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Zydus Cadila

www.zyduscadila.com

Latest From Zydus Cadila

CymaBay Shelves NASH Drug Seladelpar On Liver Safety Concerns

Atypical histological findings from a Phase IIb NASH study lead CymaBay to terminate mid-stage studies in NASH and PSC and place a Phase III PBC trial on hold.

Clinical Trials Drug Safety

Zydus Ready For Moraiya Reinspection In June

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.

Sales & Earnings Strategy

FDA Holds Zydus Cadila Responsible For ‘Repeat Violations’

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.”

Manufacturing Compliance

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.

Manufacturing Quality
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