Torrent Pharma in FDA’s Sights Over Nitrosamine Contamination

October 28, 2019

The FDA named Indian drugmaker Torrent Pharmaceuticals as a target of its investigation into nitrosamine impurities and issued the company a warning letter for repeat violations at its Indrad, Gujarat plant.

The agency criticized management oversight and control over manufacturing operations, flagging multiple failures at multiple sites, and said the violations led to nitrosamine impurities and subsequent recalls.

Torrent manufactures losartan potassium tablets and is part of “an ongoing global investigation” into nitrosamine impurities in angiotensin receptor blockers such as valsartan, losartan and irbesartan.

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