IHS Chemical Week

EnviroTech :: Regulatory

USP Adopts New Manufacturing Controls for Heparin

1:56 AM MDT | October 2, 2009 | Deepti Ramesh

The United States Pharmacopeia (USP; Rockville, MD), a standards-setting organization, adopted new manufacturing controls for anti-clotting drug heparin, to ensure the quality of heparin and to guard against potential contamination, the U.S. FDA says. This follows several incidents of contamination of heparin in 2008. The FDA was criticized last year for its failure to inspect a plant in China that manufactured the API for heparin, which was cited as the cause of deaths and harmful effects in some U.S. patients. The revised standards for heparin are contained in...

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