US FDA Scrutinizes Process Risks After Nitrosamines Found In ARBs
Executive Summary
There is a new focus in reviews and inspections where nitrosamines or other dangerous process-related impurities might form.
You may also be interested in...
NDMA In Ranitidine Risks Rerun Of Sartans Crisis
Regulators in North America and Europe are reacting to the discovery of the impurity NMDA in ranitidine, just over a year after similar impurities in sartan products led to a slew of recalls and withdrawals around the world.
Contamination In Common OTC Antacid Adds To FDA's API Impurity Concerns
FDA assessing contamination of Rx and OTC H2 blocker ranitidine to determine steps it should take. The contaminant, NDMA, is dangerous when consumed in large quantities, but has been found in H2 blockers at levels that don't pose a risk, FDA says.
US FDA Warning Letter Draws Indian Solvent Recycler Into Valsartan Crisis
Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.