Zydus Lifesciences Limited announced that the U.S. Food and Drug Administration (USFDA) has successfully completed a Pre-Approval Inspection (PAI) at the company’s manufacturing plant located in SEZ–II, Ahmedabad. The inspection was conducted between August 11 and August 14, 2025, and has now been officially closed by the USFDA.
Importantly, the inspection concluded with no observations, reflecting the company’s strong commitment to maintaining the highest standards of quality and compliance. The Establishment Inspection Report (EIR) classified the facility as No Action Indicated (NAI), which is the best possible outcome following a USFDA inspection.
Zydus stated that this update is being made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
This positive outcome reinforces Zydus’ reputation for operational excellence and strengthens its position in the global pharmaceutical market, paving the way for timely product approvals from the USFDA.
