
USFDA31 March 2026 at 06:10 am
Granules India Subsidiary Receives VAI Classification from US FDA Inspection
AI Summary
Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Private Limited, has received a Voluntary Action Indicated (VAI) classification from the US FDA following a recent inspection of its manufacturing facility at Shamirpet, Telangana. The inspection, conducted between December 15 and 19, 2025, resulted in no regulatory action being recommended. This development strengthens Granules India’s finished dosage manufacturing capabilities and enables multi-site manufacturing for approved products.
Key Highlights
- Granules Life Sciences Private Limited receives VAI classification from US FDA
- US FDA inspection conducted at Shamirpet, Telangana facility
- No regulatory action recommended in the Establishment Inspection Report
- This development strengthens Granules India’s finished dosage manufacturing capabilities
- Enables multi-site manufacturing for approved products
GRANULESPharmaceuticals
GRANULES INDIA LTD.-$Price Impact