Granules India receives one observation from USFDA following inspection at U.S. facility

Granules India announced that its wholly-owned foreign subsidiary, located in Chantilly, Virginia, USA, has received one observation in Form 483 from the United States Food and Drug Administration (USFDA).

In a regulatory filing, the company stated that the USFDA conducted a Pre-Approval Inspection (PAI) at the facility from 23 June to 27 June 2025. At the conclusion of the inspection, the USFDA issued a Form 483 with one observation.

Granules Pharmaceuticals, Inc. addressed and resolved the observation during the inspection.

The official announcement was made on 27 June 2025, after market hours.

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 rose by 17.3% to Rs 152.03 crore, on a 2.4% increase in total revenue from operations to Rs 1,196.82 crore in Q4 FY25, compared to Q4 FY24.

The scrip rose 0.03% to settle at Rs 497.30 on Friday, 27 June 2025.

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