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news.Simcere Pharmaceutical (Simcere) has announced that one of its subsidiaries, Nanjing Simcere Dongyuan Pharmaceutical, has received new drug registration approval from the State Food and Drug Administration (SFDA) in China. The clearance is to manufacture and sell Zanamivir, a neuraminidase inhibitor inhalant used in the prevention and treatment of influenza A and influenza B, in the country.
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Zanamivir is marketed globally by GlaxoSmithKline (GSK) 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. GSK granted a license to Simcere in 2006 to manufacture and sell Zanamivir and its formulations in China.
Jinsheng Ren, chairman and chief executive officer of Simcere, said: “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.”