Zydus Gets USFDA Nod For Dabhasa API Facility
13 Jun 2025 CW Team
Zydus Lifesciences has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Dabhasa, near Vadodara.
The USFDA conducted a routine inspection of the facility from 21st to 25th April 2025. Following the assessment, the agency has classified the outcome as "Voluntary Action Indicated" (VAI), indicating that while some observations were made, no further regulatory action is currently required. The inspection is now officially closed.
This regulatory update was disclosed in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company has requested that the exchange and its investors take note of this development.
The successful closure of the inspection underscores Zydus’s ongoing commitment to maintaining high standards of quality and regulatory compliance at its manufacturing facilities.