Healthcare industry FDA Compliance for Biocompatible Resins in South America
Sabic now provides FDA compliant biocompatible resins for the South American healthcare industry. The company expects customers to profit from reduced time to market, speakers say.
Bergen/The Netherlands; Campinas/Brazil – Sabic was granted U.S. Food and Drug Administration (FDA) compliance for its biocompatible resins, produced in Campinas, Brazil and Tortuguitas, Argentina targetted at markets in South America. Medical markets in eight Latin and South American countries – Brazil, Mexico, Argentina, Chile, Venezuela, Peru, Colombia and Cuba – are expected to witness a compound annual growth rate (CAGR) of about 4.6 percent between 2008 and 2013, reaching U.S. $9.2 billion, says Espicom Health Intelligence.
“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 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 colour matching and technical support, offers a critical competitive advantage in the rapidly changing and highly competitive medical products sector.”
Faster Time to Market With Local Production
Now, with the certification of the two Sabic operations, medical device manufacturers and other healthcare customers can rely on local sources of supply – Sabic expects significantly shorter lead times for its FDA and biocompatible resins in the region, helping customers to reduce their time to market. But the comapny also sees other advantages: 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.
Customers Benefit From Health Care Policy
Furthermore, Sabic expects customers to profit from its healthcare product policy that aims 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.
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