www.fdca.guj.nic.in

Food and Drugs Control Administration (FDCA), Gujarat plays important role in enforcement of “Drugs and Cosmetics Act 1940 & Rules” and enforcement of : “Food Safety and Standard Act, 2006” and Rules in Gujarat State. It plays pivotal in Pharma and medical devices sectors in Gujarat to make the state a favorable investment destination towards inclusive development and growth. It has played a vital role in the implementation of egovernance in FDCA and is winner of one state level and three national level awards.

www.lubrizol.com

Specialty Materials To Deliver Application Specific Solutions To Medical Device, Pharmaceutical, Healthcare & Food Industries.

Lubrizol LifeSciences is a healthcare product solution partner for medical and pharmaceutical manufacturers who need product development support and drug eluting device solutions.

Exceptional healthcare products with proven performance begin with the polymer technology of Lubrizol LifeSciences medical device solutions. Lubrizol works with you to create functional polymer solutions for various medical applications. Key product brands Pellethane® TPE, Tecoflex™ TPU, Tecothane™ TPU, Isoplast® ETPU and Carbothane™ TPU.

Now with Vesta and Particle Sciences - LifeSciences is the only healthcare product solution partner offering comprehensive polymer, formulation and manufacturing capabilities that provide polymer customization, complex drug formulation and contract
manufacturing solutions.

Lubrizol LifeSciences has significantly expanded our capabilities through new products, state-of-the-art facilities, acquisitions and alliances. With this unique combination, Lubrizol LifeSciences delivers comprehensive medical solutions, including to the drugeluting device product market.

Contact Details:
Mr. Mittal Shah - Head Strategy and Business Development
Lubrizol Advanced Materials India Pvt. Ltd.
Application & Business Center, 6th & 7th Floor, Jaswanti Landmark,
Mehra Industrial Estate, LBS Marg, Vikhroli (W), Mumbai - 400079
P: +91 22 6602 7800 M: 9167702682. Fax: +91 22 25778486
Mittal.Shah@Lubrizol.com

www.pradeepsurgipack.com

Manufacturing Medical Grade Sterilization Packaging Products.

Pradeep Surgipack is in the business of manufacturing medical grade sterilization packaging products which are used to pack medical devices which are to be sterilized. Pradeep Surgipack is an ISO 9001:2008 & ISO 13485:2003 Certified Manufacturing Company and its products are certified to EN Standards for Medical Devices. Pradeep Surgipack’s range of products includes, Medical Grade Peel- Open Pouches and Reels which are compatible with Steam, EtO, Gamma & Plasma Sterilization processes. The pouches and reels are made of a variety of substrates like, Uncoated Kraft Papers, Coated Papers, Reinforced Papers, Grid Lacquered Papers, and Tyvek etc which are sealed on to variety of Laminated Films of Poly Propylene, Polyester and Polyethylene.

Contact Details:
Mr. Pradeep Rao
Pradeep Surgipack
3-A , Sarakki Industrial Estate, J.P. Nagar 3rd Phase,
Bannerghatta Road, Bangalore - 560076. P: 080 – 26586254
M: 9880723272
E: pradeep.surgipack@gmail.com

www.elastomer-technik.com

Medical Moulded Parts For OEM's From Liquid Silicone Using The Highest Medical-Grade Materials.

ET Elastomer Technik GmbH was founded 1992 in Lauffen am Neckar / South Germany.

The company started injection moulding of joints and gaskets. In 1994 ET had its first big success in producing a breathing bag out of Liquid Silicone Rubber. From there on ET Elastomer Technik was known in the market and worked close to the medical and automotive industry, where silicone could push the boundary of other Elastomers.

In 1996 the production capacities of the plant in Lauffen am Neckar where too small and ET found a bigger production site in Ellhofen / Germany. In this new Factory, ET also begins the facilities for the manufacturing of long term implants. One of their first projects was a larynges implant for people who suffered from ‘Mustard Gas’ attacks during the gulf war. Since then ET started a wide range of different implants.

In 2004 ET decided to start a second plant in Hammelburg/Germany. Here they brought in a new idea of production: each industry has its own production facility. A clean room class 8 as well as a tool shop was installed in 2006 and 2 years later they established the ISO 13485.

In 2010, ET Elastomer Technik GmbH have started their production facility at Gandhinagar, Gujarat under the name of “ET Elastomer Technik India Private Limited.

Now ET Elastomer Technik GmBH has everything to meet the demands of its customers ET Elastomer Technik GmbH is specialised in manufacturing silicone medical products using the highest medical-grade materials, meeting US FDA requirements with quick development and turnaround.

Products include a wide range of O-Rings and moulded shapes for short- and long-term implantation. Complete product assembly services are offered with on-site clean room and tool shop.

• ET provides custom-made silicone products and solutions for a wide range of industrial applications and consumer needs

• Serving globally active customers from various industries, including medical engineering, automotive, and electronics, we have become a trusted partner of choice for the timely and reliable development of high-end items

• ET provides custom-made silicone products and solutions for a wide range of industrial applications and consumer needs

• Serving globally active customers from various industries, including medical engineering, automotive, and electronics, we have become a trusted partner of choice for the timely and reliable development of high-end items.

Contact Details:
Germany Office:
ET Elastomer Technik GmbH
Abtsäckerstraße 16, 74248 Ellhofen,
Tel.: +49 (0)9732/ 78865 – 12, Fax:+49 (0)9732/ 78865 - 18
info@elastomer-technik.com

India Office:
ET Elastomer Technik India Private Limited
B 183-184 GIDC Electronic Estate,
Sector 25 Gandhinagar- 382024
Ph: +91 79 23287624, M: +91 97277 63274
info@elastomer-technik.in

www.maiderchina.com

Sterile Medical Automation Equipment

Maider is a national leading hi-tech enterprise in the field of automation, engaged in developing and manufacturing of sterile medical automation equipment, to provide optimum automation solutions for customers. Our main products are I.V. set automatic assembly equipment, Syringes automatic assembly equipment, Dailyser automatic assembly equipment, Blood series automatic assembly equipment and etc.

Contact Details:
Qiyu Chen
No. 3 Tianyou Load, Bingang Industry City, Yuhuan County,
Zhejiang Province,
P. R.China.- 317608 P: 86-576-87498999, F: 86-576-87110008,
M: 86-18057668205 E: sales@maiderchina.com

www.shriramaxiall.com

Medical Grade PVC Compounds in India with world class manufacturing facility.

In 2014, DCM Shriram Ltd., had entered into a 50/50 Joint Venture Agreement for its Polymer Compounding business with Axiall Corporation, a North American manufacturer of Chloro-Vinyl, Aromatics and Building Products. Shriram Axiall is now one of the largest organized players for PVC compounds in India and has been present in the medical segment for more than 45 years.

Shriram Axiall manufactures Engineered Vinyl Compounds which finds applications across multiple medical devices. All compounds are safe to use (phthalate free) and comply with global standards (Ideal for Exports). The medical grades adhere to Indian standards as well as biological tests prescribed under USPXXI. The compounds are manufactured in state of the art class 100,000 facility conforming to GMP requirements. Shriram Axiall supplies India's leading OEM's for disposable medical devices.

Some of the key products by Shriram Axiall are :

• Clear Extrusion - USP Class 6 Material for Tubes, Flexible tubes for IV sets, Catheter Tubing, Cardio Vascular Tubes

• Clear Injection Moulding - Oxygen Mask, Drip Chamber, Connec tors

• Rigid Injection/Blow Moulding - Connectors, Small Bottles, Five Gallon Bottles, Suction Handle, Veterinary Tubes


Contact details:
Shriram Axiall (Formerly Shriram PolyTech)
2nd Floor, Plot No. 52, Sector 32, Institutional Area,
Gurgaon – 122 003, Haryana, India.
Phone +91 124 4632100
info@shriramaxiall.com

www.saitreat.com

Water treatment and commercial water purification systems.

SAI-TREAT is a leading manufacturer and wholesale distributor of water treatment and commercial water purification systems since 1989. Since the last 26 years, We have offered a wide range of pre-engineered as well as custom engineered solutions for all water purification needs of the customers.

We offer a wide range of products ranging from domestic water purifiers to advanced waste water treatment plants.

Contact Details:
Ninad Sankhe
Anandi Specialities & Services Pvt. Ltd.
175, V-Mall, 1st Floor, W. E. Highway,
Near Sai Dham, Thakur Complex, Kandivali (E),
Mumbai - 400 101. (INDIA).
Tel.: +91 22 4297 4397. Fax.: +91 22 2854 2480
sales@saitreat.com

www.ldra.com

Testing Tools for IEC 62304/FDA Compliance Training & Consulting

For more than forty years, LDRA has developed and driven the market for software that automates code analysis and software testing for safety-, mission-, security- and business-critical markets. Working with clients to achieve early error identification and full compliance with industry standards, LDRA traces requirements through static and dynamic analysis to unit testing and verification for a wide variety of hardware and software platforms.

Boasting a worldwide presence, LDRA is headquartered in the United Kingdom with subsidiaries in the United States and India coupled with an extensive distributor network.

Contact Details:
LDRA Technology Pvt. Ltd
#2989/l B, 3rd Floor, 12th Main, HAL II Stage,
Bangalore -560 008. Ph: +91 80 4080 8707. Fax: +91 80 4204 3186
Email: india@ldra.com

www.fitcoindia.com

Plastic Testing Equipments

Federal India Trading Company represents reputed Testing Equipments manufacturers from USA, UK and Europe. We are in this business for over 45 years.

We not only supply products but provide installation, training on operation of the equipment, calibration and complete after sales services.

We represent Dynisco, USA, Systech, UK, Testometric, UK, Carver, USA, Wabash, USA, KOPP, Germany. We offer Melt Flow Index Tester, Capillary Rheometer, Universal Testing Machine, MFI Tester, Tensile Tester, Gaspace Analyzer, WVTR Tester, OTR Tester, Friction Tester, Sealing Tester, Headspace Analyzer, COF Tester, Hot and Cold Tack Tester, etc.

Contact Detail:
Mr. Mehul P.Javeri
Federal India Trading Company,
No.49/50, Jainnagar, Sukhipura Road, Paldi,
Ahmedabad 380007
P: 079-26620059, 26607020, F:079-26640002
E-mail: mehul.javeri@fitcoindia.com

www.excelformulations.com

State-of-the-art ETO formulation and bottling facility.

Established in 2007, Excel Formulations is amongst India’s leading manufacturers of ETO Gas mixtures. Company is ISO 9001 and D&B certified. They are manufacturing various types ETO gas mixtures in cylinders as well as Disposable E.O Cartridges. The company established a state-of-the-art ETO formulation and bottling facility at Sanand, Gujarat and supplies various combinations of Ethylene Oxide with Carbon Dioxide in different sized cylinders.

The plant that manufactures mixtures of ethylene oxide and carbon dioxide is manned by skilled team with a strong quality orientation. This ensures strict adherence to safety, health and environment standards at the plant. This in turn ensures that the products manufactured are reliable and are of the highest quality, all in keeping with our commitment towards excellent customer service.

Contact Details:
Mr. Dipesh Patel - Partner
401, Sanidhya- A, Opp. Anandnagar Shopping Center,
Prahladnagar 100ft. Road, Satellite, Ahmedabad-380015
Ph: +91-79-40067245, +91-9228008275
E: info@excelformulations.com