Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part II)
- 20 August 2018
- active substance, API, carcinogen, CEP, distribution, EDQM, EMA, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, recall, review, stopping, suspension, valsartan, Zhejiang Tianyu,
The company Zhejiang Tianyu is no longer authorised to manufacture the valsartan active substance for EU medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements.
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 (to check the current status of CEP, please click here).
We have already informed on our website that as part of the ongoing review of valsartan medicines, EMA has learnt that low levels of N-nitrosodimethylamine (NDMA) have been detected in the valsartan active substance manufactured by a second company, Zhejiang Tianyu.
National medicines authorities 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.
Source: EMA, EDQM