FCC

Zydus Gets USFDA Clearance for Ankleshwar API Plant

2025-06-13

Zydus has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat. The facility underwent a comprehensive inspection by the USFDA from 10th to 14th March 2025.

The inspection has been classified as “No Action Indicated” (NAI), confirming that no objectionable conditions or practices were found during the review. The agency has now officially closed the inspection process.

This update has been disclosed in compliance with Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

The receipt of the EIR underscores Zydus’s ongoing commitment to maintaining global quality standards at its manufacturing sites. It also reinforces the company’s regulatory track record and strengthens its position in the US pharmaceutical market.