Zydus Cadila Gets Warning Letter
Addresses FDA Warning Over Moraiya Plant And Commits To Respond
Zydus Cadila has received a warning letter from the FDA for its Moraiya facility. The company has insisted that it will not affect the existing business in the US where it has filed over 330 ANDAs.
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Zydus says its Moraiya plant should be ready for re-inspection at the end of June 2020, following a recent FDA warning letter. Meanwhile, as returns from levorphanol fall on the back of increased competition, the firm has written down investment by $37.5m causing Q2 profits to slump 74%. Post successful Phase II trials in the US for NASH and NAFLD indications, its hopes are now pinned on saroglitazar magnesium.
The FDA has published details of a warning letter summarizing significant violations of cGMP regulations to Zydus Cadila. The agency called the company’s prior response “insufficient.”
Site switch also could trigger ANDA approvals sidelined as Moraiya plant recovers from US FDA warning letter.