Granules India Ltd.'s wholly owned subsidiary, Granules Life Sciences Private Ltd. (GLS), has received a Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (USFDA) following an inspection of its manufacturing facility in Telangana. According to reports from CNBC TV18, the inspection covered current Good Manufacturing Practice (cGMP) and pre-approval requirements for oral solid dosage operations, conducted between December 15 and 19, 2025. The company announced this development in a press release filed with the exchanges on Tuesday, March 31.
The USFDA has issued the Establishment Inspection Report (EIR) and the inspection is now closed, with no regulatory action recommended by the USFDA. As reported by CNBC TV18, the facility inspected is located in Shamirpet, Telangana, and forms part of the company's broader manufacturing network supporting global pharmaceutical markets. The outcome strengthens the company's finished dosage manufacturing capabilities by enabling multi-site production for approved products.
Earlier in March, Granules India's US step-down subsidiary, Granules Consumer Health LLC (a wholly-owned subsidiary of Granules Pharmaceuticals, Inc.), received an Establishment Inspection Report (EIR) with No Action Indicated (NAI) status from the USFDA following an inspection at its Manassas, Virginia packaging facility conducted between December 1 and 3, 2025. This additional regulatory clearance demonstrates the company's consistent compliance across multiple manufacturing facilities.
Shares of Granules India closed ₹621.15, down ₹2.10 or 0.34% in the previous trading session, as reported by Moneycontrol. The stock has delivered a return of 25% over the last nine months and touched a 52-week high of ₹640.00 and a 52-week low of ₹412.05 on March 25, 2026 and April 7, 2025, respectively. Currently, the stock is trading 2.95% below its 52-week high and 50.75% above its 52-week low, with the company's market capitalization standing at ₹15,391.91 crore.
