Drug Approval | December 20, 2025
Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
The NP resin portfolio, indicated by its UL746G-certified prefix, equips manufacturers across industries to meet increasingly stringent regulatory and performance standards
The center will deliver Certified Pre-Owned instruments restored to factory-grade standards and backed by Agilent Standard Warranty
This agreement will enhance Lupin’s gastroenterology portfolio and expand its presence in emerging markets
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
The expansion includes a larger technical and service team and increased local procurement
The new facility is expected to generate 500-600 new jobs in the region
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