The inspection was a Good Manufacturing Practices (GMP) follow-up audit conducted between June 9-18, 2025, at the company’s site located in SEZ 1 near Matoda, Ahmedabad.
In a regulatory filing, Zydus clarified that the observations received were minor and unrelated to data integrity. The company added that it would work closely with the FDA to address and respond to the observations promptly.
Also Read: Zydus Lifesciences Q3 Results: US formulation sales near $300 million, forex gains aid profit
Last week, Zydus Lifesciences said it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its active pharmaceutical ingredient (API) manufacturing facility located in Ankleshwar, Gujarat.
“We wish to inform that the company has received the Establishment Inspection Report (EIR) report from the US FDA for the inspection conducted at its API manufacturing facility located at Ankleshwar,” according to a stock exchange filing.
The inspection, which was conducted from March 10 to 14, 2025, has been classified as ‘No Action Indicated’ (NAI), meaning the FDA found no objectionable conditions or practices during its review. With this classification, the inspection is considered closed by the regulator.
Also Read: Zydus Lifesciences to invest $16 million in US-based Agenus for 5.9% stake
Shares of Zydus Lifesciences Ltd ended at ₹957.80, down by ₹1.10, or 0.11%, on the BSE.
(Edited by : Shoma Bhattacharjee)
