Mumbai, Dec. 20 -- Granules India on 19 December 2025 said its wholly owned subsidiary, Granules Life Sciences, has completed a Good Manufacturing Practices and Prior Approval Inspection by the U.S. Food and Drug Administration.

The inspection was conducted at the subsidiary's Hyderabad facility between 15 December and 19 December 2025. The regulator issued five observations, all related to procedural requirements.

The company said none of the observations pertain to data integrity or product safety. Granules India added that it will respond to the observations within the stipulated timeframe.

Granules Life Sciences is engaged in the manufacturing of pharmaceutical formulation intermediates and finished dosage forms.

Granules India is...