US FDA Scrutinizes Process Risks After Nitrosamines Found In ARBs
There is a new focus in reviews and inspections where nitrosamines or other dangerous process-related impurities might form.
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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.
Lantech’s solvent recovery operations expected to meet US drug GMP requirements due to risk of carcinogens in blood pressure medications.