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FDA Discusses Manufacturing Processes In ARB Medicines Impurities Update

Manufacturers using processes at risk for impurities in ARB medicines are expected to complete tests to ensure that active ingredients and finished products are free of detectable levels of nitrosamine impurities, the FDA has directed.

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FDA's investigations point to changes in manufacturing processes potentially leading to impurities • Source: Shutterstock

Manufacturers using processes that risk impurities in angiotensin II receptor blocker (ARB) medicines should complete further testing to ensure their products are free of detectable levels of nitrosamine impurities, the US Food and Drug Administration (FDA) has stated.

FDA Commissioner Scott Gottlieb and director of the agency’s Center for Drug Evaluation and Research (CDER) Janet Woodcock have released a statement providing an update on the agency’s ongoing investigation into generic versions of ARB medicines containing nitrosamine impurities, that largely centres around manufacturing processes

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