Sun Pharma’s Halol Plant: USFDA Observations and Financial Insights
USFDA Inspection and Company Response
Sun Pharmaceutical Industries Ltd recently announced that the US Food and Drug Administration (USFDA) issued a Form 483 with eight observations after inspecting its Halol manufacturing facility in Gujarat.
Inspection Details
- The inspection happened from June 2 to June 13, 2025.
- It focused on Good Manufacturing Practices (GMP).
The USFDA issues a Form 483 when investigators find conditions that may violate the Food Drug and Cosmetic (FD&C) Act and related regulations. These observations need quick fixes and a written response from the company.
Company’s Next Steps
Sun Pharma did not share the details of the observations. However, they plan to submit a detailed remediation plan as per regulatory guidelines.
Financial Performance Overview
Quarterly Results
Sun Pharma reported a 19% year-on-year decline in consolidated net profit for the March quarter of FY 2024-25. The profit was Rs 2,154 crore, down from Rs 2,659 crore in the same period last year.
Revenue from operations increased by 8% year-on-year to Rs 12,959 crore, up from Rs 11,983 crore in the previous year’s quarter.
Sequential Performance
Compared to the previous quarter, both profit and revenue decreased:
- Profit after tax dropped 26% from Rs 2,913 crore in Q3 FY25.
- Revenue fell 5% from Rs 13,675 crore in the previous quarter.
Annual Performance
For the full financial year, Sun Pharma saw an increase in net profit and revenue:
- Net profit rose to Rs 10,965 crore from Rs 9,610 crore in FY24.
- Revenue grew by 8.5% to Rs 52,578 crore in FY25, up from Rs 48,497 crore the previous year.
