Granules Life Sciences Private Limited (GLS), a subsidiary of Granules India Limited, has successfully concluded a US FDA inspection at its Shamirpet facility. The inspection resulted in a Voluntary Action Indicated (VAI) classification, meaning no regulatory action has been recommended. The inspection, covering cGMP and PAI for oral solid dosage manufacturing, took place in December 2025. This outcome is crucial for strengthening the company’s multi-site manufacturing capabilities for approved products.
US FDA Inspection Concludes with VAI Classification
Granules India Limited announced on March 31, 2026, that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has completed a recent inspection by the US Food and Drug Administration (FDA). The inspection covered the manufacturing facility located in Shamirpet, Telangana.
The result of the inspection was classified as Voluntary Action Indicated (VAI). The Establishment Inspection Report (EIR) followed a current Good Manufacturing Practice (cGMP) and pre-approval inspection (PAI) conducted between December 15 and 19, 2025, focusing on oral solid dosage manufacturing operations.
Crucially, the inspection is now closed, and no regulatory action has been recommended by the FDA.
Management Commentary and Strategic Impact
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, commented on the development, emphasizing that while the VAI classification is a positive step, quality remains an ongoing commitment across all sites.
This successful closure of the inspection is noted to further strengthen Granules India’s finished dosage manufacturing capacity, specifically by enabling multi-site manufacturing for previously approved products.
About Granules India Ltd.
Granules India Limited is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company operates across the entire value chain, including Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), Finished Dosages (FDs), and Peptides CDMO. The company currently maintains 11 manufacturing facilities globally (8 in India, 2 in the USA, and 1 in Switzerland) and serves over 300+ customers in regulated and semi-regulated markets.
Source: BSE
