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Zhejiang Huahai Pharmaceutical tablet application receives FDA clearance

February 22, 2019


Abstract : Zhejiang Huahai Pharmaceutical Co., Ltd. (600521.SH) announced Friday that its abbreviated new drug application (ANDA) for 50mg doxycycline hydrochloride sustained-release tablets had gotten the approval of the U.S. Food and Drug Administration (FDA ).

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BEIJING, Feb. 22 (Xinhua) -- Zhejiang Huahai Pharmaceutical Co., Ltd. (600521.SH), a large scaled modern pharmaceutical group in east China's Zhejiang Province, announced Friday that its abbreviated new drug application (ANDA) for 50mg doxycycline hydrochloride sustained-release tablets had gotten the approval of the U.S. Food and Drug Administration (FDA ).

Doxycycline hydrochloride sustained-release tablet is a type of broad-spectrum antibiotics.

The approval qualifies the company to produce this kind of tablets and sell them in the U.S. market which will help the company to expand its overseas market, according to the company's filing to the stock exchange.

It is noted that the company has invested around 3 million yuan in related research and development (R&D) of the 50mg doxycycline hydrochloride sustained-release tablets. (Edited by Gu Shanshan)

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Keyword: pharmaceutical Zhejiang FDA

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