Key Development
Zydus Lifesciences Limited has received the Establishment Inspection Report (EIR) from the USFDA for its injectable manufacturing facility located at Zydus Biotech Park, Ahmedabad. The report assigns a Voluntary Action Indicated (VAI) classification to the facility.
Inspection Details
The Good Manufacturing Practice (GMP) surveillance inspection was conducted by USFDA officials from April 27, 2026, to May 5, 2026 (7 working days).
Facility Information
The inspection covered the company's injectable manufacturing facility situated at Zydus Biotech Park, Ahmedabad, India.
Regulatory Classification
The VAI (Voluntary Action Indicated) classification indicates that objectionable conditions were found during the inspection, but the FDA is not recommending or requiring official action at this time. The company is expected to take voluntary corrective measures.
Disclosure Compliance
The company has made this disclosure in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, requiring prompt disclosure of material events.
Communication Details
The disclosure was formally communicated to both BSE Limited and National Stock Exchange of India Limited on August 1, 2026, by Dhaval N. Soni, Company Secretary and Compliance Officer of Zydus Lifesciences Limited.