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Simcere Passes EU-GMP Inspection for OTC Diarrhea Treatment

publication date: Aug 23, 2011
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Simcere Pharma reported that Biqi, the company’s branded generic anti-diarrhea drug, has passed EU-GMP inspection. The certificate was issued following an audit that covered product formulation, manufacturing process, facilities and quality management systems. In 2010, Simcere's manufacturing facility for diosmectite, the API in Biqi, successfully passed EU-GMP inspection. Simcere makes innovative cancer treatments and branded generics, all of which are distributed in China. Simcere should now be able to market Biqi in Europe, though it did not announce any plans to do so. More details....

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