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
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
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 company will respond to the US FDA within the stipulated timelines
The new centre brings advanced corneal procedures pioneered in India
The product will be marketed by Dr. Reddy's Laboratories Inc.
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
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