The Reaction To Valsartan Impurities: More Scrutiny, More Testing And Tighter Limits
Potent Carcinogens Stir Up Anxieties Over Unknown Unknowns In Pharmaceutical Process Chemistry
In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.
