By: IPP Bureau
Last updated : August 03, 2026 5:57 am
Regulatory clearance follows GMP surveillance inspection conducted between April 27 and May 5, 2026.
Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its injectable manufacturing facility located at Zydus Biotech Park, Ahmedabad.
The facility has been classified under Voluntary Action Indicated (VAI) following a Good Manufacturing Practices (GMP) surveillance inspection conducted by the USFDA between April 27 and May 5, 2026.
An EIR signifies the formal closure of an inspection by the USFDA. Under a VAI classification, the regulator has identified certain observations that do not warrant immediate regulatory or enforcement action but are expected to be addressed by the company through corrective measures.
The company disclosed the development in a regulatory filing under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The receipt of the EIR marks the conclusion of the USFDA's inspection process for the Ahmedabad injectable manufacturing facility.