Date
13 November 2018
European Medicines Agency (EMA) has placed China's Zhejiang Huahai Pharma under tighter supervision in relation to manufacturing practices. Photo: Bloomberg
European Medicines Agency (EMA) has placed China's Zhejiang Huahai Pharma under tighter supervision in relation to manufacturing practices. Photo: Bloomberg

China drug maker placed under increased supervision by EU

European authorities announced on Monday that they are placing Zhejiang Huahai Pharmaceutical Co. under higher supervision, marking the latest crackdown on the Chinese firm after a probable carcinogen was found in its blood pressure drug valsartan.

EU authorities will now supervise the manufacture of other active substances produced by Zhejiang Huahai more closely, Reuters reports, citing the European Medicines Agency.

European authorities said late last month they had found that Huahai did not comply with good manufacturing practices and that the company’s factory in Linhai, China, was no longer authorized to produce valsartan.

The bulk manufacturer of the high blood pressure drug recalled the product in the United States in July after an impurity linked to cancer was detected, the report noted.

European and North American regulators last month found a second toxin in Valsartan that may cause cancer in humans.

The review was extended to other ‘sartan’ medicines, including candesartan, irbesartan, losartan, olmesartan and valsartan, after very low levels of a carcinogen was found in losartan made by Hetero Labs in India.

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RC

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