Granules’ arm gets five observations from USFDA for Hyderabad facility

20 Dec 2025 Evaluate

Granules India’s wholly owned subsidiary -- Granules Life Sciences (GLS), located in Hyderabad, has completed a Good Manufacturing Practices (GMP) and Prior Approval Inspection by the U.S. Food and Drug Administration (USFDA).

The inspection, conducted from December 15 to December 19, 2025, has been concluded with five observations related to procedural requirements. None of these observations are associated with data integrity or product safety. Granules Life Sciences is engaged in the manufacturing of PFI & Finished Dosages.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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