Granules India Unit Faces 5 USFDA Observations at Hyderabad Facility

• Granules Life Sciences Private Ltd, a Granules India subsidiary, completed a USFDA inspection at its Hyderabad facility.
• The inspection, conducted from December 15-19, 2025, concluded with five observations.
• Observations relate to procedural requirements, with no issues concerning data integrity or product safety.
• Granules India commits to promptly addressing the observations and submitting a response to the USFDA.
• The company reported strong Q2 FY25 results: net profit up 35% to ₹131 crore and revenue up 34.2% to ₹1,297 crore.

Why It Matters: Granules India's Hyderabad unit received 5 USFDA observations, but assures no data integrity issues.