Information on N-nitrosamine impurities (N-nitrosamine impurities) in medicinal products

Since 2018 there has been discussions of a problem related to the presence of N-Nitrosamine impurities in medicinal products containing chemically synthesised Active Pharmaceutical Ingredients (APIs). In this regard the EMA (European Medicines Agency), WHO (World Health Organisation) and the FDA (U.S. Food and Drug Administration) have stated their opinions on mandatory measures that MAHs should take.

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