Latest From Zydus Cadila
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.
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.
- Generic Drugs
- OTC, Consumer
- Therapeutic Areas
- Parent & Subsidiaries
- Zydus Cadila
- Senior Management
- Pankaj R Patel, Chmn. & Managing Dir.
- Contact Info
Phone: (91) 79 26868100
Zydus Tower, Satellite Cross Roads
Ahmedabad , 380015
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