Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located at Dabhasa, near Vadodara, Gujarat.
The inspection was conducted by the USFDA from April 21 to April 25, 2025. Following the inspection, the facility has been classified as "Voluntary Action Indicated" (VAI), and the agency has confirmed the inspection as "closed," signaling that the company has addressed or is expected to address the issues raised without further regulatory action.
Zydus, in a regulatory filing, stated that this update is being disclosed in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company requested the stock exchanges to bring the information to the attention of investors and stakeholders.
The VAI classification indicates that although some objectionable conditions were found during the inspection, they do not meet the threshold for regulatory sanctions and do not significantly impact the quality of the products manufactured at the site.
This development marks a positive step for Zydus as it continues to maintain compliance across its manufacturing operations and expand its global supply capabilities.
