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Time of India
14-07-2025
- Business
- Time of India
Glenmark Pharma shares in focus after USFDA warning to Indore plant
Glenmark Pharmaceuticals shares may be in focus on Monday, July 14, after the company disclosed that it has received a warning letter from the U.S. Food and Drug Administration (FDA) for its facility in Indore, Madhya Pradesh. The inspection at Glenmark's Indore site was conducted between February 3 and February 14, 2025. Following the inspection, the FDA issued a warning letter highlighting concerns related to quality and compliance. 'We wish to inform you that the company has received a warning letter from the U.S. FDA for the company's Indore, Madhya Pradesh (India) facility. The U.S. FDA had inspected Glenmark's Indore site from February 3, 2025 to February 14, 2025,' the company said in an exchange filing. However, Glenmark clarified that the warning letter is not expected to impact existing supplies or revenue from operations at the Indore site. The company stated, 'The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.' Addressing investor concerns, Glenmark emphasized its commitment to resolving the issues raised by the U.S. FDA at the earliest. It also clarified that there were no observations related to data integrity during the inspection. 'We uphold quality and compliance issues with utmost importance and remain committed to being compliant with CGMP quality standards across all our facilities,' the company noted. This update follows Glenmark's earlier intimation on May 9, 2025, regarding the Indore facility receiving Official Action Indicated (OAI) status from the U.S. FDA. On Friday, shares of Glenmark Pharmaceuticals surged 14.5% to close at Rs 2,181.55 on BSE. Also read: Madhuri Kela-backed smallcap stock zooms nearly 100% in 3 months, hits new all-time high ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
Business Upturn
14-07-2025
- Business
- Business Upturn
Stock in focus today: Glenmark Pharmaceuticals shares eyed after US FDA warning letter to Indore facility
Glenmark Pharmaceuticals will be in focus on Monday, July 14, after the company disclosed that it has received a warning letter from the United States Food and Drug Administration (US FDA) for its Indore manufacturing facility in Madhya Pradesh. The regulatory action follows an inspection conducted by the US FDA between February 3 and February 14, 2025. In a statement, Glenmark clarified that the warning letter is not expected to impact current supplies or revenues generated from the Indore site. Importantly, the company confirmed that the US FDA's observations did not involve any data integrity issues. 'This warning letter will not affect the availability of our products in the market, and we remain focused on ensuring consistent supply without disruptions,' the company said. Glenmark also reaffirmed its commitment to addressing the concerns raised by the regulator, noting it is working closely with the US FDA to resolve the issues at the earliest possible. The company emphasized its adherence to Current Good Manufacturing Practices (CGMP) and its focus on maintaining high quality and compliance standards across all operations. This development comes after Glenmark had earlier informed on May 9, 2025, that the Indore facility was classified as 'Official Action Indicated' (OAI) by the US FDA. Investors and analysts will closely watch how the stock reacts today as the company works through the regulatory process and reassures the market about its supply chain and compliance measures. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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.
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Business Standard
29-06-2025
- Business
- Business Standard
Indian pharma eyes US gains as $63.7 bn patent cliff nears: Analysts
The Indian pharmaceutical industry is poised to benefit from a major wave of patent expiries in the US, with small-molecule drugs worth $63.7 billion expected to go off-patent between 2025 and 2029—a 65 per cent increase over the previous five years. Combined with a broader Loss of Exclusivity (LoE) opportunity across the US and EU projected to reach $180 billion by 2035, this marks a significant opening for Indian drugmakers, according to a report by Antique Stock Broking Limited. This shift is expected to spur a rise in generic launches, particularly benefiting Indian players with emerging US operations and expertise in complex generics. Firms such as Alembic Pharmaceuticals and Shilpa Medicare, which have smaller US footprints, and larger players like Cipla and Lupin, which have invested early in differentiated products such as injectables and respiratory therapies, are seen as well positioned to gain market share. With global majors like Teva, Viatris and Sandoz having closed dozens of manufacturing sites since 2018, Indian companies are stepping in to fill the supply gap. However, the opportunity is unfolding amid growing strategic discipline. Filings of Abbreviated New Drug Applications (ANDAs) in the US declined 25 per cent year-on-year. FY25 filings are projected to close around 550—down from 740 in FY24 and 857 in FY22. This signals a pivot from volume to portfolio quality, regulatory compliance and margin protection. Commenting on this shift, Nilaya Varma, Group CEO and Co-founder of Primus Partners, said, 'India's pharma exports have grown from $15 billion in 2013–14 to nearly $28 billion in a decade. With 750+ USFDA-approved plants and rising strength in complex generics and biosimilars, India is primed to lead the next wave of affordable, high-quality medicines. Tapping the $180 billion LoE opportunity will require continued focus on compliance and quality systems.' Regulatory headwinds are also easing. The share of US FDA inspections resulting in Official Action Indicated (OAI) for Indian firms has fallen from 19 per cent in 2013 to 9 per cent in 2023. Companies like Cipla are further de-risking their US supply chains by adopting multi-site manufacturing and digital quality systems. Cipla, which holds a robust US portfolio of 284 ANDA and NDA filings—175 of which are approved and 73 under review—is focusing on commercialisation-ready products, including PEPFAR-approved generics. The company is betting on complex respiratory and injectable therapies to drive growth. Pharma major Lupin, which continues to benefit globally from its blockbuster autoimmune biologic Etanercept, plans to finalise its US commercialisation strategy closer to the drug's 2029 patent expiry. Meanwhile, Sun Pharma, despite offering a conservative FY26 outlook amid global macro uncertainties, is expanding its oncology pipeline. Its recently acquired UNLOXCYT (cosibelimab) is expected to significantly contribute to US revenues. The company noted that Keytruda's upcoming patent expiry was already factored into the acquisition. UNLOXCYT targets only one of Keytruda's multiple indications, and Sun remains confident in its potential to become a meaningful contributor to its US specialty business. In parallel, Sun is also strengthening its immunotherapy portfolio through a global licensing agreement with Philogen.
Business Upturn
10-06-2025
- Business
- Business Upturn
OneSource Specialty Pharma shares jump 3% after USFDA grants VAI classification for its Bangalore facility
By Aman Shukla Published on June 10, 2025, 09:22 IST Shares of OneSource Specialty Pharma Ltd jumped 3% in morning trade on June 10 after the company announced that its flagship facility in Bangalore received a 'Voluntary Action Indicated' (VAI) classification from the U.S. Food and Drug Administration (USFDA). As of 9:21 AM, the shares were trading 3.61% higter at Rs 2,002.70. The classification follows a routine USFDA inspection conducted from March 20 to March 28, 2025. At the end of the inspection, the agency issued a Form 483 with four observations. The company responded with a comprehensive corrective action plan. After reviewing the response, the USFDA designated the outcome as VAI, indicating that while issues were noted, they were not serious enough to trigger regulatory or enforcement action. The VAI status also confirms that the inspection is now officially closed. The company did not disclose the specific details of the observations, but emphasized that the facility remains integral to its core manufacturing and development operations. A VAI classification is generally seen as a positive regulatory outcome, especially compared to more severe classifications like 'Official Action Indicated' (OAI). Investors reacted favorably to the news, pushing the stock higher. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
