The USFDA conducted an inspection of the facility from 30 March to 3 April 2026 and issued four Form 483 observations. The receipt of the EIR with a VAI classification indicates the successful closure of the inspection.

The company said the facility remains an important part of its global manufacturing and supply network, with continued focus on quality systems, regulatory compliance, and patient safety.

Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). The company’s consolidated net profit climbed 32.58% to Rs 201.56 crore on 22.81% increase in revenue from operations to Rs 1,470.60 crore in Q4 FY26 over Q4 FY25.