GMP Warning Letter: Teva Preempts FDA In Disclosing Problems At Jerusalem Plant
Executive SummaryGeneric giant Teva took the unusual step of disclosing the entire contents of a Jan. 31 FDA warning letter about good manufacturing process failings, as part of a Securities and Exchange Commission filing it posted online two days later.
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Teva’s new CEO, Jeremy Levin, has been emphasizing manufacturing efficiency, global compliance and a more focused R&D structure in initial comments to Wall Street.
The Israel-based manufacturer saw its full-year U.S. generic revenues drop 32% due to expired marketing exclusivities and manufacturing problems at two plants. However, the fourth quarter brought a rebound, thanks to launches of generic Zyprexa and Combivir and a profit-sharing agreement on atorvastatin.