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 move strengthens GBL’s clinical-stage presence in the United States
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
The product will be marketed by Dr. Reddy's Laboratories Inc.
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
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Biocon will acquire all of Viatris’ convertible preferred equity in Biocon Biologics for $400 million in cash and $415 million in newly issued Biocon shares
Biocon will acquire the residual stake held by Mylan (Viatris) for a total consideration of US$ 815 million
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