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
This marks the first partnership between Pfizer and Cipla in India
This agreement will enhance Lupin’s gastroenterology portfolio and expand its presence in emerging markets
India plays a critical role in Bristol Myers Squibb’s global strategy
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD
The inspection concluded with one minor observation in Form 483
These building blocks are essential to modern therapeutics, including fast-growing GLP-1 treatments for weight loss and diabetes
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
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