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Simcere Pharmaceutical Receives First Generic Biapenem Certificate

This article was originally published in PharmAsia News

Executive Summary

Simcere Pharmaceutical Group's first generic biapenem drug has received new drug certificate and production approval from China's State FDA. A newly launched generic drug enjoys a four-year assessment grace period during which SFDA declines applications of similar chemical compounds or drug administration routes whose R&D has not entered into clinical stages. Biapenem, like Merck's Tienam and Dainippon Sumitomo's Mepem, comes under carbapenem antibiotics. The drugs have a 1.6 billion yuan market in China, with 30 percent annual growth over the past three years. Simcere believes that the biapenem's approval will enhance the firm's long-term strategy of focusing on first-to-market anti-infection generic drugs. (Click here for more - Chinese Language)

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