Latest news with #Form-483
Business Standard
26-06-2025
- Business
- Business Standard
SMS Pharma's Hyderabad facility clears USFDA inspection with zero observations
SMS Pharmaceuticals announced that its Central Laboratory Analytical Services, located at, Gagillapur, Telangana, has successfully cleared the recent inspection by the US Food and Drug inspection (USFDA) with zero observations. The inspection was conducted from 23rd June 2025 to 25th June 2025, concluded with zero Form-483 observations. The company said that the Central Laboratory Analytical Services is its independent testing laboratory, and this was the second successful USFDA inspection for the facility. SMS Pharmaceuticals is a diversified and integrated pharmaceutical company specializing in APIs and intermediates for global customers. The company operates two state-of-the-art manufacturing facilities in Hyderabad and Vizag. The companys consolidated net profit jumped 17.6% to Rs 20.32 crore on 1% increase in net sales to Rs 248.20 crore in Q4 FY25 over Q4 FY24. The counter added 2.31% to end at Rs 239.05 on the BSE.
The Hindu
19-06-2025
- 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
19-06-2025
- 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
16-06-2025
- 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
16-06-2025
- 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.
