Drug Approval | December 17, 2025
Lupin receives EIR from USFDA for Nagpur injectable facility
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The state-of-the-art facility is a 350-bedded, multi-specialty tertiary care hospital
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The company will respond to the US FDA within the stipulated timelines
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