Granules India Limited has informed the Exchange regarding a press release dated March 31, 2026, titled "Granules Life Sciences Receives VAI Classification following US FDA Inspection".
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Granules India's wholly-owned subsidiary Granules Life Sciences Private Limited (GLS) has received a Voluntary Action Indicated (VAI) classification from the US FDA following an inspection of its oral solid dosage manufacturing facility at Shamirpet, Telangana. The inspection, conducted between December 15-19, 2025, covered current Good Manufacturing Practice (cGMP) and pre-approval inspection (PAI) requirements. The Establishment Inspection Report (EIR) has been issued and the inspection is now closed with no regulatory action recommended. This outcome strengthens the company's finished dosage manufacturing capabilities by enabling multi-site manufacturing for approved products. The company's CMD Dr. Krishna Prasad Chigurupati noted this is a step in the right direction while emphasizing continued commitment to quality.
This is a positive development for shareholders as it clears regulatory uncertainty at the Shamirpet facility and supports new product approvals through successful pre-approval inspection. The clean closure without regulatory action enables expanded multi-site manufacturing capacity, which can support future revenue growth from the US market.