EMA Reviews Product from China Facility

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The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

On July 5, 2018, the European Medicines Agency announced that it was reviewing products containing the API valsartan supplied by Zhejiang Huahai Pharmaceuticals in Linhai, China after N-nitrosodimethylamine (NDMA) was detected by the company. National authorities in the European Union are recalling drugs containing the affected API.

According to EMA, the presence of the NDMA, which is a probable human carcinogen, is thought to be related to a change in manufacturing processes. The agency’s Committee for Medicinal Products for Human Use (CHMP), is reviewing the possible impact of NDMA on patients and what steps can be taken to eliminate the impurity from future batches of product.

Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack, and heart failure. 


Source: EMA