The European Medicines Agency (EMA) has announced that it is reviewing valsartan produced by a second company. On Friday (10 August) it announced that, as part of its ongoing review into medicines containing valsartan, it had learned that low levels of N-nitrosodimethylamine (NDMA) were detected in the valsartan active substance manufactured by Zhejiang Tianyu.
The initial review was triggered after another company, Zhejiang Huahai Pharmaceuticals, detected NDMA in the valsartan active substance, which the company supplies to manufacturers producing some of the valsartan medicines available in the European Union (EU). National authorities across the EU are recalling medicines containing valsartan supplied by that company, while the review is underway.
The EMA said the levels of NDMA detected in batches of valsartan from Zhejiang Tianyu are "much lower" than levels seen in the active substance from Zhejiang Huahai. It stressed that there is no immediate risk to patients and said it is working closely with international partners to review the impact of the NDMA detected in valsartan from Zhejiang Tianyu and "will communicate as soon as additional information becomes available".
A list of medicines containing valsartan from Zhejiang Tianyu will be available from national medicines authorities.