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Zydus receives USFDA EIR for Ankleshwar API facility with ‘No Action Indicated' status

Zydus receives USFDA EIR for Ankleshwar API facility with ‘No Action Indicated' status

Business Upturn11-06-2025
By News Desk Published on June 11, 2025, 18:24 IST
Zydus Lifesciences Limited announced on Wednesday that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API manufacturing facility located in Ankleshwar, Gujarat.
The inspection, which was carried out between March 10 and March 14, 2025, has been classified as 'No Action Indicated' (NAI), indicating that the USFDA found no objectionable conditions during its assessment. The inspection is now officially closed, the company confirmed in a press release dated June 11, 2025.
This development is seen as a positive regulatory milestone for Zydus, ensuring continued compliance and uninterrupted operations at its active pharmaceutical ingredient (API) facility.
The company has disclosed the update under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and has submitted the information to both BSE (Code: 532321) and NSE (Symbol: Zyduslife).
Shares of Zydus Lifesciences may react to this regulatory update when markets open.
News desk at BusinessUpturn.com
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