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SABIC Plants in Brazil and Argentina Earn Certification to Produce FDACompliant, Biocompatible resin
SABIC’s Innovative Plastics business today announced that its manufacturing facilities in Campinas, Brazil and Tortuguitas, Argentina, are now certified to produce U.S. Food and Drug Administration (FDA)-compliant and biocompatible resins
“With biocompatible and FDA-certified resin production now in place in our Brazil and Argentina plants, in addition to the United States, Europe and Singapore, we are well positioned to meet the local supply needs of healthcare device manufacturers worldwide who have production facilities here in South America,” said Ricardo Knecht, general manager, South America, Innovative Plastics. “SABIC continues to proactively invest in local capabilities that benefit our customers. Our broad and deep portfolio of healthcare materials, together with value-added services such as custom color matching and technical support, offers a critical competitive advantage in the rapidly changing and highly competitive medical products sector.”
Local Resin Supplies Accelerate Time to Market
With the certification of the two SABIC facilities, medical device manufacturers and other healthcare customers can rely on local sources of supply instead of having to wait for imports to arrive. The lead time for SABIC FDA and biocompatible resins in the region is expected to drop dramatically, helping customers accelerate time to market for their products. With local production of healthcare grades, manufacturers can avoid delays, cut inventory costs because they no longer need to stockpile resin, and enjoy greater flexibility in ordering materials. In addition, customers can now be confident about expanding their use of SABIC healthcare materials in new applications, knowing that they have a reliable local source of supply backed with local expertise, technical support and SABIC’s healthcare product policy.
Local Supply and Support Backed By Healthcare Product Policy
SABIC proactively developed an industry-leading healthcare product policy to simplify regulatory compliance during marketing approval and throughout the device lifecycle. Materials included under the policy have been assessed for biocompatibility, are covered by an FDA Drug or Device Master File, and are subject to formula lock and a stringent change management process. The policy gives customers the comfort of knowing that SABIC is able to lock the formula and have a supply plan in place in the event of change. Pre-assessing biocompatibility helps speed up marketing approval in the regulatory process, while internal controls and change management help assure consistent quality and reliability of supply.
For additional information on SABIC’s healthcare product portfolio and healthcare product policy, please go to www.sabic-ip.com. For technical product inquiries, please contact us at www.sabic-ip.com/
About Saudi Basic Industries Corporation
Saudi Basic Industries Corporation (SABIC) ranks among the world’s top petrochemical companies, and is a global market leader in the production of polyethylene, polypropylene, advanced thermoplastics, glycols, methanol and fertilizers. SABIC manufactures with a global footprint in Saudi Arabia, the Americas, Europe and Asia Pacific. The company operates in more than 40 countries across the world with 33,000 employees worldwide. It has significant research resources with 18 dedicated Technology & Innovation facilities in Saudi Arabia, the USA, the Netherlands, Spain, India and China. SABIC recorded a net income of SR 21.59 billion (US$ 5.73 billion) in 2010, and sales revenues totaled SR 152 billion (US$ 40.5 billion).
About Innovative Plastics
The Innovative Plastics business unit of SABIC is a leading, global supplier of engineering thermoplastics with an 80-year history of breakthrough solutions that solve its customers’ most pressing challenges. Today, Innovative Plastics is a multi-billion-
* Trademarks of SABIC Innovative Plastics IP B.V.