Zydus Receives EIR for SEZ II Facility in Ahmedabad from USFDA

Filed: November 5, 2025

Filing Summary

On November 5, 2025, Zydus Lifesciences Ltd announced the receipt of an Establishment Inspection Report (EIR) from the USFDA for its SEZ II manufacturing facility in Ahmedabad. The inspection, conducted from August 11 to 14, 2025, concluded with no observations, classifying the facility as No Action Indicated (NAI). his indicates that the facility met all necessary compliance requirements during the inspection period.

On November 5, 2025, Zydus Lifesciences Ltd reported that its SEZ II manufacturing facility in Ahmedabad received an Establishment Inspection Report (EIR) from the USFDA. The inspection was conducted from August 11 to 14, 2025, as a Pre-Approval Inspection (PAI).

The USFDA concluded the inspection with no observations, classifying the facility as No Action Indicated (NAI). This indicates that the facility met all necessary compliance requirements during the inspection period.

This information was disclosed in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company requested that this update be communicated to the members of the exchange and investors at large.

Zydus Lifesciences Ltd focuses on the development and manufacturing of pharmaceutical products. The company prioritizes compliance with international regulatory standards and aims to expand its global footprint in the pharmaceutical industry.

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