Granules Life Sciences receives VAI classification following US FDA inspection 

Granules India announced that its wholly owned subsidiary, Granules Life Sciences (GLS), has concluded a recent US FDA inspection of its manufacturing facility at Shamirpet, Telangana, with an inspection classification of Voluntary Action Indicated (VAI). 

The Establishment Inspection Report (EIR) was issued following a current Good Manufacturing Practice (cGMP) and preapproval inspection (PAI) of the oral solid dosage manufacturing operations conducted between December 15 and 19, 2025. 

The inspection is now closed, and no regulatory action has been recommended.

Dr Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited, said, “While receiving the classification is a step in the right direction, we recognize that quality is not a one-time milestone but an ongoing commitment. It will continue to remain a core pillar of utmost importance across all Granules sites, guiding our actions, investments, and culture every day.” 

This development further strengthens Granules India’s finished dosage manufacturing capabilities by enabling multisite manufacturing for the approved products. 

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