Granules India Arm Gets USFDA VAI Status for Shamirpet Facility, No Action Required

The inspection was conducted at the Shamirpet facility in Telangana between December 15 and December 19, 2025, covering current Good Manufacturing Practice (cGMP) compliance and pre-approval inspection (PAI) of oral solid dosage operations. Following this, the USFDA issued the Establishment Inspection Report (EIR), confirming closure of the inspection without recommending any regulatory action.

A VAI classification indicates that while certain observations may have been noted during the inspection, they do not warrant any enforcement action by the regulator. Commenting on the development, Chairman and Managing Director Dr. Krishna Prasad Chigurupati stated that the classification represents progress but emphasized that maintaining quality standards remains an ongoing commitment across all company sites.

The company noted that this outcome strengthens its finished dosage manufacturing capabilities, enabling multi-site manufacturing for approved products and enhancing operational flexibility.

Granules India Limited, headquartered in Hyderabad, is a vertically integrated pharmaceutical company engaged in the manufacturing of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosage forms. The company operates across more than 80 countries and serves over 300 customers globally.

With multiple regulatory approvals from global authorities including the USFDA and EU GMP, Granules India continues to focus on quality, compliance, and expansion in regulated markets.

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