The FDA recently released its guidance on nitrosamine contamination and set deadlines for risk assessment updates and full compliance. This is an issue that affects no small portion of the industry: about 30% of approved active pharmaceutical ingredients (APIs) are susceptible to nitrosamine formation.
In this article, we discuss the guidance in detail, look at various approaches for reducing the presence of impurities, and demonstrate how Adare's unique nitrosamine mitigation process can help products achieve compliance.