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.
