Jiangxi Boya Bio-Pharmaceutical Disputes Responsibility In Drug Deaths
This article was originally published in PharmAsia News
China's State FDA is overseeing the investigation of six deaths last month caused by the human immunoglobulin manufactured by Jiangxi Boya Bio-Pharmaceutical. The drug maker, which obtained China's GMP authentication in 1998, has identified the drug batch in the incident. To date, 9,575 doses of the batch were sold, of which 3,192 had been used and the rest recalled. The company asserts that the drug's production process is in order and it has not received any notice from the authorities to stop production. It also stresses the stringent requirements for storing such a perishable product and is confident there is no issue of expiry. The Jiangxi province police are investigating whether any law-breaking activities happened in the distribution chain. (Click here for more - Chinese Language)
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Jiangxi Boya Bio-pharmaceutical, the manufacturer of the human immunoglobulin that caused six deaths last May (PharmAsia News, Jun. 9, 2008), has resumed its drug production and sales. Company inside sources confirmed that the product has been selling for some time, but only for wholesale business due to very small production output. An official at Jiangxi FDA revealed he has received information that Boya is not linked to the deaths but no formal report has been released. However, a State FDA spokesman stressed that the agency has not issued any such statement. (Click here for more - Chinese Language)
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