present New Colour Print and Apply System for Personalised Packaging at FachPack 2019

Nuremberg, Germany: At FachPack 2019 from 24 - 26 September 2019 in Nuremberg, Germany, HERMA (hall 3A, booth 236) will present the new PA8 4C Print & Apply System, a solution break through that meets the demands of personalization, efficiency, and market demands while providing optimal color quality. The system, one of the first of its kind, allows for full-color, edgeto-edge print on white labels and the exact assignment of each completely individualized label to the respective packaging unit. Possible labeling types are top labeling as well as L- and C-shape labeling. The label applicator, which was especially developed for this system, ensures that only the last label printed is applied. Memjet VersaPass technology is used to manage the printing of the labels. “We choose Memjet for this solution because of its outstanding print quality”, says Ulrich Fischer, Head of Product Management at HERMA’s Labeling Machines Division. “In addition to image quality, the safety of the water-based ink is ideally suited for applications in the pharmaceutical or food industries.” Suitable labels for Memjet technology are available as paper or PP film versions with glossy or matt surfaces. Memjet’s integrated four color management system (CMYK) ensures that preset color accuracy for logos, and defined spot colors of a brand owner design, are achieved with precision regardless of the label material. “Packaging that has been individualized in that manner meets brand owner requirements and increase marketing effectiveness”, says Fischer. Just-in-time design: Ulrich Fischer pointed out, “As we are frequently talking about very small batch sizes in late stage customization, one will always have to consider for each case whether automated systems make economic sense.” Regarding packaging dimensions, the system is currently designed for sizes between 90 x 50 x 15 mm to 150 x 150 x 30 mm (L x W x H). Format sets are used to adapt the system to different packaging sizes. Label sizes can vary between 45 x 85 mm to 175 x 150 mm (W x L). “Combined with the possible labeling types, this gives users maximum design freedom”, added Martin Kühl, Head, Labeling Machines Division, HERMA. “The system allows them to design only the actually required packaging unit just in time, with no need to store many pre-printed folding cartons”. August 2019 ► 35

press release Eris Lifesciences and PlexusMD Joined Hands to Offer Saarthi Ahmedabad, Gujarat: Eris Lifesciences – a leading pharmaceutical company, and PlexusMD – India’s largest professional networking platform for doctors, have recently announced their partnership for a unique AIempowered learning platform named “Saarthi”. Through this endeavour, the companies aim to enable Indian physicians to stay connected with global developments and practise evidence-based medicine to improve patient health outcomes. Artificial intelligence (AI) empowered technology and machine learning can help tailor the content and adapt the pace of delivery to each practising physician’s unique learning needs for them to apply the insights more effectively in their practice. This app-based platform will be a one-stop destination to provide Continuing Medical Education (CME), medical content, medico-legal precedents, medical conference feeds, case discussions, etc. for physicians. “Saarthi” is an interactive, innovative, and relevant platform to simplify learning for doctors, who continuously face time-constraints in their attempt to keep abreast with latest developments in the medical field. With an artificial intelligence empowered technology, Saarthi will help doctors in their evidence-based practice as each patient case can be unique. A distinctive feature of the app is a calculator that will help doctors quickly arrive at the right dosages, drug combinations, and diagnostic criteria for commonly encountered situations. Highlighting the need for such an offering, Dr. Viraj Suvarna, President Medical, Eris Lifesciences Ltd. said: “This is a collaboration between two very exciting pioneers, one from the pharmaceutical space and the other from technology. This partnership is a step forward in a domain that requires deep learning but where time constraints become a major deterrent for doctors”. Elaborating on the partnership, Dr. Rohan Desai, Founder, PlexusMD, said: “E-learning is the reality in every domain, including medicine. Saarthi is a unique platform where an AI-empowered engine will deliver precise and customized content to the enrolled doctors depending on their interests and learning requirements. The app will address two critical issues in today’s time –information overload and fake news – to ensure doctors are provided with information relevant to them.” “Technology has made learning an enjoyable experience. The traditional learning that doctors were exposed to during their graduation and postgraduation days can now be made exciting with the use of technology. Doctors can learn from case studies using virtual and augmented reality”. Eris Lifesciences is focused on filling up the gaps in patient care: diagnostics, therapeutics and patient compliance. PlexusMD, an online professional network for medical professionals and healthcare organisations, is centered on professional growth of doctors.

LIVI Announced New NHS Partnership

United Kingdom: LIVI, the UK division of European digital healthcare provider KRY, has announced a collaboration with Northampton General Practice Alliance, Alliance for Better Care, as well as other partners across the South East for health partnership. 36 ◄ August 2019

The partnership aims to bring access to app-based video GP consultations for over 1.85 million NHS patients, enabling local GPs to also work on the platform helping to treat patients in their area digitally. The company is already operating in North-West Surrey, with the service available to over 360,000 patients. The service will now be extended to Birmingham, Shropshire, Northamptonshire, and parts of the South-East, as well as extending services to more practices in Surrey, meaning that LIVI will now offer services to 1.85 million patients. The partnerships come at a time of significant pressure for the UK’s Primary Care Networks, with the NHS struggling to recruit and retain doctors, particularly in crucial areas such as paediatrics. Video consultations have been cited as a way to take the strain off GPs, as well as offering them greater flexibility, support, and more meaningful work, since they can focus their time in the surgery on the patients who need it most. Luke Buhl-Nielsen, UK Country Manager of LIVI, said that the company’s mission is to improve access to primary care for every patient and it does so in a way that significantly relieves pressure on GP surgeries. He continued, “Our first partnership in North-West Surrey highlighted within the first six months of the positive impact that LIVI can have offering GPs greater workplace flexibility, decreasing attendance at A+E or Urgent Care Centres, while delivering excellent care for every patient. We’re excited to see the future impact of our new partnerships for both patients and care providers. NHS England’s recently published GP Patient Survey showed a sharp decline in the number of patients in North-West Surrey. It has been revealed that they would have attended A&E as an alternative to seeing a GP, revealing a 28 percent drop in the number of patients reporting that they went directly to A&E after being unable to get a suitable GP appointment in the year since August 2018.

Glenmark Pharma Received USFDA Nod for Cholesterol Lowering Drug Mumbai, India: Glenmark Pharmaceuticals has announced that it has received final approval from the US health regulator for Ezetimibe and Simvastatin tablets, used for treating high levels of cholesterol in the blood.

The approved product is a generic version of MSD International's Vytorin tablets. The approval has been granted by the United States Food and Drug Administration (USFDA) for Ezetimibe and Simvastatin tablets in the strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. Citing IQVIA sales data, Glenmark said Vytorin tablets' market achieved annual sales of approximately USD 92.4 million for the 12-month period ended April 2019. The company said its current portfolio consists of 157 products authorised for distribution in the US and 58 ANDAs pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.55 per cent higher at ` 450.80 apiece on BSE. Pharma Bio World

press release Bayer Acquired BlueRock in Cell Therapy Move

Leverkusen, Germany: Bayer AG has announced that it is to fully acquire BlueRock Therapeutics, a privately held US-headquartered biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology by using a proprietary induced pluripotent stem cell (iPSC) platform. The news comes following a 2016 joint venture with Versant Ventures to establish BlueRock Therapeutics, and Bayer will now acquire the remaining stake for approximately USD 240 million in cash to be paid upfront at closing, and an additional USD 360 million payable upon achievement of pre-defined development milestones. BlueRock Therapeutics’ portfolio of cell therapies is currently focused on neurology, cardiology, and immunology with a lead program in Parkinson’s disease expected to enter the clinic by the end of 2019. “The acquisition marks a major milestone on our path towards a leading position in cell therapy”, said Stefan Oelrich, member of the Board of Management, Bayer AG and President of Pharmaceuticals Division. “In line with our strategy to ramp up our investments in technologies with breakthrough innovation potential, we have decided to build our cell therapy pipeline based on BlueRock Therapeutics’ industry-leading iPSC platform. Ultimately, we are joining forces to deliver new treatment options for medical needs that are still unmet today.” After the acquisition, Bayer will own full rights to BlueRock Therapeutics’ CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities.

Kite Introduced New Indicators to its Temperature Sensitive Packaging Range Coventry, England: Employee-owned business, Kite Packaging, has released its new temperature indicators to help businesses accommodate a maintained temperature in transit. These new temperature indicators are small self-adhesive labels that go inside chilled packaging to facilitate contents that need to be kept at a certain temperature. They monitor the temperature throughout a specified time period and indicate when their maximum threshold has been breached. Each indicator also informs users about how long the contents have been above the specified threshold temperature. Temperature indicators are commonly used with many food, pharmaceuticals, and medical products to show the accumulated time-temperature history of a product. There are two specifications available: food temperature indicators and pharmaceutical temperature indicators, ranging from temperatures 5-8°C and have varied time frames. Each of Kite Packaging’s indicators are self-activated and will ensure chilled goods get to their destination at the desired temperature that businesses require. The temperature indicators are another addition for the business’s new chilled packaging range, which features enviro-friendly insulated Pharma Bio World

boxes, insulated box liners, ice packs, thermal pallet overs, and temperature controlled pouches.

Stempeutics, Kemwell in Joint Development and Marketing Pact for Stem-cell Products

Bengaluru, India: Bengaluru-based firms Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG) and Kemwell Biopharma have joined hands for global commercialisation of Stempeutics' stem cell product Stempeucel. Under the agreement announced on July 22, Kemwell will take a minority stake in Stempeutics and invest up to ` 95 crores based on certain milestones as well as establish a world class cGMP cell therapy manufacturing facility at Kemwell's facility in Bengaluru for contract manufacturing of cell therapy products. Currently Stempeutics is working on three key indications i.e. Critical Limb Ischemia (CLI), Osteoarthritis (OA), and Diabetic Foot Ulcer (DFU). For marketing the products in India, it has partnered with Cipla for the CLI indication and with Alkem Labs for OA indication. Stempeutics is now exploring registration and commercialisation of Stempeucel in developed markets. Funds received from Kemwell will be utilised for achieving key regulatory milestones in the US, Europe and Japan, as stated by the Company spokesperson. Commenting on the Kemwell collaboration, Ranjan Pai, Chairman, Manipal Education and Medical Group said, "We are progressing well towards our goal of bringing stem cell-based products for unmet medical needs in the Indian market by Yr 2020. Stempeutics has done pioneering work in stem cells R&D and by far, it is the first stem cell company in Asia to demonstrate significant clinical outcomes in CLI. The synergistic combinations of Kemwell and Stempeutics will accelerate the development of novel stem cell-based products for patients and will transform India into a global player in stem cell therapeutics." Anurag Bagaria, Chairman and CEO, Kemwell added, "We believe that Stem Cells will become a major branch of medical treatment and a standard of care for challenging diseases. Kemwell is looking forward to building a world-class cGMP facility in Bangalore and make India as an emerging hub for cell therapy manufacturing. We are happy to partner with Stempeutics because of their strength in developing innovative stemcell products starting from basic research, preclinical studies, large scale manufacturing, and conducting multi-centre clinical studies meeting international standards." Chandru Chawla, Executive Vice President - Cipla and Board Member, Stempeutics added: "Stempeutics has been at the cutting edge of stem cell research and remains among the top cell therapy companies in the world bringing therapeutic products for difficult-to-treat diseases. It has made Invent-in-India a reality". B N Manohar, CEO of Stempeutics said, "Our Company's mission is to develop innovative stemcell products addressing major unmet medical needs with an India first, global next approach. In the past 10 years, we have developed cutting-edge technology to bring stem cell products in India to physicians who now have an off-the-shelf stem cell therapy in their hand to fight diseases like Critical Limb Ischemia. With Kemwell's investments, we plan to register for additional indications for Stempeucel, expanded into the developed markets, and further to develop our pipeline." August 2019 ► 37

press release Cipla Re-enters Chinese Market in Joint Venture with Jiangsu Acebright Mumbai, India: Mumbai-based global pharmaceutical major Cipla has announced that it has entered the Chinese market in a joint venture with Jiangsu Acebright. Cipla will set up a manufacturing plant for respiratory products in China under the joint venture.

A combined total investment of USD 30 million will be made for the joint venture. Cipla EU, a wholly-owned subsidiary of Cipla, will hold an 80 percent stake and Acebright will hold a 20 percent stake. Even though Cipla will start off with respiratory products in China, the pharma company aims to expand to other segments in the future, according to Umang Vohra, MD & Global CEO of Cipla. "We are keen to take our well-established expertise in the respiratory segment to patients in China. Simultaneously, we will explore various routes to build a product portfolio in other therapeutic segments such as oncology", Vohra said. He also added that China would be an important part of their future roadmap. "While our core home markets remain our current growth anchors, we see China as a crucial part of our future roadmap. In May, we inaugurated our office in Shanghai. We have a long-standing relationship with Acebright, and this partnership to build a manufacturing facility in China is a significant step for us", he said. Meanwhile, Shengping Xu, Chairman of Acebright Group, said: "We have a long-standing partnership of more than 20 years with Cipla which shares our vision and approach towards patients. We are pleased to strengthen our relationship with Cipla through this joint venture and strongly believe the joint venture will bring more products to Chinese patients in the respiratory segment." This is not the first time Cipla has entered the Chinese market. In 2012, the pharma major held stakes in three different Chinese companies: 25 percent in Biomab, 48.2 percent in Jiangsu-based Cdymax and 16.6 percent in Shanghai Desano Pharmaceuticals. Cipla later rejigged its investments letting go of the stake in Biomab and Cdymax. It sold its stake in Jiangsu-based Cdymax in 2014 for USD 18.5 million. The share in Hong Kong-based Biomab was sold in 2015 to British Virgin Islands-based Biomab Brilliant for USD 25.8 million.

Cipla Profit Rises 6% to ` 478 Crore Mumbai, India: Drug maker Cipla has reported a net profit of ` 478.19 crores for April-June period. That marked an increase of 5.97 percent compared to the corresponding period a year ago. In a regulatory filing during market hours, Cipla said its revenue from operations grew 1.27 percent to Rs. 3,989.02 crores in the quarter ended June 30. The pharmaceuticals major had posted a revenue of Rs. 3,938.99 crores in the first quarter of financial year 2018-19. In a presentation to investors, the company said that despite significant global volatility and revenue deferrals, its profitability was maintained in the first quarter of the current financial year. 38 ◄ August 2019

The Mumbai-based drug-maker said its international sales grew 8 percent to Rs. 2,466 crores in the quarter. Its domestic sales however declined 8 percent to Rs. 1,429 crores. Its revenue from the pharmaceuticals business stood at Rs. 3,959.93 crore, marking a year-on-year increase of 1.22 percent. Its India operations contributed 34 percent to the total revenue while North America accounted for 28 percent, Cipla said in its presentation. The company said that its earnings before interest, taxes, depreciation, and amortisation (EBITDA) rose 25 percent on year to Rs. 905 crores in the April-June period. Shares in Cipla jumped as much as 4.97 percent during the session, before settling with a gain of 3.76 percent on the BSE after the earnings announcement, outperforming the benchmark Sensex index which fell 0.77 percent.

Vitafoods Asia Assists Companies to Develop their Nutraceutical Business Singapore: At Vitafoods Asia, buyers can source products that address core and new health areas, such as combating the effects of pollution by using an oral nutraceutical. Monteloeder is a returning exhibitor at Vitafoods Asia 2019. “Vitafoods Asia is a good platform to interact with customers from Southeast Asia,” said Ignacio Cartegna, Vice President of Sales, Monteloeder. “Our company develops branded ingredients that we sell in more than 40 countries”, added by Cartegna. He said that the main challenge is a “lack of resources and the disparity of legislation. If you want to develop something different, supported by clinical studies, that comply with the legislation, and that is capable of competing in the market you need resources.” In Asia, particularly in China, India, Korea, and Vietnam, pollution is a serious issue to which, Cartegna commented, Monteloeder are responding. “Exposure to air pollutants have been associated with premature skin ageing, dryness, acne, skin rashes, pigmentation problems, and wrinkles. Among all the pollutants, particle matters of more than 2.5 μm are especially dangerous as they penetrate deep the lung tissues and are linked to many diseases.” This year, at Vitafoods Asia, he said, “We are presenting Zero Pollution, which is the first oral ingredient to prevent and repair some of the damaging effects leading to pollution exposure, especially on the skin. So, it is a skin product.” To help companies like Monteloeder, Vitafoods Asia provides solutions for entities of any size to build a nutraceutical business in Asia. Visitors to Vitafoods Asia can leverage the exhibition and conference to source ingredients and raw materials, to meet with contract manufacturers, to source branded finished products, to discover packaging options, or to source services that help to address research, marketing, packaging, product development, or regulatory issues. Pharma Bio World

press release Study Shows Personal Digital Devices may Help in the Identification of Mild Cognitive Impairment, Mild Alzheimer’s Disease Dementia Indianapolis and San Mateo, United States: Initial results from a feasibility study conducted by Eli Lilly and Company, Evidation Health, and Apple Inc. showed that an iPhone, Apple Watch, iPad and the Beddit sleep monitoring device, in combination with digital apps may be able to differentiate people with mild cognitive impairment (MCI) and mild Alzheimer's disease dementia. The exploratory results were presented at the Association for Computing Machinery's KDD conference in Anchorage, and are published on the conference website as one of the top papers of the conference. "Over the past few years, we've seen how data and insights derived from wearables and mobile consumer devices have enabled people living with health conditions, along with their clinicians, to better monitor their health," said Nikki Marinsek, PhD, a first author and data scientist at Evidation Health. "We know that insights from smart devices and digital applications can lead to improved health outcomes, but we don't yet know how those resources can be used to identify and accelerate diagnoses. The results of the trial set the groundwork for future research that may be able to help identify people with neurodegenerative conditions earlier than ever before." "Lilly has been leading the fight against Alzheimer's disease for more than 30 years, and we're broadening the application of digital health to identify tools that may improve the lives of people with chronic conditions and diseases", said Divakar Ramakrishnan, PhD, Lilly's Chief Digital Officer. "While further research is needed, the study findings provide important insight into the potential benefits of wearable devices in identifying chronic health conditions such as MCI, Alzheimer's disease, and Dementia. These findings could inform subsequent research that may eventually lead to early screening or detection tools for neurodegenerative conditions." In ways not previously detected through common clinical screening tools, data obtained through the use of Apple devices suggested an ability to differentiate between individuals with mild cognitive impairment and mild Alzheimer's disease dementia, and those without symptoms. The 12-week study evaluated 113 participants, ages 60-75, in real-world settings to determine whether Apple devices in combination with mobile applications, were able to help identify cognitive and behavioral differences among the study participants with and without mild cognitive impairment. Evidation established a secure study platform to obtain study participants' consent to collect and analyze 16 terabytes of data across a number of sources, including: passively derived sensor data from the smart devices, questionnaires about mood and energy, and simple assessment activities on the Digital Assessment App. The App included psychomotor tasks, such as dragging one shape onto another or tapping a circle as fast and as regularly as possible, reading tasks and a typing task. "With further study, we may be able to screen people at high risk or detect dementia and Alzheimer's earlier with the devices we use in our everyday lives," said Christine Lemke, Co-founder and President of Evidation Health. "These early findings suggest the potential Pharma Bio World

of novel digital measures that are based on data generated and controlled by individuals." "We are excited to work alongside Lilly and Evidation in supporting the research community, as they seek to discover digital biomarkers of cognitive impairment," said Myoung Cha, Apple's Head of Health Strategic Partnerships. The findings of the exploratory study provide feasibility evidence that wearable devices could enable solutions that may help identify and indicate when people are starting to experience cognitive decline. Specifically, these results show that Apple devices and digital applications may have the potential to: • Monitor symptoms of people diagnosed with MCI or mild Alzheimer's disease dementia • Detect cognitive changes that could be indicative of MCI • Test the efficacy of treatments and therapies • Accelerate the development of therapies used in conjunction with traditional diagnostic tools to improve accuracy of diagnoses.

GSK Collaborated with Pfizer to Form New World-leading Consumer Healthcare Joint Venture

Brentford, United Kingdom; NewYork, United States: The Joint Venture brings together two highly complementary portfolios of trusted consumer health brands including GSK's Sensodyne, Voltaren, and Panadol and Pfizer's Advil, Centrum, and Caltrate. Underpinned by science-based innovation, it is the global leader in OTC products and has number 1 or 2 market share positions in all key geographies, including the US and China. Following today's announcement, the Joint Venture will focus on completing the integration of two businesses, which is expected to realise annual cost savings of GBP 0.5bn by 2022 for expected total cash costs of GBP 0.9 billion and non-cash charges of GBP 0.3 billion. Up to 25 percent of the cost savings are intended to be reinvested in the business to support innovation and other growth opportunities. Brian McNamara, Chief Executive Officer, GSK Consumer Healthcare, said: "Now the deal is closed; our focus will be on completing the integration of these two businesses and leveraging their combined strength. With our portfolio of brilliant, science-based brands and strong talent and capabilities, we are well-positioned to create a world-leading consumer healthcare business with stronger sales, cash flow, and contribution to earnings." As previously announced, GSK intends to demerge the Joint Venture from the company within three years and to list the GSK Consumer Healthcare Business on the UK equity market. Emma Walmsley, Chief Executive Officer, GSK and Chair of the Joint Venture, said: "The completion of the joint venture with Pfizer marks the beginning of the next phase of our transformation. This is an important moment for the Group, laying the foundation for two great companies, one in Pharmaceuticals & Vaccines and one in Consumer Health." August 2019 ► 39

press release Siemens Healthineers to Buy Robotic-assisted Vascular Interventions Leader, Corindus Vascular Robotics for USD 1.1 billion Erlangen, Germany: Siemens Healthineers AG, a healthcare provider, has entered into a merger agreement with US based Corindus Vascular Robotics Inc, a global technology leader for robotic-assisted vascular interventions.

Under the terms of the agreement, Siemens Healthineers will acquire all fully diluted shares of Corindus for USD 4.28 per share in cash or USD 1.1 billion in total. The transaction is expected to be closed by end of calendar year 2019, subject to Corindus shareholder approval, receipt of regulatory approvals and other customary closing conditions. The Corindus board fully supports the acquisition proposal. Corindus is headquartered in Waltham, Boston, Massachusetts, and currently has approximately 100 employees. Corindus develops, produces and sells robotic systems for minimally invasive procedures. These systems help doctors to precisely control guide catheters, guide wires, balloon or stent implants via integrated imaging. The physician does not have to stand at the angiography table as usual but can control the procedure with a separate controlling module and is therefore less exposed to radiation. Corindus is currently one of the leading companies offering a robotic treatment platform for major vascular therapeutic markets, meaning coronary, peripheral vascular, and neurovascular interventions. For example, heart disease is the most common cause of death in the US Every year, more than four million percutaneous coronary interventions are carried out worldwide. The acquisition of Corindus meets the objective of simplifying today's challenges in everyday hospital life. Robotic assisted minimally invasive procedures have the potential to reduce treatment times, increase precision during treatment, raise standardization levels in clinical procedures, and ultimately improve clinical outcomes, which is the strategic focus of the Advanced Therapies business segment. “The interplay of exact imaging and robotic-assisted interventions will enhance both the eyes and hands of the physician, metaphorically speaking. With the addition of Corindus to our strong therapies portfolio we sharpen our procedural focus and will grow by expanding precision medicine and improving clinical outcomes. In the future, our digital and artificial intelligence-based tools will help to integrate the aspects of imageguidance and therapy even further”, said Michel Therin, President of Advanced Therapies at Siemens Healthineers. The CorPath systems developed by Corindus will be used together with angiography systems that Siemens Healthineers sells as one of the leading suppliers. The Siemens Healthineers products make minimally invasive treatment possible by using high-quality imaging before and during medical interventions. The company's leading role in image-based minimally invasive procedures is now complemented by robotic-assisted precision medicine. This expansion strengthens the therapy position of Siemens Healthineers and underlines its role as one of the leading solution providers along the entire treatment path. This makes the acquisition of Corindus a strategically significant extension of Siemens Healthineers' therapy business. 40 ◄ August 2019

The future integration of Siemens Healthineers digitization and artificial intelligence solutions with Corindus' robotic systems offers further promising possibilities. The aim is to further increase procedure optimization in order to enable the greatest possible degree of efficiency and clinical reproducibility. In addition, Corindus is driving forward the approval procedure for remote robotic treatment in vascular interventions. Due to the limited availability of specialists for minimally invasive procedures in many regions and the limited number of corresponding clinical facilities, remote treatment could significantly improve patients' access to treatment in the future.

Windgap Medical Partnered with ALKAbelló to Commercialize Epinephrine Auto-injector to Treat Anaphylactic Shock Watertown, USA: Windgap Medical Inc, a privately-held pharmaceutical company, announced that it has entered into a strategic partnership with ALK-Abelló, A/S (ALK) to commercialize the company's epinephrine autoinjector (EAI) for the treatment of anaphylactic shock.

Under its agreement with Windgap, ALK has exclusive worldwide sales and distribution rights for the Windgap EAI in exchange for up-front, technical, and sales milestone payments along with tiered royalties on net sales in the USA, along with a split of net profit for products sold outside of the USA. EAIs are used for the emergency treatment of acute allergic reactions – also known as anaphylaxis – which can be triggered by exposure to certain foods, or by exposure to venom from bee or wasp stings. There are more than 200,000 cases of anaphylaxis each year in the USA, and a study by the Asthma and Allergy Foundation of America estimated that up to 16 million Americans will experience it during their lifetime. Windgap estimates that the EAI market in the USA exceeds USD 1 billion annually, with a large unmet need that may enable significant market growth. Windgap and its manufacturing collaborators are commercializing its ANDIPen wet/dry autoinjector platform. The first product using this platform will be epinephrine for the treatment of anaphylaxis. The EAI is designed to address many unmet patient needs like portability, temperature stability, ease-of-use, and a long shelf-life. "Windgap is excited to be working with ALK, a world-leader in the treatment of allergy with a strong understanding of the world-wide EAI market, to help commercialize our product. Our teams are working well in partnership to support that effort," said Chris Stepanian, Windgap's CEO and Co-founder. "Windgap has worked hard to assemble a world-class team to commercialize our epinephrine auto-injector. I believe the global market to be sizable and significantly under addressed. In addition to our partnership with ALK, we have strong support through a strategic investment by Molex Ventures. Molex represents one of our major manufacturing collaborators who is investing along-side our Series B lead investor Shepherd Kaplan Krochuk." Windgap's products have not been reviewed by the FDA but the Company intends to seek approval first, for its epinephrine product for anaphylaxis. Pharma Bio World

press release Health Ministry asked Medical Device Manufacturers to Register at Information Sharing Portal as Part of MvPI

India: In order to effectively implement the Materiovigilance Programme of India (MvPI), the Union Health Ministry has directed medical device manufacturers to register at the recently launched Medical Devices Information Sharing Portal through hyperlink - www.mvpi.co.in. This portal would serve the purpose as an India specific tool to help Indian Pharmacopoeia Commission (IPC) facilitate baseline study of products available with medical devices companies in India and assure patient safety. IPC in consultation with Central Drugs Standard Control Organisation (CDSCO)has developed the portal to ensure that safe medical devices are available in the country. IPC has been keenly working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI which was launched in 2015. Other reporting tools and reference documents for manufacturers available on IPC website are an updated medical devices adverse event reporting (MDAER) Form (version 1.1), a field safety corrective action (FSCA) form, a reference manual for medical devices and a handbook for MvPI.

with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number, etc. As many as 4,700 patients in India had been affected by the faulty articular surface replacement (ASR) hip implants in India. The implant manufactured by J&J subsidiary DePuy Orthopaedics Inc was globally recalled over concerns that metallic implants could leak toxic cobalt and chromium into patient's body and pose risk to human health.

Cipla Q1 net profit rises 6% to Rs 478 crore Mumbai, Maharashtra: Pharma major Cipla saw its consolidated net profit rise by almost 6 percent during the June quarter to Rs 478.19 crore. The company had posted a profit of Rs. 451.25 crore during the year-ago period. Cipla reported net income from operations for the three-month period under review at ` 3,894.46 crore, as against ` 3,845.84 crore during the year-ago period. The total revenue for Q1FY20 was ` 3,989.02 crore, in comparison to ` 3,938.99 crore seen during Q1FY19. The company reported EBITDA (Earnings Before Interest, Tax, Depreciation and Amortisation) of Rs 905 crore for the June quarter, 25 percent higher than what was reported during the corresponding quarter last year. The EBITDA percentage was 22.7 percent.

Union Health Ministry is also planning to create a Registry of High Risk Medical Devices to effectively study and follow medical device associated adverse events (MDAE) and enable dangerous ones to be withdrawn from the market.

"The paid-up equity share capital stands increased to ` 161.17 crores (80.58 crores equity shares of Rs 2 each) upon allotment of 1.27 lakh equity shares of ` 2 each pursuant to "ESOS 2013-A" during the quarter ended June 30, 2019," Cipla said in a regulatory filing.

The registry would track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises at the manufacturerâ&#x20AC;&#x2122;s end.

"We witnessed a muted first quarter in FY20 owing to a combination of external volatility and some conscious business decisions taken with the long-term sustainability in mind. Our secondary growth in our flagship therapies in India and in the South Africa private market remained impressive, and our base business in the US saw y-o-y growth with increased revenue from recent high-value launches," said Cipla MD and Global CEO Umang Vohra.

MvPI which was launched in 2015 to ensure safety of medical devices is currently being coordinated by the IPC at Ghaziabad. IPC functions as the NCC for MvPI and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as its collaborating centre. Technical support is being provided by the National Health System Resource Centre (NHSRC) in New Delhi. Uptill now, MvPI has put 17 exclusive centres under it to collect and disseminate reporting of adverse events due to medical devices at the point of care besides the 270 adverse drug reaction monitoring centres (AMCs) across the country. MDAER form launched by IPC will help generate independent, evidencebased recommendations on the safety of medical devices and to communicate the findings to all key stakeholders. The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available Pharma Bio World

"Our business fundamentals remain strong, and our overall base business profitability was maintained at healthy levels despite the volatility. Our growth drivers remain on track with sustained expansion of our basket of biosimilars in emerging markets, entry into new markets such as China to set up our respiratory franchise, and further depth in our U.S. specialty pipeline with ZEMDRI," Vohra further added Morevoer, Cipla Ltd signed a definitive agreement to acquire the minority stake of Eight Roads in Cipla Health Limited (CHL). Eight Roads had acquired minority ownership in CHL through two rounds of investment in April 2016 and August 2018. The latest deal will grant Cipla Ltd 100 percent ownership interest of CHL. Cipla shares closed at ` 519 on BSE, registering a gain of 18.80 points or 3.76 percent, after making an intraday high of ` 525.05 (4.97 percent). August 2019 â&#x2013;ş 41

press release Syngene, through Biocon Foundation, Narayana Health & Agastya International Foundation launch CHAMPS Initiative Bangalore, India: Syngene International in association with Narayana Health, Agastya International Foundation, and Biocon Foundation has launched CHAMPS (Child Health Activists Mentoring & Promoting Heath in Society). This is a student mediated initiative focused on preventing and managing early onset of noncommunicable diseases (NCDs). The initiative, currently rolled out as a five-month pilot, is intended to be a three-year program to educate students in prevention and management of early onset of NCDs and promote healthier lifestyle. In India, 60 percent of all fatalities are caused by NCDs: type 2 diabetes, cancer, heart, and respiratory diseases. Studies conducted across India reported high prevalence of hypertension with little to no awareness and control. The Fourth National Family Health Survey evaluated and reported hypertension in 207 million people (men 112 million, women 95 million). CHAMPS will address this public health issue of hypertension through 8th and 9th standard students trained to screen for these symptoms within their community. The combined synergies of Narayana Health as knowledge partner, Syngene and Biocon Foundation as funding partners, and Agastya International as the implementation partner will ensure greater awareness in the involved communities. The training modules are tailored to comprehension levels of students who have been enrolled; and are designed to create awareness on hypertension and training them in the use of the Blood Pressure apparatus. Kiran Mazumdar Shaw, Managing Director, Syngene International Ltd, in light of the initiative, said, “As indicated in the ‘Hypertension in India’ report by National Centre of Biotechnology and Information (NCBI), the number of fatalities in India, due to hypertension, has risen and the states with greater urbanization, human and social development have greater incidence. Through the CHAMPS , we shall engage high school students as change agents, by training them to screen for symptoms, record blood pressure readings and share it with relevant authorities. This will enable monitoring of NCDs in communities for corrective actions to be implemented.” The aim of Champs program is two-fold. First we would like to detect high BP at early stage to prevent future complications by appropriate treatment. By training high school students to record BP we are introducing passionate young kids to the world of medical profession and change the way healthcare is delivered 42 ◄ August 2019

globally,” said Dr. Devi Shetty, Chairman and Executive Director, Narayana Health. According to Ramji Raghavan, Founder Chairman, Agastya Foundation, the fundamental idea of the CHAMPS initiative of developing children as change agents in raising awareness of one of the NCDs, namely hypertension, ties in well with Agastya’s philosophy of developing children as young instructor leaders, who are change agents imbibed with a scientific temper. “This health awareness programme will be imperative in creating the much-required health awareness among the younger generation, giving them a sound body to harbour a sound mind. This will in return strengthen our nation and help in building a healthier future”, said R Umashankar, Principal Secretary, Karnataka Education Department.

Eversana Expanding their Business in Asia Pacific region Chicago, USA: Eversana, a leading independent provider of global commercial services to the life science industry, announced the rapid expansion of its Asia Pacific business with the addition of two new offices in Singapore and Mumbai. The announcement came as the company appointed a regional leadership team to be based in Singapore to drive the company’s growth and ensure client service. Eversana offers a fully integrated and independent commercial service platform designed to solve patient support, distribution, field force, compliance, and marketing challenges in the life science sector. As the Asia Pacific market grows, there is an increased need for global solution capabilities for companies headquartered in the area or aiming to expand in the region, as well as US and European headquartered companies looking to bring solutions to the APAC markets. “China and Japan are now the second and third largest life science markets; and are widely regarded as vital contributors to the future of precision medicine,” said Jim Lang, CEO, Eversana. “We recognize that a thriving global life science sector requires a commercial service platform that not only adds value at every stage of the product lifecycle, but also understands the unique business, regulatory and cultural intricacies of our global marketplace.” Worldwide, Eversana has more than 2,000 employees working from 25 locations, including offices in North America, Europe, and Asia. Eversana plans to invest significant capital resources to build its regional footprint and support talent development. The company expects to open offices in Shanghai and Tokyo by the end of 2019. “For ourselves and our customers, it’s not just an economic opportunity, but rather a moral imperative to bring these life transforming therapies to patients located in this region,” added Lang. Pharma Bio World

press release Pumas-AI Introduced Healthcare Software for Researchers & Clinicians

Maryland, Bultimore: Pumas-AI, a new University of Maryland, Baltimore (UMB) startup company established by University of Maryland School of Pharmacy (SOP) faculty members Vijay Ivaturi, PhD, Assistant Professor, and Joga Gobburu, PhD, MBA, professor, has released its first, cuttingedge software platform for pharmaceutical researchers and clinicians. Known as Pharmaceutical Modelling and Simulation (Pumas), the software was developed at UMB through a partnership with experts at Julia Computing. Software development efforts have been led by Christopher Rackauckas, PhD, senior research analyst in the SOP Department of Pharmacy Practice and Science, with significant input from independent contributor Joakim Nyberg, PhD, of Uppsala, Sweden. Pumas is a copyrighted, comprehensive platform based on the Julia programming language that contains multiple modules designed to meet the needs of analysts in the pharmaceutical industry, while also working to advance therapeutic innovation in the clinic setting.

at the speed of FORTRAN. Because Pumas is created entirely in Julia, users can make direct use of the language’s database, statistics, and visualization functionality – all without losing performance. Pumas was released in July in conjunction with a Julia language conference hosted by UMB. "Pumas is the first pharmaceutical modeling suite that is designed from the ground up to be used with modern graphics processing unit (GPU) hardware and parallelized stiff differential equation solvers. It also allows for integration of machine learning with pharmacometrics, enabling a new kind of science known as scientific machine learning or scientific AI," says Rackauckas. "We are excited to not only accelerate current workflows, but also help users explore the new, realistic models that are enabled by this technology." In addition, Julia is the programming language of choice for prominent researchers who work on projects at the cutting edge of machine learning as well as in differential equations research, which means that, unlike many other tools, Pumas has the unique ability to directly incorporate modern techniques to achieve maximal efficiency and accuracy.

“The success rate for pharmaceutical innovations is approximately two percent,” said Gobburu, who, in addition to his role in the Department of Pharmacy Practice and Science, also serves as Executive Director of the Center for Translational Medicine (CTM) at the School of Pharmacy. “Pumas software is tailored to revolutionize big data analytics in health care, unlike those tools used in other fields. By combining the extensive health care knowledge of our faculty and staff with the scientific computing experts at Julia Computing, we have developed a tool that will not only benefit business leaders working in the pharmaceutical industry, but also those who are caring for patients on the frontline of health care delivery.”

“At the CTM, we strive to develop point-of-care solutions for providers and clinicians that can help individualize treatment for patients,” said Ivaturi, who also serves as a pharmacometrician in the CTM at the School. “The Pumas software platform will be instrumental in helping us optimize treatments for a number of conditions and therapeutics.”

“Moving technologies with commercial potential, such as Pumas, into the public sector is an important aspect of what universities do,” said Phil Robilotto, UMB Associate Vice President, Office of Technology Transfer, and Director of UM Ventures, Baltimore. “This innovative health care data software created by SOP’s scientific team is a big success for UMB and will be incredibly beneficial to the public as it’s further developed.”

Unichem Laboratories Received USFDA Nod for Hypertension Management Drug

The Pumas software platform, licensed from UMB, is the first product released by Pumas-AI, whose goal is to double pharmaceutical and patient care success rates by democratizing tools and education in the health care data analytics space. Pumas provides a wide range of analytic capabilities for pharmaceutical and biotechnology development, as well as therapeutic decision making – addressing a crucial need for pharmaceutical companies and investors, who often base their decisions on a combination of technical, regulatory, and commercial success probabilities, all of which the Pumas software can provide quantitatively. “Pumas is our company’s first product specifically designed for professionals in the pharmaceutical and health delivery sectors to bridge this gap,” said Gobburu. “It leverages the Julia programming language, and combines modern artificial intelligence (AI) with traditional mechanistic models, allowing the CTM to foster one of its goals of enhancing real-world data analytics.” Julia was selected for its speed and succinctness as a programming language, which produces an interface that looks similar to R, but operates Pharma Bio World

He adds, “It is going to revolutionize therapeutic decision making and allow health care organizations to benefit from payor incentives by demonstrating substantial improvements to successful patient care.”

Mumbai, Maharashtra: Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure. The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing. The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC. As mentioned by the spokesperson of Unichem Laboratories, Hygroton tablets are indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. It is also used as an adjunctive therapy in edema, associated with congestive heart failure, hepatic cirrhosis, corticosteroid, and estrogen therapy, and the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Unichem said the product will be commercialised from its Ghaziabad plant. August 2019 ► 43

press release Cadila Pharma Bagged TISS LeapVault CLO Awards in Two Categories Ahmedabad, Gujarat: Cadila Pharmaceuticals has bagged two TISS LeapVault CLO awards under the categories of Program for Sales Enablement and Social Media Based Learning Program. Tata Institute of Social Science-Leapvault CLO Summit and Award brings together leaders from human resource, corporate learning, coaching, organisation and leadership development. This award was conferred on the Learning and Development (L&D) team of Cadila Pharma for their initiative of training the field force using WhatsApp. Cadilas L&D team thought of an idea of using the existing platform of Whatsapp to increase their reach. Hence, the team merged e-learning with social media for the training of the field force. The L&D team of Cadila Pharmaceuticals began its training program in January 2019. The objective of the training is to build customer-centric capabilities of its diversified field force using new-age learning tools. The company adopted a mix of classroom teaching and e-learning using WhatsApp as a tool to ensure the application of the key learnings. The L&D team trained 1,999 employees across 13 locations in ten days. For the remainder of the training program, the team used WhatsApp to ensure a regular connect was maintained with the teams. Through innovative weekly campaigns of selfies, audio and video clips to ensure the application of the learning, which included grooming, interpersonal skills, and communication. Dr. Sunil Singh, the Chief Human Resource Officer of Cadila Pharmaceuticals, and Ajay Tyagi, Chief Learning Officer of Cadila Pharma were the brains behind this creative solution. “We observed 30 percent adoption among our colleagues, which is higher than the standard 2025 percent usually seen in e-learning. This initiative is one more step towards our vision of becoming a progressive, transformative, and a caring organization”, Dr Singh said in a statement. This recognition comes recently after two awards won by Cadila Pharmaceuticals for the Best Warehouse Workforce Award at the Second Annual Future Warehouse Summit Awards 2019 in the month of July 2019 and a WorldStar Packaging Award in May 2019. Cadila Pharma has been making bold moves to ensure a culture of excellence. With multiple initiatives like four-day summer break, leave on first Saturdays and flexi timings, Cadila Pharma has remained committed towards breaking the age-old practices of manufacturing industry.

Shimmer Won Two GHP International Life Sciences Awards for its Wearable Sensor Technology Staffordshire, United Kingdom: Shimmer Research, a global leader in wearable technology for research applications, announced that it has been honored with two GHP International Life Sciences Awards – Best Clinical Trials Wearable Sensor 44 ◄ August 2019

Technology Company USA, and Best Researcher Wearable Wireless Technology Provider 2019. Shimmer was recognized for its verisense wearable sensors platform, which was designed from the ground up for clinical research; its NeuroLynQ consumer neuroscience platform, which uses scientificallyvalidated galvanic skin responses (GSR) to monitor an audience’s emotional response to stimuli; and its Shimmer3 sensor platform, which records additional biometric measures, such as electrocardiography (ECG) and electromyography (EMG). “For more than 10 years, Shimmer has been a wearable sensor leader in the academic and corporate research markets, most recently with our Shimmer3 platform,” said Geoffrey Gill, President of Shimmer Americas. “We are very grateful for the thousands of researchers around the world who have developed innumerable algorithms to interpret wearable sensor data. During the past two years, we have leveraged that experience to develop highly tailored offerings for the clinical research and consumer neuroscience markets. We are delighted to receive these two GHP International Life Sciences Awards for our wearable sensor technology. It is welcome recognition that we have ‘hit the mark’ with our new developments.” Verisense was designed specifically to meet the specialized needs of clinical research, including improving data quality, while reducing burden on sponsors, sites, and participants. Sponsors gain access to secure raw participant data, which are validated using built-in algorithms. They also receive a dashboard that displays the status of the entire study at a glance, and allows drill down to individual sensors. Site setup takes five minutes and system alerts flag any issue that arises during the study in real time. Verisense sensors are also easy for participants to use; they can just put them on and forget about them. They can be worn all the time, even in the bath or shower, the battery lasts for up to six months, and data transfer is completely automatic. The Verisense platform can monitor up to seven sensors on a participant’s body, making it invaluable for studying complex musculoskeletal or neurological conditions, such as Parkinson’s disease or epilepsy. Designed for consumer neuroscience applications, NeuroLynQ allows an audience’s emotional response to be measured objectively in real time in a real-world setting using GSR. It has been used to measure audience reactions to events as diverse as the Super Bowl and a classical music concert. It can also evaluate audience response to new marketing or advertising material. It takes only a couple of minutes for audience members to learn how to put on the NeuroLynQ sensor and the platform can provide results from up to 45 people simultaneously in a format that is easy to use and interpret. Shimmer’s wearable sensors have gained widespread market acceptance because they are easy to use, reliable, and provide high quality, validated data. The company also ensures that its technology continues to evolve to meet changing market needs. Underscoring the popularity of Shimmer sensors, they are also used by more than 20 original equipment manufacturers in their products and services. Pharma Bio World

Oil-lubricated Vacuum Pumps Toshniwal supplies oil lubricated vacuum pumps. This oil-lubricated vacuum pumps of the TMS Series are single stage, oil-lubricated rotary vane vacuum pumps with oil re-circulation system. The lubricant system is rated for continuous operation of high intake pressures so that the pump may be used in a versatile manner in most rough vacuum applications. The pumps are used for suction of air also in presence of water vapour and for continuous industrial use. TMS Series pumps are made from high quality materials, has economical features which matches together to achieve: high pumping speed over the range of absolute pressure 1,000 mbar-0.5 mbar; high water vapour tolerance and low noise level; no pollution; and air-cooled: built-in anti-suckback system. The pumping capacities available are: 17-m 3 /hr, 35-m 3 / hr, 65-m 3 /hr, 100-m 3 /hr and 150-m 3 /hr. 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

Density Meter The DIMF Series density/concentration meter is based on the oscillating element principle. Major applications are process control and quality monitoring of fluids in all areas of industry. The device can also be used for density mass flow conversion for custody transfer in connection with the corresponding volumetric meters and flow computers. Features direct measurement of density, reference density or concentration; highest accuracy repeatability; measuring element suitable for CIP and SIP, self-draining (Type 2.0); no dead zones and no gaskets; independent of mounting position; long service life and high reliability due to the very robust construction; high long-term stability and is maintenance-free.

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Roots Pumping Systems Roots Pumping System is used where in high pumping capacity is required at lower operating pressure. The capacity available ranges from 250 m³/hr to 10,000 m³/hr. Toshniwal also provides appropriate accessories like condensers, filters, etc, to reduce the cycle time and protection of the pumping system. It brings in savings in power in the range of 30-40 per cent, improves the quality and productivity. It is easy to service and easy to install.

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

Digital Mass Flow Meters/Controllers Metal seal gas mass flow meters and controllers are characterised by their unique patented metal-to-metal seal construction with excellent resealing capability. Further more they distinguish themselves by a high surface quality and are therefore especially suitable for meeting the semiconductor and solar industry requirements as well as other high purity gas applications. Today’s instruments are equipped with a digital PC-board, offering high accuracy, excellent temperature stability and fast response (settling time t98 down to 500 msec). The latest EL-FLOW design features multi-gas/multi-range functionality, providing (OEM) customers with optimal flexibility and process efficiency. Features very low pressure drop and contamination risk; longer lifetime when used on corrosive gases; easy to clean; and electro-polished stainless steel wetted parts. They are available with control valve to constitute a complete, compact control loop and with industrial (IP65 weatherproof) housing.

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Filter Bags Filter bags available in needle felt and mesh type material. All materials are FDA compliant. There are wide selection of filter media, eg, polypropylene, polyester, nylon, cotton, non-woven and various micron ratings from 1 to 200 (felt material); positive sealing arrangement with SS or rubber or plastic collar or by snap band type ring. They are available in single and double length; and broad chemical compatibility. For more information, please contact:

National Card Board Mills Plot No: 140-2/B/2 GIDC Estate Ankleshwar, Dist: Bharuch Gujarat 393 002 Tel: 02646-252569, 222569, Fax: 02646-253002 E-mail: ncbmfilter@gmail.com

Vacuum Pumping Systems Booster/dry screw pump vacuum pumping systems combine high pumping speed with deep vacuum levels and operate free of oil, water or other sealing liquids. Available in 2 and 3 stage configurations; flexible options for customisation â&#x20AC;&#x201C; inlet filters for drying/ powder applications; automatic solvent flushing; automatic nitrogen purging and nitrogen flushing; post condensers with receivers; automation and instrumentations; electric control panels with variable frequency drives; standard and flame proof type varying electrical motors; skid mounted systems with interconnecting piping and valves. For more information, please contact: Everest B-44 Mayapuri Indl Area, Phase 1 New Delhi 110 064 Tel: 011-45457777 E-mail: enquiry@everestblowers.com

Dust Collection Cartridges Pleated dust collection cartridges are made of 100 per cent polyester media with different coatings on it, as per requirement of applications. Manufacturer of dust collectors originally designed to build the dust collection cartridges in equipment whereas pleated bags can be used for existing dust collector in place of conventional dust collection bags, without modifications. This polyester media is made of high tenacity filament yarn without using any binding agent. Thus, hard finished material is very stable against hot gas attached and structurally durable. This unique and hard finished material provides features of good pleat ability, high durability and unique structure of very fine filament yarn which offer high performance in filtration. Thermally tight bonded media provide washability, excellent pleatability, stable structure, fine dust release and good resistance of particle penetration into the media. These filter media are pleated in different pleated depths and height to accommodate desired filtration area. Construction pleated spun bonded filter media placed in a cylindrical configuration with support of metal core and encapsulated with metal-end caps to form pleated dust collection cartridges.Features high filtration area up to 20 m 2; universal fixing arrangements; open pleat spacing; low consumption of compressed air for cleaning; high air to cloth ratio and high filtration efficiency. For more information, please contact: National Card Board Mills Plot No: 140-2/B/2 GIDC Estate Ankleshwar, Dist: Bharuch Gujarat 393 002 Tel: 02646-252569, 222569 Fax: 02646-253002 E-mail: ncbmfilter@gmail.com

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Water Ring Pump & Booster Vacuum Pumping Systems Booster/water ring pump vacuum pumping systems are ideal for pumping wet gas mixtures at low pressure. Sealing liquid used being water gives this system good flexibility for use in various applications. They are available in 2 and 3 stage configurations and are widely used in various essential oil, cardanol distillations and CNSL applications. Flexible options for customisation – inlet filters for drying/powder applications; post condensers with receivers; automation and instrumentations; electric control panels with variable frequency drives; standard and flame-proof type varying electrical motors; skid-mounted system with interconnecting piping and valves.

For more information, please contact: Everest B-44 Mayapuri Indl Area, Phase 1 New Delhi 110 064 Tel: 011-45457777 E-mail: enquiry@everestblowers.com

Platinum-cured Silicone Hose Reinforced with Polyester Braiding Imafit is platinum-cured silicone hose reinforced with polyester braiding. It has excellent flexibility for pressurized fluid transfer application in pharma and biotech industries. Ami Polymer is catering these products to all pharma and biotech companies in India as well as overseas market. Imafit hose is manufactured under stringent quality parameters to have greater flexibility and minimum bend radius. Imafit conforms to US FDA 21 CFR 117.2600 Food Grade Standard, USP Class VI and ISO 10993-1. It is certified by ROHS and TSE/BSE Certification (free of animal derived material). It is free of restricted heavy metals and Phthalate/Bisphenol/Volatile Plasticizer. Complete validation package available upon request. Imafit is manufactured from low volatile grade silicone resin. It is excellent in flexibility and has lot traceability features. It imparts no taste and odour. It is available with SS-316L Tri-clover end fittings in required length. It is also available in colored outer layer and custom colour coding. It has flexibility at lower temperature up to -80°C and high heat resistance up to 180°C. It is sterilisable by autoclave, ethylene oxide gas and gamma radiation. Sandwich printing technology in which fine layer of platinum-cured silicone is applied over printed hose. It gives permanent print which avoids direct product contact. It can be laser etched hoses for permanent identification on outer surface of hoses. It is for ease of on-product traceability. It is available with nylon braid reinforcement on request. It is also available with bi-colour coding strips/lining for colour coding based product identification to avoid mix-up while usage on request. For more information, please contact: Ami Polymer Pvt Ltd 319 Mahesh Indl Estate Opp: Silver Park Mira-Bhayander Rd Mira Road (E) Thane, Maharashtra 401 104 Tel: 022-28555107, 28555631, 28555914 E-mail: mktg@amipolymer.com

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Automated Liquid Sampler A safe and reliable method for collecting multiple liquid samples from heated and pressurised reactors has been sought for many years. Parr Instrument Company offers the 4878 automated liquid sampler which can extract up to six liquid samples at a user-defined interval without the need for the continued presence of an operator. Features touch screen controller with easy to navigate graphical displays; standalone design compatible with any new or existing Parr reactors and pressure vessels; user-definable parameters including time between samples, number of samples and number of loop sequences; capability to connect with mobile devices on both iOS and Android platforms. For more information, please contact:

Orbit Technologies Pvt Ltd B-50 Indl Estate, Sanath Nagar, Hyderabad Telangana 500 018 Tel: 040-67216354, Fax: 91-040-23801579 E-mail: orbit@orbitindia.com

Innovative Drive Solutions All NORD drives are Industry 4.0 READY and can be directly integrated as active components in Industry 4.0 environments throughout the world. The prerequisites for this are the internal PLC as decentralised intelligence and the extensive range of communication options. The drive units are compatible with all common field buses and Ethernet-based protocols and provide analogue and digital interfaces for sensors and actuators. Thanks to the integrated PLC in the drive electronics they can provide autonomous control of sequences and movements and reduce the load on the central control system. As well as this, the drive systems are scalable, so that they can be individually adapted to the automation application with regard to complexity, quantity and size. NORD drives are prepared for integration into a cloud and can be connected to various external cloud systems. Fast, efficient and comprehensive evaluation of analogue and digital data by the intelligent PLC in the drive electronics forms the basis for modern maintenance and servicing concepts such as condition monitoring and predictive maintenance. Due to continuous monitoring of the field level, linking of communication, sensors, process data and vital parameters of the drive, deviations from the normal state can be quickly detected. Drive operators therefore have the possibility of responding in good time before damage or breakdowns occur. Condition-oriented maintenance replaces time-based maintenance. At present NORD is investigating sensorless monitoring of oil ageing and the condition of geared motors with virtual sensors. The aim is a predictive maintenance concept which determines the optimum oil change and maintenance intervals for each individual geared motor, oriented to the actual condition of the geared motor and the gear oil. For this, intelligent algorithms evaluate the operating data of the frequency inverter and determine the oil temperature from this information. Without the hardware costs for external sensors, oil ageing and the optimum time for replacing the gear unit lubricant can be determined with great reliability. Tests have shown that the oil temperature as measured in tests can be reliably calculated. For more information, please contact:

NORD DRIVESYSTEMS Pvt Ltd 282/2 & 283/2, Plot No: 15, Village Mann Tal: Mulshi, Adj Hinjewadi MIDC Phase II Pune, Maharashtra 411 057 Tel: 020-39801217, Fax: 91-020-39801416 E-mail: monika.mishra@nord.com / pl.muthusekkar@nord.com

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Silicone Inflatable Seals and Gaskets Imaseal is made from advanced grade silicone rubber conforms to FDA 21 CFR 177.2600 for food grade criteria suitable for various sealing applications. These inflatable seals starts inflation range from 5-mm to 20-mm when 2-4 kg/cm 2 pressure is applied after installation in door. Imaseal is certified by Food Grade Certificate (conforms to FDA 21 CFR), Laboratory Test Report, TSE/BSE Free Certificate and Phthalate Free Certificate. Imaseal is used in fluid bed dryers/processors/coaters, autoclaves, sterilizers, isolators, glove box, furnaces, rapid mixer granulators, nuclear door seals, robotics and fluid sealing, airlock door seals, powder and bulk solid handling machineries, electronic/wafer semiconductor processing, etc.

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

Intellicyt iQue3 The new iQue3 (Intellicyt iQue3) from Sartorius is designed to provide fully automated processing and analysis for flow cytometry workflows, taking you from samples to actionable answers faster than ever before. Successor to the iQue Screener PLUS, the new generation instrument offers even more user-friendly operation and enhanced process security to ensure consistent and reliable results with minimal user intervention. One of the iQue3’s new features is an enhanced rinse station that actively monitors buffer usage. With built-in liquid level detection, this module offers a smarter way to ensure you always have sufficient buffers to complete your run. This is complemented by a number of updates to the system’s intuitive ForeCyt software, which uses a unique templated analysis approach to offer intelligent, fully automated data processing. This powerful software solution has been specifically developed to alleviate common processing bottlenecks by eliminating the need for manual data analysis and providing real-time visualization of your data for virtually any cell- or bead-based assay.

For more information, please contact: Sartorius Essen BioScience, Inc 300 West Morgan Road Ann Arbor, MI 48108, U.S.A. Tel: 734-769-1600 Fax: 734-769-7395 E-mail: info.intellicyt@sartorius.com

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Promatic PAK 130 Semi-automatic Case Packer The Promatic PAK 130 case packer downstream of the Promatic PTT provides secure aggregation of the serialised cartons. These semi-automatic machines in the PAK product family are thus in conformity with the rigorous standards for the manufacture of tamper-evident pharma packaging. On the Promatic PAK 130 both the grouping, aggregation and stacking steps and the insertion of the cartons into the cases are fully automated. The only manual steps with the semi-automatic machines are case erection and placement into the hopper by the operator. The filled cases are generally removed by hand. The Promatic PAK 130 currently achieves a max output of up to five cases per minute. A system for closing the carton flap with adhesive tape can be installed as an option. The case packer has a compact, ergonomic design with a very small footprint and is easy to clean and quick to retool. 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

Top Hung Sliding Doors Segment panelled doors providing more durability and long life. Wide range of different appearance as double skin insulated panels and single skin also. High grade track at the top holds the door firmly. No obstruction at the bottom as the bottom guide track is flushed at the floor. The top hung sliding doors are absolutely smooth in operation and sturdy against high wind pressure. No accumulation of dust and dirt on the track. These doors are available as motorized operated with bottom mounted Italian make motorized system. Smart and advanced drives and controls are perfectly harmonized to guarantee easy assembly and programming. Manually-operated version is also available. The door is hung by two specially designed heavy duty trolley hangers at the top. No accumulation of dust on the track as the door runs in a concealed track. Hence the door is smooth and easy in operation. At each end, a track stopper is placed to absorb any impact and to hold the door in the open or closed position. Additional guides at the bottom prevent the door from oscillation. Different types of vision and ventilation windows available as in Polycarbonate/Acrylic/Louvers. Construction of automatic sliding door panel, available in vast choice material like galvanized steel, SS, aluminium, polycarbonate, pre-laminated board and glass. Doors can be constructed with vertical EPDM rubber seal to prevent dust and provide complete sealing. These sliding doors can be provided with in-built pass doors for pedestrian access. A total safety system, automatic sliding doors are designed to meet all operational and safety needs. For more information, please contact: Avians Innovations Technology Pvt Ltd Gat No: 60/61, Dehu-Moshi Road, Chikhali Pune, Maharashtra 412 114 Tel: 020-71400600 Fax: 91-020-71400654

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Thermoplastic Elastomer Tube (TPE) Imaprene is opaque tubing especially known for its excellent flexibility and flex crack resistance. Imaprene is manufactured by using advanced grade 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 has superior flex crack resistance and durable for any application. It has smooth bore to ensure least contamination. It is non-toxic and non-haemolytic. It is highly recommended for medical, food and pharma applications. It is sterlisable by using different techniques like autoclaving, ethylene oxide and gamma radiation.

Sliding Glass Doors One of the prominent sliding doors is glass sliding doors. They are mostly used for small span entrance openings of companies and administrative departments. They make the inner interiors of the hall easily visible to the outsiders making them keen and interested during their visits. Glass sliding doors are totally automatic and used for frequent opening and closing. The operation timing of these doors can be easily set or reset for that matter. Door open and close at a speed of 100-450 mm/sec (adjustable). These doors are also available as manually-operated door. Smart drives and controls are perfectly harmonized to guarantee easy assembly and programming. It has a heavy-duty top-mounted track with timing belt and no obstruction at the bottom. Doors can be constructed as partly pre-coated panelled/aluminium sheets and partly glazing sheet. Automatic glass sliding doors can be constructed with vertical EPDM rubber seal. These doors offer interlocking facility between two doors. The automatic sliding doors can be included with additional safety devices. Actuators such as radar detectors, pushbuttons, loop detectors or remote control can be added to the control system. For more information, please contact: Avians Innovations Technology Pvt Ltd Gat No: 60/61, Dehu-Moshi Road, Chikhali Pune, Maharashtra 412 114 Tel: 020-71400600 Fax: 91-020-71400654

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Dust Extractors Dustcontrol UK offers a range of its highly effective equipment of both fixed and mobile cyclone-based dust extractors and air cleaners. The DC 11-Module for example, which comes in several models, is an optimised stand-alone unit for source extraction and industrial cleaning. It has been designed to service up to six normal extraction points or several cleaning outlets at a time, and is modularly built, meaning it can be tailor-made to suit any manufacturing and production environment. As with all of Dustcontrol UK’s equipment, the DC 11-Module can be fitted with Hepa 13 filters, meaning exhaust air can be safely returned to the work environment. The company, based in Milton Keynes, has many years of experience in developing dust extraction solutions and centralised vacuum systems to fit client requirements in the manufacturing and production industries. They are experts in capturing dust at its source - both where and when it is created. For more information, please contact: Dustcontrol UK Ltd 7 Beaufort Court, Roebuck Way Knowlhill Milton Keynes MK5 8 HL, U.K. Tel: 01327 858001, Fax: 01327 858002 E-mail: sales@dustcontrol.co.uk.

Custom-made High-pressure Solutions In addition to high-pressure compressors, Sauer Compressors also offers a wide range of accessories specially designed for medium- and high-pressure solutions. These include compressor controls, air and gas dryers as well as storage and distribution solutions. The new Sauer ecc 4.0 compressor control system is a cornerstone in Sauer’s accessories portfolio. The control is based on an intelligent modular design principle that enables an exact adaptation to the individual version of the compressor. It is also highly customisable, because its software was developed entirely in-house by Sauer. The new control supports communication via all common interfaces and can therefore be easily integrated into higher-level systems. In operation, the innovation convinces with its simple and intuitive usability via a 7” touch display. Sauer also offers solutions for drying and storage that are individually tailored to the requirements of the individual application. There are two dryer series specially designed for high-pressure applications. The high-pressure refrigerant dryers of the Sauer SRD Series are suitable for drying air and gases with final pressures of up to 420-barg and achieve a pressure dew point of 3-5°C. They can also be used as gas coolers. The high-pressure adsorption dryers of the Sauer SDD Series achieve reliable dew points of up to -40°C at final pressures of up to 350-barg. They are specifically designed and optimised for use with Sauer high-pressure compressors. Also available is a wide range of high-pressure storage systems for wet and dry gases with capacities of up to 600 l and for pressures of up to 350-barg. Versatile condensate management solutions are available for proper condensate collection. Customers benefit from tailor-made solutions from a single source, carefully matched components and short delivery times. For more information, please contact:

J P Sauer & Sohn Maschinenbau GmbH Brauner Berg 15 24159 Kiel, Germany Tel: +49 431 3940-0 E-mail: William.Koester@sauercompressors.de

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Grammage Checking Kit Presto Stantest Pvt Ltd offers grammage checking kit. GSM round cutter is a consistent tool useful for precise circular cutting of samples. Used to check the grammage of various sample it cuts a sample with 100 sq cm sizes rapidly and accurately. For more information, please contact: Presto Stantest Pvt Ltd I-42, DLF Indl Area, Phase I Delhi Mathura Road Faridabad, Haryana 121 003 Tel: 0129-4272727 E-mail: info@prestogroup.com

Decentralised Drive Technology Decentralised frequency inverters offer many advantages. With its extensive range of modular products for decentralised drive electronics NORD DRIVESYSTEMS covers practically all requirements and applications. The drive components have a power range up to 22 kW and an integrated PLC as standard to enable a high level of plug-in capability. They can be freely configured, to adapt them to any application. NORD decentralised drive technology can be integrated into all automation architectures and significantly reduces plant design costs. The invertersâ&#x20AC;&#x2122; integrated PLC is able to reduce the load on the higher level control system and take on independent control tasks. This allows a plant design with autonomous production groups and production islands. The freely programmable PLC processes the data from sensors and actuators and can initiate control sequences, as well as communicating drive and application data to a control centre, networked components or to cloud storage. This enables continuous condition monitoring and therefore forms the basis for predictive maintenance concepts as well as optimum plant dimensioning. This drive control for flexible decentralised installation is available as frequency inverter (up to 7.5 kW) or motor starter (up to 3 kW) and provides what it takes to enable fast commissioning, simple operation and maintenance. With NORDAC LINK all connections are made with simple plug connectors. In addition to the high plug-in capability, integrated maintenance switches and switches for manual operation ensure a high level of user-friendliness. With its power range of up to 22 kW, the NORDAC FLEX is the most flexible NORD inverter. With simple parameter transfer via EEPROM memory, installation and servicing are quick and reliable. NORD inverters can be easily extended and offer an impressive variety of scenarios for use in Industry 4.0 automation networks. Their fields of use range from conveyor technology and intralogistics, to drive tasks in the packaging and food industries as well as pump applications and general mechanical engineering. For more information, please contact:

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Fluidized Bed Reactors Parr fluidized bed reactors are used extensively in the chemical process industries. The distinguishing feature of a fluidized bed reactor is that the bed of solid particles or catalyst is supported by an up flow of gas. This reactor provides easy loading and removing of catalyst. This is advantageous when the solids bed must be removed and replaced frequently. A high conversion with a large throughput is possible with this style of reactor. Such reactors inherently possess excellent heat transfer and mixing characteristics. For more information, please contact: Orbit Technologies Pvt Ltd B-50 Indl Estate Sanath Nagar, Hyderabad Telangana 500 018 Tel: 040-67216354 Fax: 91-040-23801579 E-mail: orbit@orbitindia.com

PROFIsafe-Module At present, NORD DRIVESYSTEMS supplies frequency inverters with integrated STO and SS1. The drive specialist provides fail-safe communication and safe movement functions according to IEC 61800-5 with the SK TU4-PNS PROFIsafe module. Functions such as SLS (Safety Limited Speed), SSR (Safe Speed Range), SDI (Safe Direction), SOS (Safe Operation Stop) and SSM (Safe Speed Monitor) can be integrated and expand the drive units’ safe stop functions. With this, the PROFIsafe interface module provides comprehensive safety for the reliable operation of plant and machinery. PROFIsafe is the world’s leading and generally used technology for safety applications for production and process automation. With SIL3 and PLe (Performance Level e) Category 4, the fail-safe communication protocol fulfils the most stringent safety requirements. The PROFIsafe fail-safe protocol extension for PROFINET enables standard and fail-safe information to be transmitted with integrated functional safety between the higher level machine or the plant control system and the NORD drives in a single network cable. The PROFIsafe bus interface SK TU4-PNS monitors safe compliance with the limit values and provides safe inputs and outputs. If a limit value is exceeded or undershot, the bus interface switches to a safe state. The voltage is disconnected from all outputs; input information is reset and transmitted to the higher level fail-safe controller. This is essential for the use of the PROFIsafe module. Integration of safety functions into the drive unit offers many advantages in comparison with a drive solution with discrete safety technology. Another advantage is the global availability of the security-related machine data. For more information, please contact:

NORD DRIVESYSTEMS Pvt Ltd 282/2 & 283/2, Plot No: 15, Village Mann Tal: Mulshi, Adj Hinjewadi MIDC Phase II Pune, Maharashtra 411 057 Tel: 020-39801217 Fax: 91-020-39801416 E-mail: monika.mishra@nord.com / pl.muthusekkar@nord.com

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events diary Analytica Anacon India and India Lab Expo

Pharma Pro&Pack Expo

Dates: 19 – 21 Sep, 2019 Venue: Hitex Exhibition Centre, Hyderabad, India

Analytica Anacon India and India Lab Expo is an international trade fair focusing on laboratory technology, analysis, biotechnology, and diagnostics. The fair exhibits chromatography, spectroscopes, microscopes and imaging, bioinformatics, medicine and diagnostics, life sciences, analytical instrumentation systems, instruments for physical and chemical analysis, laboratory furniture, equipment, machines, and laboratory diagnostics related products. Highlights of the event: • Extensive support program. • Practical demonstrations and Lectures. • Direct interaction between buyer and seller. • Clear focus and perfect overview • Presence of Industry Leaders

Pharma Pro&Pack is India’s leading exhibition in pharma manufacturing technologies, with a niche focus on packaging and processing machineries. The exhibition envisions empowering the sectors of pharma machinery & processing manufacturers through its exclusive networking platform, distinguished resources, and diverse segments bringing the best of what the industry has to offer under one giant canopy. The 2018 edition of Pharma Pro&Pack surpassed all expectations with a combined footfall of 9,641 trade visitors with analytica Anacon India and India Lab Expo and the exhibition featured over 50+ exhibitors and 65+ hosted buyers. Almost all top pharma companies within and around Hyderabad attended the exhibition in large numbers and delegation trips were arranged by Messe Muenchen India

Contact: Messe Muenchen India Pvt Ltd Unit No 762/862, Solitaire Corporate Park Building No 7, 167, Guru Hargovindji Marg, Andheri (E) - 400 093 Mumbai Tel.: +91 22 4255-4700 Fax: +91 22 4255-4719 E-mail: info@mm-india.in

Electronica India Dates: 25-27 September 2019 Venue: India Exposition Mart, Greater Noida, India

and IPMMA for several companies. Highlights of the Event: • Witness of over 2500+ live products demonstration & comparison feasibility amongst the available features at one single location • Meeting oppor tunity of over 400 best sellers from pharma processing & packaging machineries from across the globe • Availability of the decision-makers of leading companies within reach • Sourcing opportunity of high-quality products at competitive prices • Business relationship enhancement opportunity with vendors.

Electronica India is the leading platform in India focusing on electronic components, systems, and applications. It features semiconductors, embedded systems, display, micro and nano-systems, and sensor technology, automotive, wireless, and much more. Contact: Messe Muenchen India Pvt. Ltd. INIZIO 507 & 508, Cardinal Gracias Rd Chakala, Andheri (E) Mumbai - 400 099 Tel: 022-42554700, Fax: 91-022-42554719 E-mail: info@mm-india.in

• Scope of being acquainted with the latest technological trends and key industry issues Contact: Messe Muenchen India Pvt Ltd Unit No 762/862, Solitaire Corporate Park Building No 7, 167, Guru Hargovindji Marg, Andheri (E)-400 093 Mumbai Tel.: +91 22 4255-4700 Fax: +91 22 4255-4719 E-mail: info@mm-india.in

BioPharma World Expo 2019 ( South ) Date: 4-6 December, 2019 Venue: HITEX Exhibition Centre, Hyderbad, India

BioPharma World Expo 2019 is the best platform for both Indian and international manufacturers/service providers/startups connected with pharma machinery, CRAMS, CROs/CMOs, packaging, logistics, exports, APIs, generics, biotech, regulatory affairs, etc . It offers a unique opportunity to meet, network, and establish business partnerships. The concurrent conference tracks would highlight latest technological developments, market trends, investment opportunities, and challenges facing the industry. The technical sessions would cover pharmaceutical technology, biosimilars, green chemistry, compliance, etc. 56 ◄ August 2019

Contact:

Jasubhai Media Taj Building, 210, Dr D N Road, Fort, Mumbai - 400 001 Tel: 91-22-40373636 Email: amrita_patil@jasubhai.com Pharma Bio World

bookshelf Pharmaceutical Packaging Technology Publisher: Taylor & Francis Edited by: D A Dean, A R Evans, and I H Hall Price: ` 2885.00 No. of Pages: 646 Pages About the Book: Pharmaceutical packaging is a specialty segment in the overall packaging domain. This book provides an in-depth insight into pharma packaging technology, and acquaints the readers with various material and technology related matter. Along with this, a detailed account of rules and regulations pertinent to the subject are also mentioned. To meet the global market related knowledge need, this volume is arrayed with an wide range of issues, including various assessments. It covers the entire supply chain starting from raw materials to finished packaging products including assembly. The book also covers various drug delivery system, testing & evaluation, traceability, and additional safeguards.

Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities: Delivering Patient Safety, Increased Return and Enhancing Reputation Publisher: Ecademy Press Limited Author: Stephen McIndoe and Andrew Love Price: ` 1679.00 No. of Pages: 212 Pages About the Book: The book is themed on essential resource for implementing sustainable packaging, labeling, and artwork capabilities. Steve Richmond, Head of Global Packaging, AstraZeneca has written the foreword. The book enables the readers to understand and deliver the right mix of packaging artwork capabilities for organizational usage. This volume covers the following topics: the importance of artwork capabilities in delivering todayâ&#x20AC;&#x2122;s business strategy | the causes of artwork errors | elements to make up the overall artwork capability, which includes: business processes, education, training and competence assessment, design, technology, outsourcing, sustainable improvements, future developments, etc.

Pharmaceutical Packaging Innovations Author: Sandeep Kumar Goyal Publisher: Sanex Packaging Connections Pvt Ltd Number of Pages: 132 pages Price: ` 3723.00 About the book: The thought-process for this book creation was to bring the various innovation ideas and concepts with regard to pharmaceutical packaging together from a varied array of professionals, and to offer it to the readers very cost effectively. The nature, degree, and the amount of packaging at any stage reflects the need, material availability, and technology. The pace of technological change in packaging field gives birth to new innovative packaging ideas. The discussed view-points of dignitaries on ever-increasing need of meeting new challenges and integrating new knowledge lead to the way of innovation and get reflected in packaging, delivering, and consuming the goods. Pharma Bio World

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ad index Sr. No

Client's Name

Page No

Ami Polymer Pvt Ltd

Bry-Air(Asia) Pvt Ltd

Domino Printech India LLP

Flowmatic Engineering Co

HRS Process Systems Ltd

MIFA Systems/Business Bridges

Nichrome India Ltd

Suresh Enterprise

Inside Cover I

Toshniwal Instruments (Madras) Pvt Ltd

Toshvin Analytical Pvt Ltd

Vega India Level & Pressure Measurement Pvt Ltd

58 â&#x2014;&#x201E; August 2019

7,8,9,10

Pharma Bio World

Process Industry’s Gateway to Indian Market

ChemTECH

Bio Pharma

S P E C I A LT Y

WORLD EXPO 2021

World Expo 2021

WORLD EXPO 2021

30 International Exhibition and Conferences 24-27 February 2021

Concurrent Events:

2021

Venue: Bombay Exhibition Center, Goregaon (East), Mumbai, India

Engineering Procurement Construction

Scope for CHEMTECH + Biopharma World Expo 2021

Reﬁning &

CHEMICALS 2021

Industry

AUTOMATION

& Control 2021

Pumps, Valves & Fittings

WORLD EXPO 2021

WaterEX

WORLD EXPO 2021

Scope for Specialty Chemicals World Expo 2021

FACTS & FIGURES - CHEMTECH WORLD EXPO 2019

612

18962

Business Interactions: Meet over 800 exhibitors from across the entire value chain of the chemical process industry

Strategic alliances: Interact with the entire supply network across the Chemical, Pharma & Biotechnology sectors from a single location

Market analysis: Evaluate the Indian consumption market and get feedback with over 25,000 visitors walk-ins over 4 days

Organised by:

Jasubhai Media Pvt Ltd

923

2150

Supported by

Taj Building, 3 Floor, 210, Dr. D N Road, Fort, Mumbai – 400 001, INDIA. Tel: +91-22-4037 3636 Fax: +91-22-4037 3635, Email: sales@jasubhai.com, Web: www.chemtech-online.com Delhi Office: 803, Chiranjiv Tower, 43, Nehru Place, New Delhi - 110 019, India. Tel: 91-11-4674 5555, Fax: 91-11-2642 7404 • Ahmedabad - 07238038888 • Bangalore - 09444728035 • Chennai - 09176963737 • Delhi - 09818148551 • Pune - 09822209183 • Vadodara - 09898061072

th R.N.I. Date of Publication: ofmonth. every Postal month. Postal Registration No: MCS/207/2017-19 R.N.I.No.: No.:MAHENG/2002/08502. MAHENG/2002/08502. Date of Publication: 26th of26 every Registration No: MCS/207/2017-19 st R.N.I. No. 39849/82. Date of Publication: 1 of every alternate month thon 27th of every month. Total Pages:- 68 Posted at Patrika Channel Sorting Office, Mumbai 400001, Posted at Patrika Channel Sorting Office, Mumbai 400001, on 27 of every month. Total Pages:- 60

Process Industry's Gateway to Indian Market

ChemTECH SOUTH WORLD EXPO 2019

International Exhibition and Conferences

4-6 December 2019 Venue: HITEX Exhibition Center, Trade Fair Ofﬁce Building, Izzat Nagar, Kondapur PO, Hyderabad, India Concurrent Events

L AB

SOUTH WORLD EXPO 2019

Exhibitors Proﬁle •

Chemical Processing

•

Pharma & Biopharma processing

•

Laboratory Technology

•

Measuring & Testing

•

Quality Control

• •

ANALYTIX

South World Expo 2019

WaterEX

SOUTH WORLD EXPO 2019

Industry

Visitors Proﬁle

End User Industry Connect

Chairmen, MDs , CXOs, Directors, Presidents & Vice Presidents

•

Heads of : Technology, Operations, Manufacturing, Procurement, Purchase & R&D

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Decision makers & representatives from State Governments, Industrial Development Corporations & Regulatory bodies

Analytical Instruments

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Scientists, Lab Managers & Technicians

Lab Equipment

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Quality Control /Assurance Managers

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R&D Ofﬁcers and Executives

•

Professors & Lecturers, Chemists & Bio Chemists, Microbiologists & Pathologists

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Lab Directors, Purchase Managers, Analysts, Research Scholars, Scientiﬁc Ofﬁcers

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Representatives from Municipal Corporation, Water Bodies and Regulators

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Environmental and Pollution Control Boards

•

Ministry of Rural Development and Drinking Water Mission

Pumps Valves & Fittings

•

Automation

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Water & Wastewater treatment

•

EPCs

•

Engineering Consultants

•

Environmental services

•

Emission Control

•

Safety

Facts & Figures South 2017

& Control South 2019

SOUTH WORLD EXPO 2019

•

AUTOMATION

Pumps, Valves & Fittings

182

EXHIBITORS

5971 VISITORS

• • • • • • • • • • • • • • • • • • •

Pharma & Biopharma Bulk Drugs APIs Biotechnology Chemical Processing Chemicals & Petrochemicals Agrochemicals Fine & Specialty Chemicals Oil, Fats & Oleo Chemicals Food & Beverages Advanced Materials Material Testing & Inspection Contract Research & Manufacturing Research Laboratories Clinical Research Labs Government Agencies Municipalities & ETPs Pollution Control Boards Water & Waste Management

SPEAKERS

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128

DELEGATES

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Jasubhai Media Pvt Ltd Taj Building, 3rd Floor, 210, Dr. D N Road, Fort, Mumbai – 400 001, INDIA. Tel: +91-22-4037 3636, Fax: +91-22-4037 3635, Email: sales@jasubhai.com Web: www.chemtech-online.com • Ahmedabad - 07238038888 • Bangalore - 09444728035 • Chennai - 09176963737 • Delhi - 09818148551 • Pune - 09822209183 • Vadodara - 09898061072