Granules Life Sciences Secures US FDA VAI Classification for Hyderabad Facility
The VAI classification indicates that while certain observations were made during the inspection, they do not warrant enforcement action, allowing the facility to continue operations without restrictions.
Inspection closure without regulatory action strengthens manufacturing capabilities
Hyderabad: Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Pvt Ltd, has received a Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration following an inspection of its manufacturing facility in Shamirpet, Hyderabad.
The Establishment Inspection Report (EIR) was issued after a combined current Good Manufacturing Practice (cGMP) and pre-approval inspection (PAI) conducted between December 15 and 19, 2025, covering oral solid dosage manufacturing operations. The inspection has now been formally closed, with no regulatory action recommended.
The VAI classification indicates that while certain observations were made during the inspection, they do not warrant enforcement action, allowing the facility to continue operations without restrictions.
Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said the outcome reflects progress while reinforcing the company’s ongoing focus on quality.
“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,” he said.
The development is expected to enhance Granules India’s finished dosage manufacturing capabilities by enabling multi-site production for approved products, strengthening operational flexibility and supply chain resilience.
