Sartan Manufacturers Should Review Manufacturing Processes, Says EMA

February 6, 2019
Pharmaceutical Technology Editors

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

On Feb. 2, 2019, the European Medicines Agency announced that companies that make angiotensin II receptor blockers must review their manufacturing practices to prevent the production of products containing nitrosamine impurities, N-nitrosodimethylamine (NDMA) and N‑nitrosodiethylamine (NDEA). There will be a transition period of two years for companies to make manufacturing process changes with strict temporary limits on levels of these impurities. After this time, companies will have to demonstrate that their sartan products do not contain quantifiable levels of the impurities before they will be used in the European Union.

This requirement follows the discovery of NDMA and NDEA in some sartan medicines. After some investigation, it appears that these impurities may form during the production of sartans “that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used. In addition, it is possible that impurities were present in some sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process,” according to EMA.

Source: EMA