Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA

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 N-nitrosodimethylamine (NDMA) in the valsartan produced by the Chinese company.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

The levels of NDMA found so far in batches of valsartan from Zhejiang Tianyu are considerably lower than levels found in the active substance from Zhejiang Huahai, which triggered a recall of several valsartan medicines in July 2018. The certificate for Zhejiang Huahai had already been suspended and the company is also not permitted to supply valsartan active substance to the EU.

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. For further information, contact the relevant national authorities.

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

The EDQM is a Directorate of the Council of Europe created in 1964 which sets standards for the quality of medicines and their active substances in European countries.

EDQM is in charge of issuing CEPs, which manufacturers can use to demonstrate that the quality of their active substance is suitably controlled and complies with European regulatory requirements. More information about the procedureExternal link icon for issuing CEPs is available on the EDQM website.

Posted on the EMA website on 20 August 2018