USFDA11 Nov 2025, 11:24 am
Granules India's Hyderabad Facility Receives First U.S. FDA Approval
AI Summary
Granules India Limited announced that its subsidiary, Granules Life Sciences Private Limited (GLS), located in Hyderabad, has received U.S. Food and Drug Administration (FDA) approval for a product. This is the first FDA approval for the GLS site and marks a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. The approval will help strengthen market share and support business continuity through multi-site manufacturing.
Key Highlights
- Granules India's Hyderabad facility receives first U.S. FDA approval
- Approval for a product that was the subject of a Pre-Approval Inspection (PAI)
- GLS facility is now deemed approved by the U.S. FDA
- New approval will help strengthen market share and support business continuity
- Granules India plans to launch the approved product in the U.S. market soon