Glenmark Pharmaceuticals has received a nod from a CDSCO (Central Drugs Standard Control Organization) panel to conduct clinical trials in India for its new investigational drug combination, Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation. This development is significant for the company as it prepares to enter the lucrative market for respiratory treatment.

Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation is a bronchodilator powder for inhalation, indicated for the treatment of chronic obstructive pulmonary disease (COPD). The drug combines the three active pharmaceutical ingredients (APIs) – glycopyrronium, fluticasone furoate, and vilanterol – in a single disposable inhaler. This trifecta of APIs aims to provide a comprehensive treatment approach to address the cardinal symptoms of COPD, including bronchospasm, chronic bronchitis, and emphysema.

The CDSCO panel’s approval enables Glenmark to conduct Phase III clinical trials in India, marking a significant milestone in the drug’s development journey. The trials will assess the safety and efficacy of the drug in treating patients with COPD.

Glenmark’s decision to conduct clinical trials in India reflects the country’s growing importance as a hub for pharmaceutical research and development. India has a large patient pool and a vibrant pharmaceutical sector, which provides an attractive environment for companies to conduct trials. The CDSCO’s approval is a testament to the country’s growing reputation as a destination for clinical trials.

Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation is not the only respiratory treatment on the market. However, the combination of three APIs in a single inhaler differentiates it from other available treatments. The drug has the potential to become a game-changer in the treatment of COPD, providing patients with a more convenient and effective treatment option.

Glenmark’s strategy to develop a treatment for COPD is part of its broader efforts to strengthen its presence in the respiratory segment. The company has a growing portfolio of products in this space, with a focus on delivering innovative solutions for patients.

The development of Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation is a significant achievement for Glenmark, given the challenges associated with conducting clinical trials. The approval from the CDSCO panel is a major step towards getting the drug approved for commercialization in India.

In conclusion, Glenmark’s receipt of CDSCO panel approval to study Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation for COPD treatment is a significant development in the Indian pharmaceutical industry. The company’s efforts to develop a comprehensive treatment for COPD are a testament to its commitment to innovation and patient care. As the clinical trials progress, patients in India and globally can expect a new treatment option that has the potential to revolutionize the way COPD is managed.

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Alivus Life Sciences Limited, formerly Glenmark Life Sciences Limited, is a India-based company that develops and manufactures non-commoditized active pharmaceutical ingredients (APIs) in chronic therapeutic areas. The company provides contract development and manufacturing (CDMO) services to multinational and specialty pharmaceutical companies. Their primary areas of focus include cardiovascular disease, central nervous system disorders, diabetes, oncology, pain management, and anti-infectives.

In addition to these areas, Alivus also develops APIs for antifungal, anti-histaminic, anti-acne, anti-emetic, ophthalmologic agent, urinary, and anti-spasmodic treatments. The company has a diverse portfolio of around 151 molecules and supplies its products to customers in various regions around the world, including India, Europe, North America, Latin America, Japan, and the rest of the world.

Alivus has four manufacturing facilities located in Ankleshwar, Dahej, Mohol, and Kurkumbh, which enables the company to meet the diverse needs of its customers. With a strong presence in the pharmaceutical industry, Alivus is well-positioned to continue growth and expansion in the future.

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Glenmark Pharmaceuticals, USA has launched Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial). This product is bioequivalent and therapeutically equivalent to the reference listed drug, Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial of Mylan Laboratories Limited.

The market for Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial) has achieved annual sales of approximately $39.3 million, according to IQVIA sales data for the 12-month period ending January 2025.

Marc Kikuchi, President & Business Head, North America at Glenmark, commented on the launch, saying, “We are excited to announce the launch of Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial), adding another quality product to our institutional portfolio.”

This launch further solidifies Glenmark’s position as a prominent player in the pharmaceutical industry, driven by its commitment to providing high-quality and innovative products to patients. At a time when the pharmaceutical industry is witnessing significant changes, Glenmark’s launch of Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial), demonstrates its dedication to delivering quality medication to patients.

Glenmark has announced the launch of its generic version of Mylan’s Vancomycin Hydrochloride for Injection, which is now available in three concentrations: 750 mg/vial, 1.25 g/vial, and 1.5 g/vial (Single-dose vial). According to IQVIA, the market value of Vancomycin Hydrochloride for Injection for the 12-month period ending January 2025 was approximately $39.3 million. This suggests that the demand for this product is significant and that Glenmark’s generic version is well-positioned to capitalize on the market opportunity.

Glenmark’s president and business head, North America, Marc Kikuchi, expressed enthusiasm about the launch, stating, “We are excited to announce the launch of Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial), adding another quality product to our institutional portfolio.” This launch demonstrates Glenmark’s commitment to expanding its portfolio of generic products and providing patients with affordable alternatives to branded medications.

Vancomycin Hydrochloride for Injection is a critically important antibiotic used to treat serious infections caused by susceptible gram-positive bacteria. The new generic version from Glenmark offers a cost-effective solution for hospitals, clinics, and other healthcare institutions. With its established reputation for producing high-quality generic medications, Glenmark is well-positioned to make a positive impact in the market with its new product. The company’s entry into the market with this generic product is expected to promote increased competition, which can lead to lower prices and improved access to treatment for patients.

A UK High Court Judge, Michael Tappin, has rejected a request by AstraZeneca (AZ) and AstraZeneca UK Ltd. for an interim injunction to block Glenmark Pharmaceuticals Europe from launching a generic version of AZ’s diabetes drug, Forxiga. The generic version, which contains the same active ingredient as Forxiga (dapagliflozin), was set to be launched before the resolution of a related UK lawsuit in which Glenmark is seeking a declaration of patent invalidity. AZ had argued that the launch would cause them irreparable harm, but Tappin disagreed, stating that AZ’s potential losses could be adequately compensated with monetary damages.

Instead, Tappin placed a condition on Glenmark, recommending that they pay a sum of money “into a separate bank account for each pack sold” until a hearing on injunctive relief is held in the validity trial. This decision allows Glenmark to proceed with the launch of its generic version of Forxiga, while also providing some protection for AZ’s business interests.

The outcome of this case is significant for the pharmaceutical industry, as it highlights the complexities of patent infringement and the balance between competing interests in the market. It also underscores the need for companies to carefully consider the potential risks and consequences of launching a generic version of a patented product.

Glenmark Pharmaceuticals Ltd., a leading research-led, global pharmaceutical company, has partnered with Health Futures Foundation, Inc. (HFI) and the Municipality of Malinao to launch a comprehensive initiative to improve nutrition among children and pregnant/lactating women in the Philippines. The program, titled “Food Supplementation and Capacity Building Support for Improved Nutrition in Malinao, Aklan,” aims to reduce the number of malnourished children aged 0-5 years and support nutritionally-at-risk pregnant and lactating women.

The initiative will cover 23 barangays and will focus on providing dietary supplementation, nutrition gardening, and capacity-building for local health workers to enhance their ability to educate families on maternal and child nutrition, safe motherhood, and hygiene practices. The program aims to impact nearly 25,000 beneficiaries.

The launch of the initiative, attended by local officials and representatives from Glenmark and HFI, emphasized the importance of collaboration between government and private sectors to address the issue of malnutrition. Participants also emphasized the need for sustained efforts to break the cycle of malnutrition.

Glenmark’s Country Manager, Adeel Hasan, stated that addressing child malnutrition and maternal health is essential for the Philippines’ development, and that the company’s partnership with local government and HFI will ensure a tailored and effective intervention.

The program’s success will be based on its three key interventions: dietary supplementation, nutrition gardening, and capacity-building. It is expected to be a sustainable solution to address the issue of malnutrition and ensure long-term impact.

Glenmark and HFI are committed to working together to improve the health and well-being of marginalized communities in the Philippines, with the goal of scaling up the initiative to other underserved areas.

Glenmark has received FDA clearance for its generic version of Alcon’s Pataday Once Daily Relief Ophthalmic Solution, olopatadine hydrochloride ophthalmic solution 0.2% over-the-counter (OTC). This generic medication will be distributed in the US by Glenmark Therapeutics, USA. The Pataday Once Daily Relief Ophthalmic Solution market had sales of approximately $50.7 million in the latest 52 weeks period ending February 22, 2025, according to Nielsen syndicated data. Marc Kikuchi, president and business head of North America at Glenmark, expressed his company’s excitement to expand its OTC ophthalmic portfolio, emphasizing its commitment to meeting market needs and providing high-quality OTC solutions for customers.

The approval of Glenmark’s olopatadine hydrochloride ophthalmic solution 0.2% OTC marks another significant milestone for the company, which has been actively expanding its presence in the OTC market. The company has a strong pipeline of products in various stages of development, with a focus on providing high-quality, affordable, and innovative solutions to patients. The availability of this generic medication will cater to the growing demand for affordable and effective eye care products, bringing relief to patients suffering from allergies, itchy, red, and watery eyes.

By offering a generic version of Pataday, Glenmark is expected to increasing access to this medication, making it more convenient and cost-effective for patients to manage their ophthalmic conditions. The company’s commitment to innovation, quality, and customer satisfaction has earned it a reputation as a reliable player in the pharmaceutical industry, further solidifying its position as a major player in the OTC market.

Glenmark Pharma has announced that its US subsidiary, Glenmark Therapeutics Inc., has received approval from the US Food and Drug Administration (USFDA) for its Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC). This approval allows Glenmark to market the product in the US market, expanding its ophthalmic portfolio. The product is bioequivalent to Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC), developed by Alcon Laboratories, Inc.

This approval is significant, as the Pataday brand is a popular treatment for relieving itchy, red, and irritated eyes. The annual sales of the Pataday product in the US market reached approximately $50.7 million, according to Nielsen syndicated data for the 52 weeks ending February 2025. Glenmark’s President and Business Head of North America, Marc Kikuchi, expressed his excitement about expanding the company’s over-the-counter (OTC) ophthalmic portfolio, stating that it reaffirms Glenmark’s commitment to providing high-quality, OTC eye care solutions for consumers.

The approval of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC) marks a significant milestone for Glenmark Therapeutics Inc. in the US market. With this product, Glenmark is well-positioned to capitalize on the growing demand for OTC eye care solutions, providing consumers with a reliable and effective treatment option for their eye care needs.

Glenmark Pharmaceuticals has launched Empagliflozin, a widely recognized SGLT2 inhibitor, in India under the brand name Glempa. The company has introduced three treatment options: Glempa (Empagliflozin 10/25 mg), Glempa-L (Empagliflozin 10/25 mg + Linagliptin 5 mg), and Glempa-M (Empagliflozin 12.5 mg + Metformin 500/1000 mg). These medications are designed to improve glycemic control in adults with type 2 diabetes (T2DM) and reduce cardiovascular outcomes in T2DM patients with cardiovascular risks.

Empagliflozin has been shown to be effective in reducing major cardiovascular events by 14% and has also been found to be effective in reducing weight and blood sugar levels in patients with T2DM. The medication has also been shown to be safe and well-tolerated in clinical trials.

Glenmark’s Glempa range is designed to cater to diverse patient needs, offering a standalone SGLT2 inhibitor, a dual-action therapy combining an SGLT2 inhibitor with a DPP4 inhibitor, and a combination therapy combining SGLT2 inhibition with metformin. The company aims to provide affordable, high-quality treatment options, improving health outcomes for millions of patients across India.

Commenting on the launch, Alok Malik, President and Head of India Formulations Business, Glenmark Pharmaceuticals Ltd, said: “Glenmark has a strong legacy of introducing innovative and accessible treatments for Cardiometabolic care in India. The launch of Glempa range reinforces this commitment by providing a comprehensive and affordable solution that empowers healthcare professionals and patients to manage T2DM with established CVD more effectively.”

Glenmark Pharmaceuticals Ltd. has launched its new product range, Glempa, in India. The range consists of Empagliflozin, a widely recognized SGLT2 inhibitor, in three forms: Glempa (Empagliflozin 10/25 mg), Glempa-L (Empagliflozin 10/25 mg + Linagliptin 5 mg), and Glempa-M (Empagliflozin 12.5 mg + Metformin 500/1000 mg). These medications are designed to improve glycemic control in adults with type 2 diabetes (T2DM) and reduce cardiovascular outcomes in T2DM patients with cardiovascular risk.

Empagliflozin is a well-established treatment for heart failure, T2DM, and T2DM with cardiovascular disease, offering multiple benefits such as cardiovascular and renal safety. A clinical trial demonstrated a 14% reduction in major cardiovascular events, making Empagliflozin a significant advancement in T2DM patients with high CV risks.

Studies have shown that Empagliflozin and its combinations are effective in reducing blood sugar levels, weight loss, and fasting blood sugar. A study found that a combination of Empagliflozin and Metformin helped patients lower their blood sugar levels, lose weight, and reduce fasting blood sugar. Another study showed that Empagliflozin with Linagliptin helped patients lower their HbA1c, lose weight, and reduce fasting blood sugar, proving more effective than either medicine alone.

Alok Malik, President and Head of India Formulations Business, Glenmark Pharmaceuticals Ltd., commented on the launch, stating that Glenmark is committed to providing innovative and accessible treatments for cardiometabolic care in India. The launch of the Glempa range reinforces this commitment by providing a comprehensive and affordable solution for healthcare professionals and patients to manage T2DM with established CVD more effectively.

The Glempa range is designed to cater to diverse patient needs by offering three treatment options that enhance treatment flexibility and effectiveness. The Glempa range is expected to empower healthcare professionals and patients to manage T2DM with CVD more effectively, providing a range of treatment options for improved patient care.

Glenmark Therapeutics Inc., a US-based company, has announced the launch of Polyethylene Glycol 3350, Powder for Solution, 17 grams/capful (OTC), a product that is comparable to the active ingredient in MiraLAX Powder for Solution, 17 grams from Bayer HealthCare LLC. According to Nielsen data, the MiraLAX product achieved annual sales of approximately $555.7 million in the latest 52-week period ending February 22, 2025.

The new product marks Glenmark’s entry into the market, which is expected to cater to the growing demand for a new supplier in this category. Marc Kikuchi, President & Business Head, North America at Glenmark, expressed excitement about the launch, stating that it reflects the company’s commitment to meeting market needs and providing high-quality over-the-counter solutions for its customers.

The launch of Polyethylene Glycol 3350, Powder for Solution, 17 grams/capful is expected to give Glenmark a foothold in the market, which has been dominated by MiraLAX. The company’s entry into this category is a significant development, and it will be interesting to see how the market responds to this new competitor. With its commitment to providing high-quality products, Glenmark is likely to make a positive impact in the market. As the company continues to expand its portfolio, it will be worth monitoring to see how it fares in the competitive OTC market.

Mahavir International’s “Project Vatsalya – Pregnancy to Infancy” has been recognized for its outstanding efforts in eradicating malnutrition among women and children. The initiative received the prestigious Glenmark Nutrition Award 2025, which comes with a grant of Rs 2 lakh to support the expansion of the project. The award was established by the Glenmark Foundation and IDBRO to recognize organizations working towards eliminating malnutrition among pregnant and lactating women and children. Out of 403 nominations from across the country, Mahavir International’s Project Vatsalya was judged to be the best in the voluntary open category.

Dr. Veera Rashmi Saraswat, International Director of Women & Child Welfare – Vatsalya, presented the project to the grand jury in Mumbai, highlighting its efforts to combat malnutrition. The initiative is part of the National Nutrition Mission (Poshan Abhiyaan) and has been working tirelessly to address the issue of malnutrition among women and children. The award is a testament to the project’s dedication and commitment to improving the lives of these vulnerable groups.

The grant of Rs 2 lakh will enable Mahavir International to further extend the reach and impact of Project Vatsalya, making it a significant step towards a malnutrition-free society. The recognition is a proud moment for the organization, and Dr. Saraswat emphasized that the team will continue to work towards addressing this critical issue, which affects not only individual health but also the overall development of the country. With this award, Mahavir International’s Project Vatsalya has set a shining example for organizations working towards a similar cause, and its success will undoubtedly inspire others to follow in its footsteps.