Zydus Lifesciences Ltd has received a clean report from the US Food and Drug Administration (USFDA) for its manufacturing facility at SEZ-II, Ahmedabad, the company informed in a stock exchange filing on Wednesday, November 5.

The inspection — a Pre-Approval Inspection (PAI) — was conducted between 11 and 14 August 2025, and concluded with no observations.

The USFDA has issued an Establishment Inspection Report (EIR) classifying the facility as “No Action Indicated” (NAI), effectively closing the inspection.

Zydus said the outcome reaffirms its compliance standards and strengthens the company’s regulatory record, paving the way for future product approvals from the site. The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regul

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