As Recalls Multiply, EU Agency Studies How To Rid Chinese Firm’s Valsartan API Of Probable Carcinogen
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.
You may also be interested in...
How authorities plan to root out the carcinogenic impurities and what it means for other classes of medicines.
Why EU challenged Huahai’s valsartan quick fix, how FDA is making a lesson of Huahai, and what happens when examples like the Viracept recalls fade from memory – it’s all in this week’s Lowdown. Plus how Atlas is purportedly assuring sterility on Carefree Highway, and what happened when Sun used out-of-specification exhibit batches.
US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.