Express Pharma 16-30 November 2013, Part ||

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P MEC PRODUCT WATCH

Expertise in liquid filling and blistering systems by Romaco P Mec S P E C I A L ROMACO, A LEADING global supplier of processing and packaging equipment, will display the Macofar LF 200 ST, which is used for high-speed filling of sterile pharmaceutical liquids and the innovative Noack 960 Blister System, at P-MEC in Mumbai.

Macofar LF 200 ST sterile liquid filler High-speed machines that combine maximum product safety with extreme flexibility are in demand when it comes to filling sterile pharmaceutical liquids into vials. The Macofar LF 200 ST aseptic liquid filler meets these challenges. It is capable of processing injection vials and infusion bottles with an unusually wide range of filling volumes from 0.5 to 500 millilitres. The maximum filling speed of 12,000 vials an hour is achieved with volumes up to five millilitres. The machine complies with the rigorous cGMP requirements for processing sterile, parenteral pharma liquids. The balcony structure of the Macofar LF 200 ST facilitates a strict separation between the 'white' (cleanroom) and 'grey' (technical) areas. The critical area passed through by the open vials is very narrow and compact. The slim design of this area guarantees excellent sterility assurance levels (SAL). A vertical laminar flow prevents turbulent air movements in the vicinity of the open vials and stops particles and microorganisms from developing. The bottom-up filling process is intermittent and involves eight servo driven rotary piston pumps. Once filled, the glass or plastic vials are sealed with a rubber stopper and aluminium

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Macofar LF 200 ST sterile liquid filler

Noack 960 Blister System

cap. The Macofar closing system is also suitable for subsequent freeze drying. The time required to clean and retool this compact machine is comparatively short. The liquid filler consequently unites maximum product safety and quality with outstanding value for money. If desired, the Macofar LF 200 ST can be hooked up to an upstream sterile washing machine, a depyrogenation tunnel and a downstream Promatic cartoner to obtain a complete liquid filling line. The compatibility and system expertise of Romaco’s Macofar and Promatic brands thus generate several key benefits for users.

Noack 960 Blister System Very good OEE values are a must for smaller batch sizes and frequent product changeovers. Romaco’s Noack 960 Blister System provides an optimal solution for pharma manufacturers and contract packagers operating on a global scale. Short cleaning times, quick format changes and a high level of automation add up to extraordinarily efficient processes when packaging pharma solids. The blister system, which is offered with rotary or platen sealing, packs tablets, soft or hard gelatine capsules and caplets in a variety of shapes and sizes. The interchangeable QuickFeed unit is one of the Noack 960 Blister System’s technical highlights.

For the first time, parallel operating steps can now be realised instead of sequential if a second QuickFeed unit is installed. Product changes are completed in less than thirty minutes. Thanks to its smooth, readily accessible surfaces with no edges or corners to get in the way, the Noack technology is extremely fast and easy to clean. Less downtime and hence higher availability are the result. When teamed up with the Promatic PC 4000 continuous motion cartoner, the Noack 960 Blister System has a packaging capacity of up to 700 blisters and 400 cartons a minute. With their mature servo technology, the Noack and Promatic system components are optimally har-

monised and absolutely dependable. The modular layout of the Noack 960 Blister System with its balcony structure assures the highest possible flexibility and efficiency. Finally, the cGMP compliant and OEE certified Romaco technology convinces with excellent value for money. Contact details Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe Germany Tel.+49 (0) 721 4804 0 Fax+49 (0) 721 4804 225 email: susanne.silva @romaco.com


P MEC NEWS

Cisco,Panduit and Rockwell Automation, sponsor new online community Online community for engineering and IT professionals to discuss deploying a holistic Internet Protocol infrastructure P Mec S P E C I A L CISCO, PANDUIT and Rockwell Automation, in cooperation with ODVA, are sponsoring a new online community that extends the Industrial IP Advantage website. The community helps IT, engineering, maintenance and operations professionals transform industries by taking advantage of the future-proof interoperability delivered by Internet Protocol (IP). The Industrial IP Advantage discusses emerging-technology trends in industrial plants and IT networking – like the Internet of Things, convergence, big data and EtherNet/IP. The website offers guides, case studies, technical white papers, and online discussions on how these technologies can be applied to automation, industrial com-

pute, remote assets and services, video, energy management, mobility, and security and compliance. Many manufacturers use multiple networks with proprietary protocols to manage devices, which create breakdowns in communication within an organisation, increase threats to network security, and complicate IT management. This approach does not scale and creates inefficiency across manufacturing and business operations. To stay competitive, companies are looking to integrate the entire manufacturing value chain and leverage IP to seamlessly connect devices, processes, systems and people. “A common IP network seamlessly manages communication between digital devices, such as video cameras, RFID readers, controllers, instruments and digital tablets,

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with processes, systems and people from the plant floor to the corner office. IP extends innovative networking and management services for optimum levels of security, performance and ease of integration,” said Chet Namboodri, Director of global manufacturing solutions, Cisco. “IP integration is a critical factor for the evolution of industrial networks to assist in maximising plant uptime and ensuring long-time reliability,” said Steve Timian, Director of Industrial Automation Solutions, Panduit Corp. “This new online resource provides valuable education and knowledge-based experiences to assist in the imple-

mentation of sophisticated network architectures that provide connectivity from plant to enterprise,” Timian said. “The overwhelming majority of digital things will naturally depend on IP because of its overarching interoperability,” said Kevin Zaba, Vice President, Rockwell Automation. “Instead of overriding the power of IP, solutions such as EtherNet/IP put the software protocol to work, allowing industrial producers to easily extend collaboration to the plant along with other higherlevel services that IP supports.” EP News Bureau-Mumbai

Multisorb to showcase Sorbent Technology at CPhI and P-MEC India P Mec S P E C I A L MULTISORB TECHNOLOGIES will exhibit at the CPhI & P-MEC India exhibition from December 3-5 at the Bombay Convention and Exhibition Centre in Mumbai, India. During the event, Multisorb will be reiterating to the Indian pharmaceutical market the advantages of its Calculations through Operations program. Multisorb officially introduced this programme to this market during PharmaPack India in September of this year. This proven programme has helped countless manufacturers stabilise their pharma formulations with an optimised sorbent, saving them a considerable amount of time in the process. Through consultation, Multisorb’s scientists will gather information concerning the pharma product’s charac-

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teristics, its shelf life expectations, its packaging materials and configuration, and the environmental conditions it will be exposed to during transport and storage. With this information, Multisorb’s scientists will perform simulations of the environment inside the pharma packaging using its powerful and advanced technology, SimulSorb and SimulOx pseudo-empirical modeling software, which can predict the stability outcome for the drug product. The modelling can successfully determine the drug product’s sorbent requirement, including a traditional desiccant or oxygen absorber, an intelligent sorbent (IntelliSorb formulation), or no sorbent. This predictive model can eliminate sorbent ranging studies, saving 6-12 months of development time. Occurring in tandem with the determination of the correct sorbent formulation, the

sorbent platform (packet, canister, etc.) is also determined. Multisorb’s traditional sorbents and IntelliSorb formulations are available in Drop-In, Fit-In and Built-In formats. Drop-In sorbent formats include packets or canisters and are placed directly into the product packaging. Unlike Drop-In solutions, Fit-in solutions do not intermingle directly with the pharma product but instead are affixed within the packaging or pharmaceutical device. These include self-adhesive sorbents or coated, compressed sorbents that fit securely into a cap or available space within a device. Built-In sorbents are thermoformed device components with sorbent incorporated into the pharmaceutical device or packaging material, providing invisible but highly effective sorbent protection. Once the formulation and platform are determined, the final stage of the Calculations

through Operations programme, when Drop-In sorbents are preferred, is delivery of the sorbent into the product packaging. Multisorb packets and canisters are components of complete systems. Each is paired with its corresponding dispenser that has been specifically engineered to form a tightly integrated system with the sorbent, driving improved efficiency and reliability on the packaging line. One of Multisorb’s most popular and widely used systems, the StripPax System, will be available for viewing at its stand. Compact StripPax Sorbents Packets with high moisture and volatile adsorbing capacity are combined with its corresponding StripPax Dispenser – available with many options to customise it to your packaging line needs. One of the many StripPax Dispenser interface options available, and the one which

Multisorb will be demonstrating in the stand, is the APA2000 StripPax Dispenser with a bottling line interface. The APA-2000 is high-speed, automated StripPax Packet dispenser is capable of dispensing rates up to 300 packets per minute, giving it the ability to keep up with the fastest packaging line speeds. Constructed with the highest quality sensors, drive mechanisms, and cutters, the APA-2000 offers exceptional durability and provides the highest level of performance. Other interface options can be chosen to make the dispensers compatible with an array of packaging line configurations, including horizontal flow wrappers, VFFS, thermoformed pouching, and other layouts. (To learn more about Calculations through Operations or the StripPax System, visit Multisorb at stand no. P23.) EP News Bureau-Mumbai


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Vial Filling line

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Quality Through Experience By Erweka India

GmbH Germany

TBH 125 TD

TBH 425 WTD

TBH 525 WTD

Dissolution T Tester ester T Type ype USP 3 - 7

Dissolution T Tester ester

New Bathless Disintegration Tester Tester

Multicheck 5.1

Fully Automatic Disintegration Tester ester

GTB Granulate Flow Tester ester

Leak Test Test Apparatus

Local Contact Erweka India Pvt Ltd. Plot No. 29, Survey No. 415, N. H. No. 8A, Sarkhej-Bavla Road Village-Moraiya, Tal. Sanand, Dist. Ahmedabad-382213 Tele: +91-9228022065 Email : sales@erwekaindia.com www.erwekaindia.com

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Manufactured By

GmbH Germany

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Switzerland Dedusting & Deburring innovated by Kramer worldwide Deduster

Deduster with Metal Detector

More than 150 Installations in India For Sales & Service Erweka India Pvt Ltd. Plot No. 29, Survey No. 415, N. H. No. 8A, Sarkhej-Bavla Road Village-Moraiya, Tal. Sanand, Dist. Ahmedabad-382213 Manufactured By Tele: +91-9228022065 Email : sales@kraemerindia.com http://www.kraemerag.ch/ Switzerland EXPRESS PHARMA

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We care for your family . . .

Anti-Inflammatory Enzymes Serratiopeptidase Peptizyme (enteric coated serratiopeptidase granules) Trypsin Chymotrypsin mix ( 6:1)

Probiotics Saccharomyces boulardii Lactic acid basillus sporogenous

Circulatory Health Nattokinase

Bio Catalysts Immobilized Cal B

Digestive Aids Alpha amylase / fungal diastase / fungal amylase Alpha galactosidase Bacterial alpha amylase Bromelain Hemicellulase Lactase Lipase Ox bile

Papain Pepsin Pancreatin Protease ( acid / alkali)

Advanced Enzyme Technologies Limited Sun Magnetica, 'A' wing, 5th Floor, Accolade Galaxy, LIC Service Road, Louiswadi, Thane(W) - 400604, India Tel: +91 22 41703200, Fax: +91 22 25835159 • E-mail : info@enzymeindia.com • Website: www.enzymeindia.com

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Non-GMO ISO CERTIFICATION

GOTS CERTIFICATION

Products

WHO cGMP

FDA

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Product Range

Parksan Filters Pvt. Ltd.

Horizontal Plate Filter Press Plate & Frame Filter Press Bag Filter Cartridge Filter Single Plate Filter Holder Basket Filter Rotary Spray Ball Recess Plate Filter Press

103, Laxmi Industrial Estate, Navghar, Vasai Road (East), Dist. Thane - 401 210, India Tel : +91 250 239 1904 Mob : +91 98338 83114 Email : sales@parksanfilters.com Web : www.parksanfilters.com parksan@vsnl.net

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Environmental Monitoring • Particle Counting • Microbial Sampling • Real-Time Microbial • Validation & Compliance • Training & Education • Service & Calibration

Viable and Non-Viable. Together. Validated.

Particle Measuring Systems, U.S.A P-MEC 2013

FT4 Powder Characterisation Systems

Stall No : L29 Hall : 5 Date : 03-05 December, 2013 Venue : Bombay Convention & Exhibition Centre, Goregaon, Mumbai

PHARMAceutical EXPO 2013 (IPC) • • • •

Stall No : 35 Hall : B Date : 20-22 December, 2013 Venue : Amity University, Noida, Delhi NCR

For further information, please contact us:

E-mail: delhi@aimil.com

Tel: 91-11-3081 0244

www.aimil.com

Offices at : • Delhi (H.O.) • Mumbai • Bengaluru • Kolkata • Chennai • Vadodara • Hyderabad • Chandigarh • Guwahati • Bhubneswar • Indore • Lucknow • Kochi

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Aimil/Ad/A&I/13-14/11/31

Freeman Technology Ltd., U.K.

• 7 Different Tests to Characterise Powders • Flowability • Bulk Density • Shear Cell • Aeration & many more...

• • • •

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CLEANING, SANITISING EQUIPMENTS CLEAN ROOM ACCESSORIES ASEPTIC PIPING , PW / WFI DISTRIBUTION LOOPS

Floor Drain Traps

Hand Sanitiser

Water Saver Cleaninng Nozzles(self-rotating) Nozzles

Shoe Cover Dispenser

Foot Sanitiser

Split Butterfly Valve

Pendents(Service Shafts) CIP/ SIP MODULE We also design & manufacture # IBC Washing/ Drying Modules # Containers/ Glass Ware Wash Modules # FBD Bag Washing/ Drying Modules # Cannisters Washing Modules # Drums Washing Modules

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Wash Down Hose Station

SIP MODULE

8/B, Surat Singh Est ,SV Rd, Jogeshwari(W), Mumbai-400102 Tel; 022-26797941 Telefax:022-26798066 Cell: 9869231815 email: iewi@mtnl.net.in website : www.iewi.net

Top Tank / Reactor Sampler

Flush Bottom valve

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DMF NO: 26710

1 1 1 1 1 1 1 1 1 1 1 1 1

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US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free Imported state of the art machine ed Highly advanced auto-curing system rtifi e C Excellent heat resistance (-50째C to 250째C) m nroo Clea Odourless Completely nontoxic Repeatedly autoclavable No leaching of particles Does not support bacteria growth Retains elasticity even after prolonged use

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TABLETS SOFTGELS HARDGELS INJECTIONS ORAL DRY POWDER SACHETS ONCOLOGY ORAL LIQUIDS NUTRACEUTICALS CREAMS/LOTIONS SOAPS VETERINARY

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CLEANROOM SOLU TIONS Because, the whole is greater than the sum of its parts

E L E C T R I C AL SYSTEMS

I

N O G N

COM ALL MIS AT SIO I N

DESIGN

ENGINEERING

SUPPLY

IPMENT EQU

TURNKEY PROJECTS M

UTILITIES

G

CLEA N

MANU RO FAC O TU M R

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EN

L AI ING ET ER D INE

BMS LSS

STAND 41 M81

T UR N KE Y P ROJE CTS

AN

H VA C

We understand your needs when it comes to cleanroom projects

T EC OJ MENT PR AGE

CLEANROOM SYSTEMS

INS T

201, Sri Vensai Towers Varuna Block, Kompally Hyderabad – 500014 Andhra Pradesh, India

Phone: Fax: E-mail:

We understand Cleanroom Projects with Turnkey responsibilities better than most. With over 10 years of manufacturing experience, with over 600 projects commissioned across 15 countries worldwide,we understand your needs better. When it comes to project integration, we’ll let out our secret We take care of it at our design table.

+91-40-27165311/ 5316/ 5850 +91-40-30995267 info@icleantech.com

22-24 October 2013, Messe Frankfurt Germany

CLEANROOM PARTI TI ONS HV AC CLEANROOM EQUI PMENTS LAB FURNI TURES TURNKEY PROJECTS

www.icleantech.com O l ov i D e s i no G r a f i c o | krissy@olovi.net

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UNIPACK MACHINES PVT. LTD. UMP

AN IS/ISO 9001:2008 Certified Company

UNIPACK UNIPACK LAUNCHES ITS LATEST NEW PRODUCT POLYPROPYLENE PLATE & FRAME TYPE FILTER PRESS ANYTHING IN FILTRATION WE HAVE A SOLUTION

FOR LIQUID SOLID SEPARATION

FILTER PRESSES - FILTER PLATES

RECESSED (Chamber) Plates

POLYPROPYLENE Filter Plates & Frames

MEMBRANE Filter Plates

APPLICATION OF FILTER PRESSES Dyestuffs : Dyes, Dyestuff, Pigments, Intermediates for dyes etc. Chemicals : Basic Chemicals, Organic & Inorganic Chemicals, Phosphoric Compounds, Agro Chemicals, Pesticides and Others. Food Industry : Food Colours, Starch & Glucose, Fruit Juice, Squashes, Edible Oil, Palm Oil, Rice Bran & Glycerine. Mining & Metallurgy :Zinc, Copper, Nickel, Cobalt, Silver, Electroplating & Non Ferrous Metal, Mineral Concentration, Pollution:

Flotation tailings, Ceramic products and others. Effluent Treatment, Sewage Treatment, Industrial Waste Water Recycling, Sludge Dewatering Resulting from: Pickling Plants and galvanic plants, Industrial water and Potable water treatment plants, Dust scrubbers, Industrial sludge dewatering plants, Municipal sludge dewatering plants.

Redg. Off. 8 Krishna Mahal, 2nd Floor, ‘D’ Road Churchgate, Mumbai 400 020 Tel: +91 22 2281 2918 / 2281 0408 Works: Agarwal Ind Estate, No. 6, Unit No. 2, 3, 8, 9 & 10, Sativali Road, Village Waliv, Vasai (East ), 401 208 Dist Thane, Maharashtra INDIA Telfax: +91 250 2453 967 / 2455 449/ 2453 580 Email: ump1990@gmail.com. Website: www.unipackmachines.in EXPRESS PHARMA

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 COATING  Catch a COLOUR and we ll Match

it!

We manufacture NOVOMIX as per WHO-GMP standards

WHY USE NOVOMIX? NEPL has its own skilled technical team with more than 15 years of experience in the similar field, for it can be Formulation Development, Quality Assurance, Quality Control and Most Vitally COLOUR MATCHING. We are committed to provide total satisfaction to our clients in terms of quality, consistency, regulatory documents, after sales services etc. To fulfil these needs we will continuously work and excel ourselves to use latest technology and guidelines.

RANGE OF PRODUCTS:

US-DMF AVAILABLE

NOVOMIX - Plain Film Coating System NOVOMIX MR - Moisture Resistant Film Coating System NOVOMIX ENT - Enteric Film Coating System NOVOMIX GEN - General Film Coating System NOVOMIX SP - Special Film Coating System NOVOMIX TR - Transparent Film Coating System

Visit us at Stall No.: V121, Hall No.: 3

03-05 December 2013, Bombay Exhibition Centre, Mumbai, India.

For details please visit: Website: www.novomix.in E-mail: novomix@novoexcipients.com / marketing@novoexcipients.com EXPRESS PHARMA

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Your Quality, Our Assurance

Tablet Hardness Tester

Visit our Booth # E56, Hall ‘6’ 3rd - 5th December, 2013 Bombay Exhibition Centre, Mumbai.

EBT-2PL

H Hardness

speed

cGMP Thickness

Compliance (S.S. Body)

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800 Time

Constant speed

N

Force

Touch Screen

LAN

Print

sales@electrolabindia.com EXPRESS PHARMA


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Psychotropics India Limited

Excellent Manufacturing Facilities : Tablets, Capsules, Beta Lactams, Dry Syrups, Liquid Orals, Medicated & Cosmetic Soaps, Small Volume Parentals (Both General & Cephalosporin), External Preparations, Dusting Powders & Veterinary products (Bolus Tablets, Injections, Multivitamins)

WHO GMP Compliant Plants

Corporate Office : A-32, DLF, Sector-11, City Faridabad, State Haryana-121006, India. Contact Person : Naresh Joshi, E-mail : naresh@psychoindia.com & Director : sid@psychoindia.com Ph. : 00-91(0)-129-2282691 Fax : 00-91-(0)-129-2296764, 0129-2226635. web site : www.psychoindia.com.

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Your Quality, Our Assurance

USP Apparatus 4 (Flow-Through Cell Dissolution Tester)

Visit our Booth # E56, Hall ‘6’ 3rd - 5th December, 2013 Bombay Exhibition Centre, Mumbai.

Compliance

Touch Screen

Programmable Protocols

www.electrolabindia.com

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Print Report

Automated Offline Sampling

sales@electrolabindia.com

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ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

Innovation is our culture… Identification and quantification of Organic process impurities by LC-MS/MS – GCMS/MS. Inorganic impurities by ICP-MS and A.A.S with Graphite furnace, IC Solvent impurities by GC-MS/MS and GC head space with MS.

Quality in our genes… Genotoxic impurity quantification Genotoxic Studies. 1. Sub chronic oral Toxicity 2. Bacterial Mutation Assay. 3. Micro Nucleus test 4. Bone marrow chromosome aberration test. Qualification of Impurities.

Degradation products Method Validations as per ICH Guidelines Extractable and Leachable studies INVITRO safety STUDIES Polymorphic studies by XRPD. Protein impurities by capillary Electrophoresis.

TECHNOLOGIES FOR IMPURITY PROFILE STUDIES

ACCREDITATIONS

SERVICES Formulation Development Microbiological Studies Biological Studies Pre Clinical Studies Analytical Research Bio-equivalence Studies Clinical Trials Dossier Preparation Preclinical Pharmacopoeial Services

USFDA registered cGMP control testing laboratory DSIR approved R & D Centre Drugs Controller General of India (DCGI) NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical Recognized by Bureau of Indian Standards Drugs Control Administration (A.P) Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC)

Data Management practices in SIPRA LABS are designed to ensure total integrity, security and fastest retrieval.

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018. Tel: 040-23802000, Fax: 040-23802005, Email:sipra@sipralabs.com web: www.sipralabs.com

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