Granules Life Sciences Gets USFDA VAI Nod for Shamirpet Unit

Granules India Limited has shared that its subsidiary, Granules Life Sciences, has received a Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (USFDA) after an inspection of its Shamirpet facility in Telangana.

The inspection, carried out between December 15 and 19, 2025, was a routine check for compliance with current Good Manufacturing Practices (cGMP) as well as pre-approval requirements. With the VAI classification, the USFDA has officially closed the inspection without recommending any regulatory action.

In simple terms, a VAI status means that while the inspectors may have noted a few observations, they were not serious enough to impact the facility’s operations. The plant can continue functioning normally, which is a positive sign for the company.

Speaking about the development, Chairman and Managing Director Krishna Prasad Chigurupati said the outcome reflects the company’s ongoing efforts to maintain high quality standards. He added that Granules remains committed to continuously improving its manufacturing processes and compliance systems.

This development is expected to strengthen the company’s manufacturing capabilities, especially in producing finished dosage medicines for regulated markets like the United States. It also gives Granules more flexibility to use multiple facilities for approved products, helping improve efficiency and supply reliability.

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Granules Life Sciences plays an important role in the company’s global operations, particularly in the production of oral solid dosage forms such as tablets and capsules. A positive inspection outcome like this can help build trust among global customers and partners.

Overall, the VAI classification reinforces Granules India’s steady focus on quality, compliance, and growth. As the company continues to expand its presence in regulated markets, such regulatory milestones are likely to support its long-term business strategy.