The Quality Lowdown: The More Things Change …
FDA on Zhejiang Huahai valsartan; EMA on Hetero Drugs and other sartans; Micro brew lab; Fagron API; FDA's Mexican soap aria
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
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.