EU places China's Zhejiang Huahai under increased supervision

Reuters) - European authorities are placing Zhejiang Huahai Pharmaceutical Co Ltd under higher supervision, the European Medicines Agency said on Monday, in 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, the regulator said on Monday.

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.

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.

EMA said on Monday low levels of a carcinogen have now also been found in irbesartan made by Aurobindo Pharma, with the supply in the EU of medicines containing irbesartan in EU being suspended.

National authorities in the EU are currently considering whether to recall medicines containing Aurobindo Pharma's irbesartan from pharmacies as a precaution, the regulator said here.

OCTOBER 15, 2018

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