Compliance review: Sun Pharma's Halol plant gets 8 USFDA observations; company vows remedial steps after inspection
Sun Pharmaceutical Industries Ltd on Saturday said the US Food and Drug Administration (USFDA) has issued a Form 483 with eight observations following an inspection of its Halol manufacturing facility in Gujarat.
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The inspection, which focused on Good Manufacturing Practices (GMP), was conducted between June 2 and June 13, 2025, the company said in a regulatory filing to the stock exchanges.
'At the conclusion of the inspection, the USFDA issued a Form-483 with 8 observations,' Sun Pharma stated as quoted PTI.
A Form 483 is issued by the US health regulator to a company's management when an investigator observes conditions that may violate the Food Drug and Cosmetic (FD&C) Act and associated regulations.
Such observations are not final determinations, but they typically require prompt corrective action and a written response from the manufacturer.
Sun Pharma did not disclose the nature of the observations but is expected to submit a comprehensive remediation plan in line with regulatory protocol.
Meanwhile, the drug major reported a 19% year-on-year (YoY) decline in consolidated net profit for the March quarter FY 2024-25, which stood at Rs 2,154 crore compared to Rs 2,659 crore in the same period last year.
Revenue from operations, however, rose 8% YoY to Rs 12,959 crore, up from Rs 11,983 crore in Q4FY24.
On a sequential basis, both profit and revenue decreased. Profit after tax (PAT) dropped 26% from Rs 2,913 crore in Q3FY25, while revenue fell 5% from Rs 13,675 crore in the previous quarter.
For the full financial year, net profit increased to Rs 10,965 crore from Rs 9,610 crore in FY24. Meanwhile, revenue grew by 8.5% to Rs 52,578 crore in FY25, up from Rs 48,497 crore the previous year.
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