EMA Tells Firms To Evaluate OTCs For Carcinogenic Nitrosamines
Executive Summary
Firms operating in the EU given six months to evaluate all OTC drugs containing chemically synthesized APIs for presence of nitrosamines, a probable human carcinogen. The order from EMA comes with a review of ranitidine underway after nitrosamine NDMA was detected in a number of OTC and Rx drugs.
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