Drug Approval | December 22, 2025
Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Additional investments planned to expand the site’s capacity and capabilities to support growing manufacturing programs
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
This marks the first partnership between Pfizer and Cipla in India
The NP resin portfolio, indicated by its UL746G-certified prefix, equips manufacturers across industries to meet increasingly stringent regulatory and performance standards
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
GS-098, a first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor, is designed to rapidly block the pathogenic activity of thyroid-stimulating autoantibodies
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
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