The inspection, which covered current Good Manufacturing Practice (cGMP) and pre-approval requirements for oral solid dosage operations, was conducted between December 15 and 19, 2025, the company said in a press release filed with the exchanges on Tuesday, March 31.
The company added that the Establishment Inspection Report (EIR) has been issued and the inspection is now closed, with no regulatory action recommended by the USFDA.
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Granules said the outcome strengthens its finished dosage manufacturing capabilities by enabling multi-site production for approved products.
Commenting on the development, Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, said, “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.”
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The facility inspected is located in Shamirpet, Telangana, and forms part of the company’s broader manufacturing network supporting global pharmaceutical markets.
Shares of Granules India closed 0.63% lower at ₹620.40 on Monday, ahead of the announcement. The stock has delivered a return of 20% over the last six months.
