Glenmark says the FDA may reinspect its Monroe site at any moment.
Glenmark, an Indian pharmaceutical company, recently reported its earnings for the 2025 financial year. While the company’s overall performance was affected by a weak second half in its India business, it is planning to revive growth in both its core markets: India and the US. One of the key strategies to achieve this goal is by seeking approval for a generic version of a popular inhaler, Flovent, which is used to treat respiratory diseases such as asthma.
The company is expecting to receive approval for its Flovent rival in the next three months. This is a significant development as Flovent is a widely prescribed medication, and a generic version could help Glenmark tap into this lucrative market. Glenmark has already filed for approval with the US FDA and is confident of receiving a positive response.
In addition to this, Glenmark is also focusing on strengthening its product portfolio in the US market. The company has a robust pipeline of products in various stages of development, including several generic versions of popular medications. Glenmark is also planning to file for approval of more products in the coming months, which is expected to further boost its growth prospects.
In India, Glenmark is planning to revive growth by launching new products and increasing its focus on the chronic therapy segment. The company has a strong presence in the Indian market, and its products are widely prescribed by doctors. Glenmark is also planning to increase its marketing efforts and expand its distribution network to reach more customers.
Overall, while Glenmark’s earnings were affected by a weak second half in its India business, the company is well-placed to return to growth in the coming months. With a strong pipeline of products, a robust marketing strategy, and a focus on expanding its presence in both the US and Indian markets, Glenmark is poised to achieve significant growth in the future. The company’s plans to launch a generic version of Flovent and file for approval of more products are expected to be key drivers of growth, and investors will be watching the company’s progress closely in the coming months.
Aurobindo gains FDA approval for generic version of Pfizer’s Chantix
The US Food and Drug Administration (FDA) has granted approval to Aurobindo Pharma for its varenicline tablets, available in 0.5 mg and 1 mg strengths. This approval marks a significant milestone for Aurobindo, as its varenicline tablets are the generic equivalent of PF Prism C.V.’s Chantix Tablets. The FDA’s green light allows Aurobindo to commercially manufacture and distribute its varenicline tablets, providing patients with a more affordable treatment option for smoking cessation.
Varenicline tablets are specifically designed to aid individuals in quitting smoking, a habit that poses significant health risks. Smoking is a leading cause of preventable deaths worldwide, and quitting can greatly reduce the risk of developing smoking-related illnesses, such as heart disease, lung cancer, and chronic obstructive pulmonary disease (COPD). The varenicline tablets work by reducing cravings for nicotine and blocking the pleasurable effects of smoking, making it easier for individuals to quit.
Aurobindo’s varenicline tablets have undergone rigorous testing and have demonstrated bioequivalence to Chantix Tablets, ensuring that they are therapeutically equivalent and can be used interchangeably. The FDA’s approval of Aurobindo’s varenicline tablets is a testament to the company’s commitment to providing high-quality, affordable generic medications to patients.
The availability of generic varenicline tablets is expected to increase access to smoking cessation treatment, particularly for individuals who may not have been able to afford the brand-name medication. Aurobindo’s varenicline tablets will be marketed at a lower price point than Chantix Tablets, making it a more accessible option for patients. This approval is also expected to drive competition in the market, leading to lower prices and increased innovation in the development of smoking cessation treatments.
Overall, the FDA’s approval of Aurobindo’s varenicline tablets marks a significant step forward in the fight against smoking-related illnesses. By providing a more affordable and accessible treatment option, Aurobindo is helping to make a positive impact on public health. As the company continues to expand its portfolio of generic medications, it is likely to play an increasingly important role in improving access to healthcare for patients around the world.
Biocon to introduce its approved generic version of Liraglutide in the Indian market promptly.
Biocon, a leading biopharmaceutical company, has announced the launch of its first vertically integrated GLP-1 product in India, a generic version of liraglutide. The company believes that GLP-1s will be the key drivers of its future growth, and this launch marks a significant milestone in its strategy to expand its presence in the diabetes care market.
The generic liraglutide, which is a glucagon-like peptide-1 (GLP-1) receptor agonist, has been approved by the Central Drugs Standard Control Organisation (CDSCO) under Rule 101. This rule recognizes approvals from established and referenced serious regulatory authorities, such as the US FDA and the European Medicines Agency. The approval is based on Biocon’s own clinical trials and data, demonstrating the efficacy and safety of the product.
The launch of generic liraglutide in India is expected to increase access to this important medication for patients with type 2 diabetes. GLP-1s, such as liraglutide, have been shown to be effective in improving glycemic control, reducing body weight, and lowering the risk of major adverse cardiovascular events. With the growing prevalence of diabetes in India, the demand for effective and affordable treatments is on the rise.
Biocon’s vertically integrated business model, which involves developing and manufacturing its own products, is expected to enable the company to offer high-quality GLP-1s at competitive prices. The company has a strong presence in the Indian pharmaceutical market and is well-positioned to leverage its expertise and capabilities to drive growth in the GLP-1 segment.
The launch of generic liraglutide is part of Biocon’s broader strategy to expand its portfolio of diabetes care products. The company has a pipeline of several GLP-1 products in development, including biosimilars and novel molecules. With its strong research and development capabilities, Biocon is committed to developing innovative and affordable treatments for patients with diabetes and other chronic diseases.
Overall, the launch of generic liraglutide in India marks an important milestone for Biocon and demonstrates its commitment to increasing access to effective and affordable treatments for patients with diabetes. The company’s focus on GLP-1s is expected to drive growth and expansion in the coming years, and its vertically integrated business model is well-positioned to deliver high-quality products at competitive prices.
Sekhmet Pharma, owned by private equity, appoints ex-Lupin and Shilpa Medicare executive as its new chief executive officer.
A private equity consortium led by PAG, an Asia-focused investment firm, has announced the appointment of Santosh Kumar Mahil as the Managing Director and CEO of Sekhmet Pharmaventures Pvt Ltd. Mahil replaces Anil Khubchandani, who was appointed to the role in 2023. With nearly three decades of experience in the pharmaceutical industry, Mahil brings a wealth of knowledge and expertise to his new role.
Mahil’s experience spans the entire pharmaceutical value chain, including active pharmaceutical ingredients (APIs), formulations, intermediates, and contract development and manufacturing (CDMO) services. He has held leadership roles at several prominent pharmaceutical companies, including Lupin, USV, Unichem, and Shilpa Medicare. In his most recent role, he served as CEO of Shilpa Pharma Life Sciences, an R&D and manufacturing subsidiary of Shilpa Medicare.
Sekhmet Pharmaventures is an investment platform established to support the next generation of API companies. It is the India arm of Gamot API Pte Ltd, a Singapore-based platform launched by PAG, along with Indian private equity firms CX Partners and Samara Capital. Sekhmet’s platform includes Chennai-based Anjan Drug Pvt Ltd and the Optimus Drugs Group of Companies, both of which are API manufacturers that emphasize global standards of quality and regulatory compliance.
As of March 2024, Sekhmet Pharma reported net sales of Rs 1,035 crore, a slight increase from Rs 1,004 crore in the previous year. The company’s net loss narrowed to Rs 190 crore from Rs 256 crore in March 2023. The appointment of Mahil as CEO is expected to help drive growth and expansion at Sekhmet Pharmaventures. His experience and expertise in the pharmaceutical industry will be invaluable in leading the company’s efforts to support the next generation of API companies.
The appointment of Mahil also follows the elevation of Nikhil Srivastava, partner and India head of PE at PAG, to co-head of the firm’s global PE business. This move is seen as a sign of PAG’s commitment to expanding its presence in the Indian market and supporting the growth of companies like Sekhmet Pharmaventures. With Mahil at the helm, Sekhmet Pharmaventures is well-positioned to capitalize on opportunities in the API market and drive growth and innovation in the pharmaceutical industry.
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