Nitrosamines: deadlines extended

Nitrosamines: deadlines extended

Europe In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in blood pressure medicines known as ‘sartans’. This led to some product recalls and strict new manufacturing requirements for sartans, based on a regulatory...
Nitrosamines: deadlines extended

New Deadline for Risk Assessment on Nitrosamines

Europe Marketing authorisation holders (MAHs) are asked to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances. The MAHs were obliged to...