Zydus Lifesciences announced on Sunday (September 21) that it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its oncology injectable manufacturing unit located at SEZ1, Ahmedabad.
The inspection, conducted between June 9 and June 18, 2025, was a GMP follow-up. The USFDA has classified the facility as Voluntary Action Indicated (VAI), an improvement from the earlier Official Action Indicated (OAI) status assigned in June 2024. The revision is seen as a positive development for Zydus, indicating progress in regulatory compliance.
Recent Launches by Subsidiary ZyVet
Just last week, Zydus’ animal health subsidiary, ZyVet, launched FDA-approved generics for urinary incontinence (phenylpropanolamine hydrochloride) and heart failure management (furosemide) in pets. These launches strengthen the company’s growing presence in the veterinary healthcare segment.
Ongoing USFDA Engagements
Earlier this month, Zydus reported the completion of another USFDA inspection at its injectable manufacturing facility in Jarod, near Vadodara. The audit, carried out from August 25 to September 5, 2025, resulted in four observations, none related to data integrity. The company said it is addressing the findings promptly.
