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US FDA Questions Valisure’s Zantac Carcinogenicity Findings

Executive Summary

As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.

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Valisure Will Continue As 'Inconvenient' Reminder For Change To US Drug Quality ‘Status Quo’

“I think the symptoms of the core disease of quality is not having an independent layer or just not being able to invest more in quality or whatever the other root causes of addressing these quality issues,” says analytical lab president David Light.

USP Proposes Analytical Methods For Drug Makers To Detect Nitrosamine Impurities

The USP has launched an initiative to address the nitrosamine crisis by proposing a new general chapter that outlines a set of analytical methods that manufacturers can use to demonstrate their products are free from unsafe levels of these potential carcinogens. The chapter is aligned with the FDA’s guidance on nitrosamine impurities.

More Recalls Seen For Ranitidine

Sandoz is voluntarily recalling all ranitidine hydrochloride capsules in the US because of “confirmed’ NDMA contamination, while Dr Reddy’s is suspending global shipments of the generic version of Zantac due to worries about the presence of the suspected cancer-causing agent in its products, as suppliers around the world grapple with the issue.

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