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US FDA Warns Torrent Over Losartan Process Validation, OOS Invalidation Failures

 
• By Bowman Cox

Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.

Vintage inscription made by old typewriter, warning
Letter is another sign of the increased scrutiny the valsartan crisis has brought to pharmaceutical manufacturers.

Torrent Pharmaceuticals Ltd. came under fire in an 8 October US Food and Drug Administration warning letter for failing to properly validate the use of an alternate active pharmaceutical ingredient in its manufacturing process for losartan potassium tablets.

The warning letter resulted from the agency’s ongoing global investigation into potentially carcinogenic nitrosamine impurities in valsartan and other...

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