EU Suspends Chinese API Supplier for Valsartan Products

The European Medicines Agency announced Monday that Chinese API manufacturer Zhejiang Tianyu is no longer authorized to manufacture valsartan active substance for EU medicines.

The European Directorate for the Quality of Medicines and Healthcare suspended the firm’s quality certificate after the detection of low levels of N-nitrosodimethylamine (NDMA) in valsartan produced by the company.

EMA said the levels of NDMA found so far in batches of valsartan from Zhejiang Tianyu were considerably lower than levels found in the active substance supplied by Zhejiang Huahai, which triggered recalls of valsartan products in the EU last month.

The certificate for Zhejiang Huahai had already been suspended and the company is also not permitted to supply valsartan to the EU.