The PTM response to nitrosamine presence
a risk-based approach for the nitrosamines evaluation for Marketing Authorization Holders In June 2018, authorities in the EU became aware of the presence of a nitrosamine, N-nitrosodimethylamine (NDMA), in valsartan from one manufacturer of active pharmaceutical ingredients (APIs). Subsequently another nitrosamine, N-nitrosodiethylamine (NDEA), was detected and other sartans from more API manufacturers were later implicated. NDMA and NDEA are classified as probable human carcinogens and their presence in sartans was,…