EMA withdraws authorization of Chinese valsartan product maker

20 August 2018

The Chinese company Zhejiang Tianyu is no longer authorized to manufacture the valsartan active substance for European Union medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements, the European Medicines Agency announced today (August 20).

The suspension of the certificate by the European Directorate for the Quality of Medicines and Healthcare (EDQM) comes after the detection of low levels of NDMA in the valsartan produced by the Chinese company. Valsartan is the active ingredient of Novartis’ (NOVN: VX) former block-buster blood pressure drug Diovan.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The US Food and Drug Administration has also taken action on this substance,

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