
USFDA23 Sept 2026, 08:47 am
Glenmark Pharma Goa Facility Receives US FDA EIR with VAI Status
AI Summary
Glenmark Pharmaceuticals Ltd. has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for its formulations manufacturing facility in Goa, India. The facility has been classified with a Voluntary Action Indicated (VAI) status. The inspection took place from June 22, 2026, to June 30, 2026. This classification suggests that while the FDA noted some observations, they do not currently warrant mandatory regulatory action, indicating a generally satisfactory inspection outcome for the facility.
Key Highlights
- Glenmark Pharma's Goa facility received US FDA Establishment Inspection Report (EIR).
- The facility was classified with a Voluntary Action Indicated (VAI) status.
- The inspection covered the period from June 22 to June 30, 2026.
- VAI status generally indicates a satisfactory inspection outcome.
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