News | December 15, 2025
Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The company will respond to the US FDA within the stipulated timelines
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Valorum will advance the commercialization and distribution of Armlupeg in the United States
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
The agreement allows Biocon Biologics to commercialize both its Denosumab biosimilars (Vevzuo and Evfraxy) in Europe starting December 2, 2025
The deal aims to address long-standing imbalances in pharmaceutical trade while boosting investment and innovation on both sides of the Atlantic
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