The US Food and Drug Administration (USFDA) has concluded its inspection of the manufacturing facility of Granules Life Sciences a wholly owned subsidiary of Granules India, at Shameerpet, with a classification of Voluntary Action Indicated (VAI).
The Establishment Inspection Report (EIR) was issued following 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 is now closed, and no regulatory action has been recommended, the company said in a release on Monday.
“While receiving the classification is a step in the right direction, we recognise 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,’’ Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India said.
The development further strengthens Granules India’s finished dosage manufacturing capabilities by enabling multi‑site manufacturing for the approved products, he added.