Zydus Cadila Strides Ahead With NASH Filing In India
API Manufacturing Unit In Dabhasa Receives NAI
Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.
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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.”