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Sandoz GMP Warning Letter: Is The Problem Documentation, Or Leadership?

This article was originally published in The Pink Sheet Daily

Executive Summary

Upper management at Novartis and Sandoz are responsible for repeated cGMP violations at three Sandoz plants, FDA suggests. The agency’s warning letter, aimed at three sites in North Amercia, includes what may become new biolerplate instructions on drug shortages.

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Originally expected back online by the summer, the Novartis Consumer Health facility in Lincoln, Neb., will not ship any product in 2012. Novartis, which reported consumer sales down 22% to $938 million in Q3, is using third-party manufacturers to restore Excedrin Migraine and other OTCs to market.

Novartis Turns To OTC Co-Packers As Lincoln Plant Lags

Originally expected back online by the summer, the Novartis Consumer Health facility in Lincoln, Neb., will not ship any product in 2012. Novartis, which reported consumer sales down 22% to $938 million in Q3, is using third-party manufacturers to restore Excedrin Migraine and other OTCs to market.

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