Zydus Lifesciences Limited has received the Establishment Inspection Report (EIR) and approval letter from the USFDA for the Pre-Approval Inspection (PAI) conducted at SEZ oncology injectable manufacturing site in SEZ1, Ahmedabad, in relation to the new isolator injectable line. The inspection was conducted from November 4, 2025 to November 13, 2025.
Zydus Lifesciences Limited is an India-based life-sciences company with positions across pharmaceuticals and consumer wellness, supported by a MedTech franchise and a global footprint across United States, India and other international markets. Its pharmaceutical business includes integrated pharmaceutical operations with business encompassing the entire value chain in research, development, production, marketing and distribution of pharmaceutical products. Its product portfolio includes active pharmaceutical ingredients, human formulations, and animal health and veterinary. Its consumer products business includes development, production, marketing and distribution of differentiated health and wellness products. It provides biologicals manufacturing sites offering contract development and manufacturing organization services to biopharmaceutical companies globally. Its focused therapy areas include cardiology, anti-diabetes, super specialty areas of oncology and nephrology, and others.
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