ALFA Filings
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5 announcements with these filters
Zydus Lifesciences received final USFDA approval for Indocyanine Green for Injection with 180-day exclusivity. The reference brand had annual U.S. sales of approximately USD 125.8 million.
Zydus Lifesciences received US FDA Priority Review for its saroglitazar NDA. The PDUFA target action date is set for November 27, 2026, boosting product pipeline visibility.
Zydus Lifesciences received DCGI approval to initiate Phase III clinical trials for Zintrodiazine, a novel anti-malarial candidate. Two trials involving 651 and 390 patients will evaluate efficacy against P. falciparum and P. vivax malaria in India. This marks a significant milestone in developing alternatives to current artemisinin-based therapies facing resistance.
Zydus Lifesciences Limited received the Establishment Inspection Report (EIR) and approval from the USFDA for its oncology injectable facility in SEZ1, Ahmedabad. The approval follows a Pre-Approval Inspection conducted in November 2025 for a new isolator injectable line. This regulatory milestone clears the path for commercial manufacturing at the site.
Zydus Lifesciences received final USFDA approval for Dapagliflozin Tablets (5 mg and 10 mg), used for type 2 diabetes. The drug had annual US sales of approximately ₹94,860 Crore. Zydus is eligible for 180 days of shared generic exclusivity, with manufacturing based in Ahmedabad SEZ.