Alembic Pharma's Gujarat Facility Clears USFDA Inspection with Two Observations

• Alembic Pharmaceuticals completed an unannounced cGMP inspection by the USFDA at its Karakhadi, Gujarat injectable facility (F-3) from February 9 to February 18, 2026.
• The inspection concluded with two observations, none of which were related to data integrity.
• The company reported a 4.1% decline in net profit to ₹132 crore in Q3, impacted by a one-time provision of ₹42 crore for employee benefits.
• Revenue increased by 10.8% year-on-year to ₹1,876.3 crore, driven by strong domestic and international operations.
• International generics (ex-US) showed significant growth of 36% year-on-year to ₹406 crore, with the company receiving seven ANDA approvals during the quarter.