Granules Life Sciences Private Limited (GLS), a wholly owned subsidiary of Granules India, received VAI classification from US FDA for its Shamirpet, Telangana facility.
The Establishment Inspection Report (EIR) followed a cGMP and pre-approval inspection (PAI) of oral solid dosage operations conducted December 15–19, 2025.
No regulatory action was recommended; the development enables multi-site manufacturing for approved products, strengthening finished dosage capabilities.