USFDA12 Dec 2025, 03:14 pm
Granules India Subsidiary Receives FDA Approval After Inspection
AI Summary
Granules India Ltd. announced that its wholly owned subsidiary, Granules Life Sciences Private Limited, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The inspection was conducted from July 28, 2025, to Aug 01, 2025, at the Hyderabad facility, which is engaged in the manufacturing of PFI & Finished Dosages. This approval confirms the facility's compliance with FDA quality standards and regulatory requirements.
Key Highlights
- Granules Life Sciences Private Limited received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA).
- The inspection was conducted from July 28, 2025, to Aug 01, 2025, at the Hyderabad facility.
- The facility is involved in the manufacturing of PFI & Finished Dosages.
- This approval confirms the facility's compliance with FDA quality standards and regulatory requirements.
- Granules India Ltd. communicated the update to the stock exchange members for dissemination.