About this document
Nitrosamine Impurity Guidance for ARBs by Mayur Jadhav is a document available to read on EtoBox.
This letter from the FDA informs ARB drug applicants and holders of related drug master files about concerns regarding toxic nitrosamine impurities found in some ARB drugs. It summarizes FDA findings to date and provides recommendations for testing ARB drug products, APIs, and raw materials to ensure they are free of these impurities. Manufacturers are advised to test samples, report any positive findings to the FDA, and recall products exceeding interim limits for nitrosamines. The FDA aims to prevent dist
- Author
- Mayur Jadhav
- Language
- EN