Sun Pharma share slips 2% as USFDA flags 8 observations for Halol facility

Sun Pharma shares dropped in trade after the company announced that United States Food and Drug Administration (USFDA) has issued a Form-483, with 8 observations for its Halol facility in Gujarat.
SI Reporter New Delhi
Sun Pharma share price: India's largest drug maker Sun Pharma shares fell up to 1.99 per cent to hit an intraday low of ₹1,655.05 per share on Monday, June 16, 2025.
At 9:46 AM, Sun Pharma shares were off day's low but continued to trade 0.33 per cent lower at ₹1,683.15 per share. In comparison, BSE Sensex was trading 0.19 per cent higher at 81,275.77 levels.
Why did Sun Pharma shares drop in trade today?
Sun Pharma shares dropped in trade after the company announced that United States Food and Drug Administration (USFDA) has issued a Form-483, with 8 observations for its Halol facility in Gujarat.
USFDA had conducted a Good Manufacturing Practices (GMP) inspection at Halol facility from June 2 to June 13, 2025, the pharmaceutical company said, in a statement.
In an exchange filing, Sun Pharma said, 'We hereby inform you that the USFDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited's Halol facility (Gujarat, India) from June 2 to June 13, 2025. At the conclusion of the inspection, the US FDA issued a Form-483, with 8 observations.'
Sun Pharma results
Sun Pharma reported a 19 per cent year-on-year decline in consolidated net profit for Q4FY25, coming in at ₹2,149.8 crore. However, revenue from operations rose 8 per cent to ₹12,958.8 crore for the quarter.
Excluding exceptional items, adjusted net profit stood at ₹2,889.1 crore, marking a 4.8 per cent increase.
The company cited seasonally softer sales in the US during January and February as a partial reason for the muted quarterly performance, though it noted that prescription and inventory trends for key brands remained robust. Higher input costs also weighed on profitability.
For the full financial year FY25, net profit grew 14 per cent Y-o-Y to ₹10,929 crore, while revenue increased 8 per cent to ₹52,578 crore.
Despite the annual growth, both Q4 net profit and revenue missed Bloomberg estimates by 23 per cent and 2.23 per cent, respectively.
About Sun Pharma
Established in 1983, Sun Pharmaceutical Industries (Sun Pharma) is the world's fourth-largest specialty generic pharmaceutical company, with global revenues of $5.8 billion. With a presence in over 100 countries and 41 manufacturing facilities worldwide, Sun Pharma delivers high-quality, affordable medicines trusted by healthcare professionals and patients alike.
Its diverse portfolio includes over 2,000 high-quality molecules across generics, branded generics, specialty and complex products, OTC, ARVs, APIs, and intermediates—spanning multiple dosage forms such as tablets, capsules, injectables, inhalers, and topical formulations.
The company is ranked among the top generic pharmaceutical firms in the US, especially in the dermatology space, and maintains a strong presence across key emerging markets like Brazil, Mexico, Russia, and South Africa.
The company consistently invests 6–8 per cent of its global revenues in R&D, supported by a team of over 3,000 scientists, driving innovation in areas like liposomal formulations, lyophilised injections, and controlled-release systems

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