USFDA21 Sept 2025, 09:00 am
Zydus Lifesciences receives EIR for Oncology Injectable Manufacturing Facility in SEZ1, Ahmedabad
AI Summary
Zydus Lifesciences Ltd. has announced that it has received the Establishment Inspection Report (EIR) from the USFDA for a GMP follow-up inspection conducted at its oncology injectable facility located at SEZ1, Ahmedabad from 9th to 18th June 2025. The facility, previously classified as Official Action Indicated (OAI) in June 2024, has now been revised to Voluntary Action Indicated (VAI). This disclosure is pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Key Highlights
- Zydus Lifesciences receives EIR for its oncology injectable manufacturing facility in SEZ1, Ahmedabad.
- The facility was previously classified as Official Action Indicated (OAI) but has now been revised to Voluntary Action Indicated (VAI).
- The EIR is a result of a GMP follow-up inspection conducted from 9th to 18th June 2025.
- This disclosure is pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.