FDA flags five procedural observations, no data integrity or product safety issues.
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 primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
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The companys consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25.
Shares of Granules India rose 0.50% to settle at Rs 583.30 on Friday, 19 December 2025.
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