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FDA Warning Letter Could Impact Zhejiang Medicine’s US Foray

 
• By Ying Huang

Zhejiang Medicine has become the latest major Chinese API firm to be hit with a US FDA warning letter amid stepped up oversight of production facilities in China by the US regulator, which has led to a string of similar actions this year alone. But efforts are now being made both by Chinese manufacturers and by authorities in the two countries to ensure adherence to international standards.

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Zhejiang Medicine Co. Ltd. (ZMC), a major China-listed active pharmaceutical ingredient (API) and intermediates supplier, has taken action in response to a warning letter sent by the US Food and Drug Administration to one of its subsidiaries for concealing API test data and other irregularities, the company has disclosed.

ZMC said Xinchang Pharmaceutical Factory, a subsidiary that violated FDA current good manufacturing practice (cGMP) for APIs, sent the US...

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