By: IPP Bureau
Last updated : September 24, 2025 9:57 am
The facility has been classified as Voluntary Action Indicated
Zydus has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its oncology injectable manufacturing facility located at SEZ1, Ahmedabad.
The EIR follows a Good Manufacturing Practices (GMP) follow-up inspection conducted by the USFDA from June 9 to June 18, 2025. The facility has been classified as Voluntary Action Indicated (VAI). This marks a significant improvement from the earlier classification of Official Action Indicated (OAI)issued in June 2024.
This development underscores Zydus’ continued commitment to maintaining the highest standards of quality and compliance in its manufacturing operations.