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Impure valsartan API prompts recalls in EU

Executive Summary

Hundreds of marketing authorisations held by major generics players – including Accord’s Actavis, Aurobindo, Gedeon Richter, Sandoz, Sanofi’s Zentiva, and Teva – have been affected by recalls across Europe of medicines containing valsartan, prompted by the discovery of an impurity in the active pharmaceutical ingredient (API) supplied by China’s Zhejiang Huahai. Health Canada has also issued a recall.

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