Zydus Ready For Moraiya Reinspection In June
Levorphanol Write-Down Dents Zydus in Q2 But Saroglitazar Expectations Build
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.
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Zydus Cadila hopes to launch its version of Gilead’s remdesivir by end-July in India, even as earlier licensees Hetero Drugs and Cipla have just commercialized the antiviral. Plans for pegylated interferon alfa-2b to treat COVID-19 include a trial in Mexico and an IND in the US. Separately, desidustat is being considered for additional indications.
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.
India’s Cadila Healthcare, which has been suffering on the earnings front, is amalgamating four subsidiaries under its roof to reduce overheads from managing separate entities and avoid duplication of efforts after posting weak second-quarter earnings.