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News about GMP/cGMP

2018-08-24

Update on Medicines Containing Valsartan from Zhejiang Tianyu

Following the suspension of the CEP – a certificate verifying that the quality of its valsartan meets European requirements – for Zhejiang Huahai in July 2018, a second Chinese company Zhejiang Tianyu has now lost its authorisation to manufacture the valsartan active substance for EU medicines.

 

According to the EMA, 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 N-nitrosodimethylamine (NDMA) in the valsartan produced by the Chinese company. The levels of NDMA found in the active substance produced by Zhejiang Tianyu are considerably lower than those found in the active substance from Zhejiang Huahai.

National medicines authorities within the EU are currently taking appropriate actions in their countries. Actions being taken, which are precautionary, include recalling and stopping the distribution of medicines containing valsartan from Zhejiang Tianyu.

EMA’s review of valsartan in relation to NDMA is continuing and the Agencyis working closely with the EDQM, international partners and national authorities in the EU.

Source:

EMA: Press Release

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