Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has successfully concluded a US FDA inspection with a Voluntary Action Indicated (VAI) classification. This inspection was conducted at its manufacturing facility located in Shamirpet, Telangana.
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, which took place from December 15 to 19, 2025. The inspection is now closed, and no regulatory action has been recommended by the US FDA.
Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, commented on the development, stating, “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.”
This achievement further enhances Granules India’s finished dosage manufacturing capabilities, enabling multi-site manufacturing for the approved products.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).