Zydus Lifesciences Ltd. has announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Ambernath, Maharashtra.
The inspection was conducted by the USFDA from February 10 to 14, 2025. Following the inspection, the facility received no observations, indicating full compliance with current Good Manufacturing Practices (cGMP). The USFDA has classified the outcome as No Action Indicated (NAI), which is the most favorable classification for such inspections.
In the exchange filing, the company shared, “We wish to inform that the company has received the EIR report from the USFDA for the inspection conducted at its API manufacturing facility located at Ambernath, Maharashtra. This facility underwent an inspection from 10th to 14th February 2025, and had ended with NIL observations. The EIR report has classified it as No Action Indicated (NAI).”
This successful outcome reinforces Zydus’ strong commitment to maintaining global regulatory standards and ensuring quality manufacturing practices across all its facilities.
