Zydus Lifesciences Limited has received the Establishment Inspection Report (EIR) from the USFDA for its injectable facility at Zydus Biotech Park, Ahmedabad. The facility has been classified as Voluntary Action Indicated (VAI). This positive regulatory outcome follows a GMP surveillance inspection conducted between April 27th and May 5th, 2026, and is a significant step for the company’s injectable manufacturing capabilities.
USFDA Classification for Injectable Facility
Zydus Lifesciences Limited announced today that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its injectable facility. The facility, located at Zydus Biotech Park in Ahmedabad, has been assigned a Voluntary Action Indicated (VAI) classification by the USFDA.
Inspection Details and Outcome
The VAI classification signifies a favourable regulatory outcome following a routine Good Manufacturing Practices (GMP) surveillance inspection. This inspection was conducted by the USFDA from April 27th, 2026, to May 5th, 2026. The VAI status indicates that while observations were made, they do not currently warrant a more severe regulatory action like an Official Action Indicated (OAI) classification, positioning the facility positively for future operations and product approvals.
Source: BSE
