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Simcere Receives SFDA Approval to Manufacture and Sell Zanamivir in China

By Pharmaceutical Processing | February 11, 2010

Simcere Pharmaceutical Group, a pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that one of its subsidiaries, Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd., has received new drug registration approval from the State Food and Drug Administration (“SFDA”) to manufacture and sell Zanamivir, a neuraminidase inhibitor inhalant used in the prevention and treatment of Influenza A and Influenza B. Zanamivir is marketed globally by GlaxoSmithKline under the trade name Relenza.

Zanamivir is one of only two WHO approved drugs to which the new H1N1 strain of influenza A has been shown to be susceptible. GlaxoSmithKline granted a license to Simcere in 2006 to manufacture and sell Zanamivir and its formulations in China. Simcere is the only pharmaceutical company in mainland China that has such a license.

Mr. Jinsheng Ren, Chairman and Chief Executive Officer of Simcere Pharmaceutical Group, commented, “We are delighted to receive SFDA approval to manufacture and sell Zanamivir, which has proved very successful in the fight against the H1N1 strain of Influenza A. With our leading domestic manufacturing facilities, well-known brand and nationwide marketing platform, Simcere is well prepared to bring this exciting drug to China.”

 

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