News | December 12, 2025
Granules Life Sciences facility receives EIR from USFDA
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
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 approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Captured microbes are then neutralized on engineered microbicidal surfaces
The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation
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