As Recalls Multiply, EU Agency Studies How To Rid Chinese Firm’s Valsartan API Of Probable Carcinogen

20 Jul 2018

European authorities are examining how a manufacturing process change six years ago may have introduced a probable carcinogen into Zhejiang Huahai’s valsartan API that was only recently detected. They hope to learn how the firm could reduce or eliminate the impurity.

A worker examines a chemical raw materials tank

A probe underway in the EU could uncover how a blood pressure medicine’s active pharmaceutical ingredient has been contaminated by a probable carcinogen for as long as six years, with lessons not only for the API supplier in China, but also perhaps for others who supply that API or who use similar manufacturing processes, and for their customers.

As customers of Zhejiang Huahai Pharmaceuticals Co. Ltd., Linhai, China, recall tablets made with its valsartan API from markets...