Granules Life Sciences Receives VAI Classification Following US FDA Inspection
Hyderabad, March 31, 2026 — Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has received a Voluntary Action Indicated (VAI) classification following a US FDA inspection of its manufacturing facility in Shamirpet, Telangana.The Establishment Inspection Report (EIR) was issued after a current Good Manufacturing Practice (cGMP) and pre-approval inspection (PAI) of the oral solid dosage manufacturing operations, conducted between December 15 and 19, 2025. The inspection has now concluded, and no regulatory action has been recommended.
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, stated that the classification represents a step forward and underscored the company's ongoing commitment to quality.
The development is expected to strengthen Granules India's finished dosage manufacturing capabilities, enabling multi-site manufacturing for approved products.
About Granules India Ltd. (BSE: 532482, NSE: GRANULES )
Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company’s facilities support the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and Peptides CDMO. Granules distributes products to customers in regulated and semiregulated markets with a global presence extending to over 80 countries. The company operates 11 manufacturing facilities, including 8 in India, 2 in the USA, and 1 in Switzerland, and holds regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.Source:
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