Hyderabad, Mar 31 (TNT): Granules India Limited on Tuesday said its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has received a Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (US FDA) following an inspection of its 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 from December 15 to 19, 2025. The inspection has been closed, with no regulatory action recommended.
Krishna Prasad Chigurupati, Chairman and Managing Director, said the classification reflects progress while reinforcing the company’s focus on quality as a continuous priority across its operations.
The Hyderabad-based company said the outcome will strengthen its finished dosage manufacturing capabilities by enabling multi-site production for approved products.
TNT KS
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