Zydus gets USFDA EIR for Ahmedabad oncology injectable facility

Zydus Lifesciences has announced that it has received the Establishment Inspection Report (EIR) and an approval letter from the USFDA. This clearance follows a Pre-Approval Inspection (PAI) conducted at the company's SEZ oncology injectable manufacturing facility located in SEZ1, Ahmedabad. The approval specifically pertains to a new isolator injectable line at the site. The USFDA inspection was carried out between November 4 and November 13, 2025. This regulatory approval is crucial for the company, as it signifies that the facility meets the necessary standards for manufacturing oncology injectable products, potentially paving the way for future product approvals and commercialization from this specialized line.