Some valsartan generic medicines coming from China being recalled across the EU

6 July 2018

The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company based in Linhai, China.

Now off patent, valsartan is the active ingredient of Novartis’ (NOVN: VX) former block-buster blood pressure drug Diovan, and is still much in use as part of the Swiss pharma giant’s newer combination drugs such as Entresto (sacubitril/valsartan).

The EMA review was triggered after the Chinese company detected an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active substance which it supplies to manufacturers producing some of the valsartan generic medicines available in the European Union.

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