Latest news with #Form-483
The Hindu
a day ago
- Business
- The Hindu
U.S. FDA issues 7 observations to Natco Pharma's formulations unit in Hyderabad
The U.S. Food and Drug Administration (U.S. FDA) has issued seven observations to Natco Pharma's formulations facility in Kothur, Hyderabad. The facility was inspected by the U.S. FDA from June 9-19. On conclusion, the company received seven observations in Form-483, Natco Pharma said on Thursday. The company said it is confident of addressing the observations within the stipulated timeline. 'The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally,' Natco Pharma said. The U.S. FDA had in April 2024 issued a warning letter to the facility while raising quality concerns. The action followed an inspection and issue of eight observations in October 2023 by the regulator. The company then said the move may result in delay or withholding of pending product approvals from the site. The facility is for oral solid dosages, including cytotoxic orals; cytotoxic injectables; and pre filled syringes. The focus product categories are oncology, gastroenterology, central nervous system and cardiology. EOM
Time of India
a day ago
- Business
- Time of India
USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad division
Natco Pharma on Thursday said the US health regulator has issued a Form 483 with seven observations after inspecting its pharma division in Hyderabad. The US Food and Drug Administration (USFDA) had conducted an inspection at the company's pharma division located in Kothur, Hyderabad, from June 9-19, 2025, Natco Pharma said in a regulatory filing. "On conclusion of the inspection, the company received seven observations in the Form-483," it said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Natco said it is confident that it will address the observations within the stipulated timeline and remains committed to being cGMP compliant and supplying high-quality products to its customers and patients globally.
New Indian Express
5 days ago
- Business
- New Indian Express
FDA observations, leadership change keep Sun Pharma stock in spotlight on Monday
CHENNAI: Shares of Sun Pharmaceutical Industries Ltd. are under investor scrutiny today following two significant developments announced over the weekend — the US drug regulator's audit findings at a key manufacturing facility and a major leadership transition. The US Food and Drug Administration (USFDA) issued a Form-483 with eight observations concerning manufacturing practices at Sun Pharma's Halol facility in Gujarat. While the observations do not constitute regulatory action, they point to areas requiring corrective measures to meet FDA compliance standards. Sun Pharma has acknowledged the observations and committed to addressing them promptly. The inspection, conducted between June 2 and June 13, 2025, is especially significant as the Halol plant has been under an import alert since December 2022 due to previous regulatory violations. In a parallel development, the company announced the elevation of Kirti Ganorkar to the role of Managing Director, effective September 1, 2025. Ganorkar, who has headed Sun Pharma's India business since 2019, will take over full operational responsibilities, with all functions reporting directly to him. Founder Dilip Shanghvi will continue as Executive Chairman of the Board, ensuring strategic continuity. In light of these developments, investors are expected to closely monitor the company's stock performance in the coming days. Market analysts say the resolution of USFDA concerns at Halol and the smooth execution of the leadership transition will be key to shaping investor sentiment and the company's near-term outlook.
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Business Standard
5 days ago
- Business
- Business Standard
Why did Natco Pharma's share price slip 3% in trade today? Details here
Natco Pharma share price: Pharmaceutical major Natco Pharma shares were under pressure on Monday, June 16, 2025, with the stock dropping up to 2.66 per cent to hit an intraday low of ₹888.20 per share. Around 10:20 AM, Natco Pharma shares continued to trade lower, down 1.64 per cent at ₹897.60 per share. In comparison, BSE Sensex was trading 0.28 per cent higher at 81,348.53 levels. Why did Natco Pharma share price slip in trade? Natco Pharma shares slipped in trade after the company said that the United States Food and Drug Administration (USFDA) has issued one (1) observation in the Form-483 for its API manufacturing plant in Mekaguda, Hyderabad. However, Natco Pharma believes that the observation is procedural in nature Natco Pharma further said that it is confident to address this observation comprehensively. The US drug authority had conducted the inspection from June 9 to June 13, 2025. Catch Stock Market Updates Today LIVE Natco Pharma results Natco Pharma's consolidated profit after tax (PAT) rose to ₹406 crore in the March quarter of FY25, from ₹386.3 crore in the March quarter of FY24. The company's revenue from operations, or topline, surged to ₹1,287.3 crore in Q4FY25, from ₹1,110.3 crore in Q4FY24. At the operating level, earnings before interest, tax, depreciation and amortisation (Ebitda) soared to ₹614.4 crore in the March quarter of FY25, from ₹539.3 crore in the March quarter of FY24. However, Ebitda margin squeezed to 47.7 per cent in Q4FY25, from 48.6 per cent a year ago. About Natco Pharma Natco Pharma, based in Hyderabad, India, is a research-driven company engaged in the development, manufacturing, and distribution of generic and branded pharmaceuticals, specialty drugs, active pharmaceutical ingredients (APIs), and crop protection products. A leading player in oncology and targeted therapies in the domestic market, Natco Pharma focuses on niche, limited-competition molecules in the US. Its manufacturing facilities are approved by major regulatory bodies including the US FDA, ANVISA (Brazil), Health Canada, and the WHO, serving over 50 international markets.
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Business Standard
5 days ago
- Business
- Business Standard
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
