Zydus Cadila’s New Injectables Plant Could Help Blunt US Drug Shortages
Site switch also could trigger ANDA approvals sidelined as Moraiya plant recovers from US FDA warning letter.
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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.”
As returns from levorphanol fall on the back of increased competition, Zydus Cadila writes 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.
Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.