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Chinese Antihypertensive Drug To Go International

This article was originally published in PharmAsia News

Executive Summary

Beijing Second Pharmaceutical started bioequivalence trials on its amlodipine benzenesulfonate tablets in the U.S. last December, a significant step toward procuring current good manufacturing practices audit and registration in the market. Amlodipine benzenesulfonate constitutes the top-ranking antihypertensive drug in China and the world, with Beijing Second Pharmaceutical enjoying the biggest local market share in annual sales. The company's product is expected to obtain FDA's abbreviated new drug application approval in 2009, making it the first-ever China-produced amlodipine export to the U.S. (Click here for more)



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