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Chinese Manufacturer of RU-486 Questioned on Practices
The sole supplier to the U.S. of RU-486 is embroiled in a scandal over its manufacturing practices, the New York Times reports this morning.
Shanghai Hualian, based in China, faces allegations of a cover-up after almost 200 patients were paralyzed or otherwise harmed after receiving methotrexate or cytarabin contaminated with vincristine during the manufacturing process. The company is the sole supplier to the U.S. of mifepristone (also known as RU-486), according to the Times story. Although the plant that manufactures mifepristone is an hour's drive away from the one that made the tainted drugs, the company official responsible for both plants, Gu Yaoming, "also met with the United States F.D.A. inspectors last May as part of the routine inspection of the plant that makes RU-486," the newspaper reports.
According to the Times, the FDA has refused, without explanation, to reveal whether the parent company, Shanghai Pharmaceutical Group, exports any other drugs to the U.S.
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Published in Physician's First Watch January 31, 2008
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