Latest news with #Halol
Time of India
07-07-2025
- Business
- Time of India
Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA action
Drug major Sun Pharmaceutical Industries aims to bolster compliance across its manufacturing operations and work towards achieving full regulatory resolution at the three facilities facing USFDA action, according to Chairman and MD Dilip Shanghvi. In his address to shareholders in its annual report for 2024-25, Shanghvi said the company is facing US Food and Drug Administration (USFDA) compliance-related issues at three of its facilities. The company is facing an import alert for the Halol facility and also is in receipt of non-compliance letter for the Mohali facility , he stated. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Shape your journey in the unforgiving desert world of Arrakis! Shop Now Undo Additionally, the company's Dadra facility was accorded an Official Action Indicated (OAI) status in FY24, he noted. "We have completed the implementation of Corrective and Preventive Action (CAPA) in the Halol facility, which is currently awaiting USFDA inspection, and we are in the process of implementing CAPA at the Mohali and Dadra facilities," he added. Live Events Besides these three, all facilities remain compliant with global regulatory standards, including those of the US FDA, Shanghvi said. On the business front, he noted the company expects its R&D investment to be in the range of 6-8 per cent of sales in the current financial year, with enhanced focus on speciality products. The company aims to expand its product pipeline of global speciality products, he added. "Our R&D spend in FY26 is likely to be in the range of 6-8 per cent of sales, with increased spending expected on speciality products," Shanghvi stated. The Mumbai-based drug major invested USD 154 million on speciality products R&D in FY25. Sun Pharma reported consolidated revenues of Rs 52,041 crore in FY25, with the share of global speciality business increasing from 18 per cent in FY24 to 20 per cent in FY25 sales. The company sells speciality products like Ilumya, Winlevi, Cequa and Odomzo across markets. "We anticipate mid to high single-digit consolidated topline growth in FY26, and expect our global speciality business to continue on its growth path," Shanghvi said. Elaborating on the focus areas, he said the company plans to prepare the business for potential disruptions arising from tariffs and geopolitical issues. The company would also continue to focus on cost and operational efficiency, he added.
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
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
Business Standard
16-06-2025
- Business
- Business Standard
Stock Alert: NTPC, Arkade Developers, ITC, Spicejet, Sun Pharma, Syngene Intl
Securities in F&O Ban: Aditya Birla Fashion & Retail (ABFRL), Birla Soft, Central Depository Services (CDSL), Chambal Fertilisers & Chemicals, HUDCO, Indian Energy Exchange (IEX), Indian Renewable Energy Development Agency (IREDA), Manapurram Finance, RBL Bank and Titagrah Rail Systems shares are banned from F&O trading on 16 June 2025. Stocks to Watch: NTPCs board has scheduled a meeting on 17 June 2025 to raise Rs 4,000 crore through debt securities on a private placement basis. The company plans to issue unsecured non-convertible debentures (NCDs) amounting to Rs 4,000 crore through private placement at a coupon of 6.89% p.a. Arkade Developers has acquired a 6.28 acre freehold land parcel for a total consideration of Rs 172.48 crore including stamp duty, marking its foray into the Thane real estate market. The projected gross development value (GDV) is Rs 2,000 crore having a RERA saleable area of 9.26 lakh sq. ft., the project launch is slated for early 2026. NATCO Pharma said that the U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from 09 to 13 of June 2025. Syngene International said that the United States Food and Drug Administration (US FDA) conducted a good clinical practices (GCP) compliance inspection of the companys facility located at Semicon Park, Bengaluru, from 09 to 13 of June 2025. Adani Enterprises has announced that its wholly owned subsidiary, Agneya Systems (ANIL), has incorporated a new wholly owned subsidiary named Astraan Defence. The newly incorporated subsidiary operates in the defence sector and will be engaged in the manufacturing of primers, propellants, ignitors, explosives, and ammunition of various types and calibers. Lemon Tree Hotels has announced the signing of a new property in Itanagar, Arunachal Pradesh. The property will be managed by Carnation Hotels, a wholly owned subsidiary of Lemon Tree Hotels. Sun Pharmaceutical Industries announced the appointment of Kirti Ganorkar as the managing director to succeed Dilip Sanghvi, with effect from 1 September 2025. Meanwhile, USFDA conducted a good manufacturing practices (GMP) inspection at companys Halol facility (Gujarat, India) from 02 June to 13 June 2025. At the conclusion of the inspection, the USFDA issued a Form-483, with 8 observations. ITC has acquired 100% stake in Sresta Natural Bioproducts (SNBPL) for total consideration of Rs 400 crore. In addition, consideration of up to Rs 72.50 crore is payable in the next 24 months. Spicejets consolidated net profit surged 168.92% to Rs 341.88 crore on 16.08% jump in revenue from operations to Rs 1,395.96 crore in Q4 FY25 over Q4 FY24
India Today
16-06-2025
- Business
- India Today
Stocks to watch on June 16: Adani Enterprises, Sun Pharma, NTPC, Bajaj Finance
Stock markets are expected to start the new week on a cautious note on June 16, as global investors closely track ongoing geopolitical tensions in the Middle the previous week, the stock market fell by over 1% due to nervousness around rising crude oil prices and global trading resumes on Monday, shares of several companies will be in focus due to fresh developments. These include Adani Enterprises, Sun Pharma, NTPC, Bajaj Finance, Vedanta, and ENTERPRISESAdani Enterprises will be one of the top stocks to watch after the company clarified reports regarding damage to its Haifa Port in Israel. The clarification came after news reports claimed the port was hit by an Iranian Sunday, Jugeshinder Robbie Singh, the Chief Financial Officer of the Adani Group, said these reports are false. He stated that the Haifa Port has not suffered any damage and that the port is operating as statement comes at a time when investors are reacting sharply to global events, especially those linked to the Middle East PHARMASun Pharmaceutical confirmed that the US Food and Drug Administration (FDA) completed an inspection of its Halol plant. The inspection ended with eight observations issued in a Form 483 inspections are important for pharmaceutical companies as they decide whether the company can continue to supply medicines to the US, one of its biggest markets. Investors will be watching to see how the company responds to these FINANCEBajaj Finance shares will be in the spotlight as they will trade ex-bonus and ex-stock split starting June 17. The company had announced a bonus issue in the ratio of 4:1, meaning shareholders will receive four additional shares for each share with this, the face value of each share will be split from Rs 2 to Rs 1, making the shares more affordable for retail investors. These changes were part of the company's announcements during its fourth-quarter earnings the state-run power producer, announced that it has started commercial operations at Unit-3 of the North Karanpura Super Thermal Power Project. This unit has a capacity of 660 start of commercial operations means the company can now earn revenue from power generated by this unit, which could help boost its financial performance in the coming announced the completion of its acquisition of 100% stake in Sresta Natural Bioproducts (SNBPL) for Rs 400 crore. As a result, SNBPL and its overseas companies in the US and UAE have now become wholly owned subsidiaries of has said it will hold a board meeting on June 18 to consider an interim dividend for the current financial year, FY26. The company has fixed June 24 as the record date to determine which shareholders are eligible to receive the are payouts made to shareholders, and news of such proposals can influence stock prices ahead of the board TECHNOLOGIESGaming and media firm Nazara Technologies will also be under focus after well-known investor Rekha Jhunjhunwala sold over 27 lakh shares in the company on June move reduced her holding in the firm. Large stake sales by key investors usually draw attention in the stock market, and share prices may react INTERNATIONALBiotech firm Syngene International has received an Establishment Inspection Report (EIR) from the US FDA for its GMP manufacturing units located in Biocon Park. This report suggests that the FDA has completed its inspection and has no immediate regulatory is seen as a positive sign for the company and may lead to investor interest in the stock. advertisement
