Nitrosamine impurities – are you ready to fulfil your legal obligations as a MAH by March 26th, 2020?
During the summer 2018, authorities become aware of the presence of some nitrosamines in API – ( – presence of N- nitrosodimethylamine (NDMA) - other sartans – presence of N-nitrosodiethylamine NDEA). Nitrosamines are chemical compounds classified as probable human carcinogens…