However, challenges persist, particularly in North America, where revenue growth was modest at 1.4% due to price erosion, intense competition, and delays in complex injectable launches pending FDA approval for its Monroe plant. The company also faced a setback with a 6% share price drop after a USFDA recall of 39 drugs in April 2025. To enhance efficiency, Glenmark retrenched over 100 personnel from its consumer care division and is navigating a $7 million settlement for anti-trust lawsuits in the U.S.
Strategically, Glenmark is pivoting toward innovation, with its research arm, Ichnos Glenmark Innovation (IGI), nearing self-funding through potential out-licensing of its cancer asset ISB-2001. The company’s commitment to sustainability, evidenced by Science Based Targets initiative (SBTi) approval for GHG emission reductions, enhances its long-term appeal. With a 49% stock price rise over the past year (outperforming Nifty Pharma) and a P/E ratio of 16.33, Glenmark appears undervalued but faces risks from U.S. market volatility and regulatory hurdles. Its focus on high-growth segments like respiratory and injectables, alongside cost optimization, positions it for sustained growth, provided it navigates regulatory and competitive challenges effectively.
Latest News on Glenmark Pharma
The U.S. FDA issues five observations to Glenmark Pharma’s North Carolina manufacturing facility.
The U.S. Food and Drug Administration (FDA) recently conducted a Good Manufacturing Practice (GMP) inspection of Glenmark Pharmaceuticals’ manufacturing facility in Monroe, North Carolina. The inspection, which took place from June 9-17, resulted in the FDA issuing a Form 483 with five observations. A Form 483 is a report detailing any conditions or practices that may be violating FDA regulations.
According to Glenmark Pharmaceuticals, the observations listed in the Form 483 are procedural in nature, meaning they relate to the company’s procedures and processes, rather than any issues with data integrity. Data integrity refers to the accuracy, completeness, and reliability of data, and is a critical aspect of pharmaceutical manufacturing.
The company has stated that it will work closely with the FDA to address the observations and respond to them within the required timeline. This response will likely involve implementing corrective actions to rectify the issues identified by the FDA. Glenmark Pharmaceuticals is committed to ensuring that its manufacturing facility meets the highest standards of quality and compliance.
It’s worth noting that receiving a Form 483 is not uncommon, and it does not necessarily indicate a major problem with a company’s manufacturing facility. Rather, it is an opportunity for the company to identify and correct any issues, and to ensure that its procedures and processes are in line with FDA regulations.
The fact that the observations are procedural in nature, rather than related to data integrity, is a positive sign. Data integrity issues can be serious and may indicate a more systemic problem with a company’s manufacturing practices. In contrast, procedural issues are often easier to address and may be a matter of clarifying or updating procedures, rather than indicating a deeper problem.
Overall, Glenmark Pharmaceuticals is taking a proactive approach to addressing the FDA’s observations and ensuring that its manufacturing facility meets the required standards. The company’s commitment to quality and compliance is a positive sign, and it is likely that the issues identified by the FDA will be resolved in a timely and effective manner.
Glenmark Pharma’s Chairman and Managing Director emphasized the importance of maintaining concentration and undertaking initiatives that are on par with global standards.
Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd, reflects on the company’s over two-decade journey, highlighting the challenges of transitioning from a generic-focused business to a more innovative space. Saldanha notes that this transition is not for the faint-hearted, requiring significant effort and perseverance. Glenmark has been working towards this goal for 25 years, with its innovative pipeline, including the Ichnos Glenmark Innovation (IGI) alliance, yielding promising results, such as the ISB 2001 drug candidate.
The company has created a strong foundation in three therapeutic areas, with a global footprint and a robust India business, generating ₹13,500-14,000 crore in revenue last year. However, Saldanha acknowledges the unpredictability of global policies, particularly in the US, which can impact the pharmaceutical industry. Despite these challenges, he believes that Indian players, including Glenmark, have upside potential due to their cost competitiveness and strong foundation.
Glenmark is poised to announce a “transformational” licensing deal for its ISB 2001 drug candidate, which has the potential to transform therapy in the multiple myeloma space. The company is focused on staying globally competitive, driving efficiencies, and allocating resources effectively. Saldanha also addressed the company’s restructuring efforts, including the closure of its Switzerland facility and changes to its consumer healthcare business, stating that these moves are part of normal business operations aimed at driving growth and efficiency.
The ISB 2001 drug candidate is a significant development for Glenmark, with the potential to extend life and improve treatment outcomes for patients with multiple myeloma. The company is confident about the prospects of this candidate and is working towards a licensing deal, which is expected to happen soon. Overall, Glenmark is well-positioned for growth, with a strong foundation, innovative pipeline, and focus on global competitiveness. Despite the challenges and uncertainties in the pharmaceutical industry, Saldanha remains optimistic about the company’s future prospects.
Glenmark introduces Zanubrutinib, a novel cancer treatment, to the Indian market
Glenmark Pharmaceuticals, a renowned drug company, has announced its plan to launch a cancer treatment drug called zanubrutinib, also known as Brukinsa, in India. The drug has been approved by the Drugs Controller General of India (DCGI) and will be used to treat five special B-cell malignancies, including chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma. This makes it the first and only Bruton’s tyrosine kinase (BTK) inhibitor to be legitimized in India for these treatments.
The drug has already been approved for use in over 60 countries, including major markets like the United States, China, the European Union, and Canada. Zanubrutinib works by blocking the action of unhealthy proteins that signal cancer cells to multiply, helping to stop the spread of cancer cells. It is classified as a tyrosine kinase inhibitor (TKI) and specifically targets the protein Bruton’s tyrosine kinase, making it a Bruton tyrosine kinase inhibitor (BTKi).
Glenmark Pharmaceuticals has a history of innovative drug launches, including a medication for glycemic control and weight loss for diabetes patients, called Empagliflozin, under the brand name Glempa. The company has also launched fixed-dose combinations of Empagliflozin, which have been shown to improve glycemic control, aid in weight loss, and reduce cardiovascular outcomes in patients with type 2 diabetes mellitus.
The launch of zanubrutinib in India marks a significant milestone in Glenmark’s innovative oncology portfolio and offers patients in India access to a globally trusted therapy with proven efficacy and safety. Alok Malik, President and Business Head of Glenmark Pharmaceuticals, expressed the company’s enthusiasm for bringing Brukinsa to India, stating that it will be a significant addition to their innovative oncology portfolio.
The introduction of zanubrutinib in India is expected to change the face of cancer treatment in the country, offering new hope and possibilities for patients. With its proven efficacy and safety, the drug has the potential to make a significant impact on the lives of those affected by cancer. As Glenmark continues to innovate and expand its portfolio, the company remains committed to providing access to globally trusted therapies and improving the lives of patients in India and around the world.
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.
Glenmark Pharmaceuticals’ (NSE:GLENMARK) financial results appear less impressive upon closer examination.
Glenmark Pharmaceuticals’ latest earnings report may appear impressive at first glance, but a closer examination reveals some underlying weaknesses. The company’s net profit increased by 15.6% year-over-year, reaching ₹2.16 billion, and revenue grew by 7.2% to ₹27.45 billion. However, these numbers are not as strong as they seem.
One major concern is the decline in the company’s operating margins, which fell to 13.4% from 15.4% in the same quarter last year. This decrease is largely due to higher research and development expenses, which rose by 34.4% year-over-year. While investing in R&D is essential for pharmaceutical companies, the significant increase in expenses has put pressure on Glenmark’s profitability.
Another issue is the company’s dependence on a few key products, which account for a significant portion of its revenue. The sales of these products have been declining, and Glenmark has not been able to offset this decrease with new launches or growth in other areas. This dependence on a limited number of products makes the company vulnerable to market fluctuations and competition.
Furthermore, Glenmark’s debt has increased, with a debt-to-equity ratio of 0.45, up from 0.34 in the previous year. The company’s interest expenses have also risen, which has further eroded its profitability. Glenmark’s return on equity (ROE) has declined to 12.1% from 14.1% in the same quarter last year, indicating a decrease in the company’s ability to generate profits from its shareholders’ capital.
In addition, Glenmark’s guidance for the full year is cautious, with the company expecting revenue growth of 8-10% and operating margin expansion of 50-100 basis points. This guidance is lower than analyst expectations, which could lead to a negative reaction from investors.
Overall, while Glenmark Pharmaceuticals’ latest earnings report may appear strong at first glance, a closer examination reveals several underlying weaknesses. The company’s declining operating margins, dependence on a few key products, increasing debt, and declining ROE are all causes for concern. Glenmark needs to address these issues to achieve sustainable growth and improve its profitability in the long term. Investors should exercise caution and carefully evaluate the company’s prospects before making any investment decisions.
Stock Market Updates for Glenmark Pharma
Recent Updates
Glenmark Pharmaceuticals Sees Significant Profit Increase in March 2025 Despite Elevated Interest Expenses – MarketsMojo
Glenmark Pharmaceuticals has announced its financial results for the fourth quarter and full year ended March 2025, highlighting a solid profit growth despite increasing interest costs. The company’s performance was driven by robust sales across its key markets and a strong product pipeline.
Revenue for the quarter ended March 2025 stood at ₹3,483.6 crore, representing a 13.4% year-over-year (YoY) growth. For the full year, revenue was ₹12,853.1 crore, up 12.1% YoY. The company’s operating profit (EBITDA) for the quarter was ₹731.4 crore, with a margin of 21%, while full-year EBITDA reached ₹2,631.4 crore.
Net profit for the quarter ended March 2025 was ₹356.2 crore, a significant increase of 25.5% YoY. However, the company’s interest costs rose to ₹133.8 crore during the quarter, up from ₹93.8 crore in the same period last year. This increase was primarily due to higher borrowing costs and an expansion of the company’s debt.
Glenmark’s formulations business, which accounts for the majority of its revenue, grew 14.1% YoY in the fourth quarter, driven by strong sales in the United States, Europe, and India. The company’s US business, in particular, showed significant growth, with revenue increasing by 23.1% YoY.
The company’s research and development (R&D) expenses for the quarter were ₹245.8 crore, representing 7.1% of revenue. Glenmark has a strong pipeline of products under development, with several new drug applications (NDAs) and abbreviated new drug applications (ANDAs) filed in various markets.
Glenmark’s management expressed confidence in the company’s growth prospects, citing a robust product pipeline, expanding global presence, and a strong balance sheet. The company is focused on investing in R&D and expanding its presence in emerging markets to drive long-term growth.
Overall, Glenmark Pharmaceuticals’ fourth-quarter and full-year results demonstrated the company’s ability to deliver strong profit growth despite rising interest costs. With a solid product pipeline and expanding global presence, the company is well-positioned for long-term success in the pharmaceutical industry. As the company continues to invest in R&D and expand its presence in emerging markets, investors will be closely watching its future performance to assess the sustainability of its growth trajectory.
PGIMER’s Transfusion Medicine Department Collects 117 Units of Blood, Sets Up Next Donation Camp at Glenmark Pharmaceuticals, Nalagarh on May 15
The Department of Transfusion Medicine at PGIMER, Chandigarh, recently conducted two blood donation camps in the city, with the goal of ensuring an adequate blood supply for patients in need. The first camp was held on May 14, 2025, at the Community Center in Manimajra, in association with the Chandigarh Municipal Corporation. Under the leadership of Dr. Suchet Sachdev, a total of 42 blood units were collected from volunteer donors.
A second camp was also held on the same day at the Community Centre in Sector 28, Chandigarh, in association with the Chandigarh Municipal Corporation. This camp, led by Dr. Ekta Paramjit, collected 75 blood units. The Department of Transfusion Medicine expressed its gratitude to all the donors who participated, noting that their contributions will help cater to the needs of critically ill patients in the institute.
The blood donation camps are part of the department’s ongoing efforts to ensure a steady supply of blood and blood components for patients. The donated blood will be used to support the treatment of patients at PGIMER, Chandigarh. The department is committed to continuing its life-saving mission and has scheduled another blood donation camp for May 15, 2025, in association with Glenmark Pharmaceuticals Ltd. The camp will be held at the company’s premises in Nalagarh, starting at 10:00 a.m.
Individuals interested in participating in the upcoming camp can contact the Senior Resident from PGIMER or Mr. Yash Pal for more information. The department encourages all eligible individuals to come forward and donate blood, as their contributions can help save lives. By supporting blood donation camps like these, individuals can make a significant difference in the lives of patients in need of blood transfusions. The Department of Transfusion Medicine is dedicated to continuing its efforts to ensure a safe and adequate blood supply, and the support of volunteer donors is crucial to achieving this goal.
NIVEA India names Akshay Kawale as new Business Unit Head – Derma
NIVEA India has appointed Akshay Kawale as the Business Unit Head of its Derma division, effective April 3, 2025. Kawale brings 16 years of experience in the industry, having worked with prominent organizations such as Glenmark Pharmaceuticals, Abbott, GSK, and L’Oréal. Most recently, he served as Business Head of Cosmetology at Glenmark Pharmaceuticals, where he played a key role in developing and scaling skincare business strategies.
In his new role at NIVEA, Kawale will be responsible for leading the Derma business unit for Eucerin, a brand known for its dermatological expertise and trust. Geetika Mehta, Managing Director of NIVEA India, expressed her delight at Kawale’s appointment, citing his deep understanding of the derma category and ability to drive business transformation as key assets in expanding Eucerin’s presence in India.
Mehta also highlighted Kawale’s consumer-first approach and strategic acumen as essential qualities to drive the next phase of growth for the brand. Kawale himself expressed his excitement to join Eucerin, a brand he admires for its global reputation in dermatological expertise and trust. He looks forward to contributing to the brand’s growth in India while staying true to its values of skincare science and care.
Kawale’s appointment is seen as a significant move by NIVEA India to strengthen its position in the derma category, particularly with the Eucerin brand. With his extensive experience and expertise, Kawale is expected to play a key role in driving business growth and expansion for Eucerin in India. The company is confident that Kawale’s leadership will help take the brand to new heights, building on its reputation for dermatological expertise and trust. Overall, the appointment of Akshay Kawale as Business Unit Head of Derma is a strategic move by NIVEA India to drive growth and expansion in the Indian market.
Glenmark Pharma’s oncology treatment gets expedited review with FDA’s ‘fast track’ designation
Glenmark Pharmaceuticals’ subsidiary, Ichnos Glenmark Innovation (IGI), has received a “fast track” designation from the United States Food and Drug Administration (USFDA) for its investigational therapy, ISB 2001. This therapy is intended for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
ISB 2001 is a tri-specific antibody therapeutic that targets BCMA and CD38 on myeloma cells, as well as CD3 on T cells, enabling a targeted immune response towards the cancer. The therapy is currently undergoing evaluation in a phase 1 dose expansion clinical study. IGI has recently concluded the dose increase portion of its phase 1 clinical study in patients with heavily pre-treated myeloma and plans to present the results from the dose escalation portion at the 2025 American Society of Clinical Oncology (ASCO) annual meeting.
The “fast track” designation from the USFDA is expected to expedite the development and review of ISB 2001, which could potentially lead to earlier approval and availability of the therapy for patients with RRMM. This designation is typically granted to therapies that have shown promise in treating serious or life-threatening conditions with limited treatment options.
In a separate development, Glenmark Pharmaceuticals has initiated a Class-II recall of 39 drugs from its US unit, which was classified as a Class-II recall on April 8, 2025. The recall was initiated in March 2025, and the company is taking steps to address the issue.
The development of ISB 2001 and the “fast track” designation from the USFDA represent a significant milestone for Glenmark Pharmaceuticals and its subsidiary, IGI. The company’s focus on innovation and research is expected to drive growth and expansion in the pharmaceutical industry. With the potential for earlier approval and availability of ISB 2001, patients with RRMM may have access to a new and potentially effective treatment option in the near future.
Glenmark’s UK approval of Dapagliflozin overturned on appeal as Teva prepared to enter the market
The UK Court of Appeal has overturned an earlier decision, granting AstraZeneca’s request for an injunction against Glenmark Pharmaceuticals’ generic version of the diabetes treatment Forxiga (dapagliflozin). This decision comes as a significant setback for Glenmark, which had been poised to launch its generic version of the medication in the UK.
The original ruling had denied AstraZeneca’s request for an injunction, allowing Glenmark to proceed with its plans to market a generic version of Forxiga. However, AstraZeneca successfully appealed the decision, arguing that the launch of Glenmark’s generic would infringe on its patent rights.
The UK Court of Appeal’s decision is a major victory for AstraZeneca, which can now prevent Glenmark from selling its generic version of Forxiga in the UK until the patent expiry date. This will allow AstraZeneca to maintain its market exclusivity for the medication, at least for the time being.
Glenmark had been expected to launch its generic version of Forxiga in the UK, which would have likely led to significant competition and price erosion for AstraZeneca’s branded product. The injunction will now block Glenmark’s plans, providing AstraZeneca with a temporary reprieve from generic competition.
The decision is also a significant development in the ongoing patent dispute between AstraZeneca and Glenmark. The two companies have been embroiled in a lengthy legal battle over the validity of AstraZeneca’s patent for Forxiga, with Glenmark arguing that the patent is invalid and AstraZeneca claiming that it is enforceable.
The UK Court of Appeal’s decision will likely have implications for the broader pharmaceutical industry, particularly in terms of the balance between patent protection and generic competition. The case highlights the complexities and uncertainties of patent litigation, where decisions can have significant consequences for companies and their products.
For now, AstraZeneca can breathe a sigh of relief, having successfully protected its patent rights and maintained its market exclusivity for Forxiga in the UK. However, the ongoing patent dispute with Glenmark is far from over, and further developments are likely to emerge in the coming months and years.
Indian pharmaceutical companies Sun Pharma, Zydus, and Glenmark have issued recalls of their products in the US due to manufacturing concerns.
Three major Indian pharmaceutical companies, Sun Pharma, Zydus, and Glenmark, have issued recalls of their products in the United States due to manufacturing issues. The recalls were announced by the US Food and Drug Administration (FDA) and cover a range of products, including generic versions of popular brand-name medications.
Sun Pharma, one of the largest pharmaceutical companies in India, has recalled over 55,000 bottles of its anti-epileptic medication, Brivaracetam Oral Suspension, due to contamination issues. The recall affects batches of the medication produced between May 2020 and January 2022.
Zydus, another prominent Indian pharmaceutical company, has recalled 72,000 bottles of its antipsychotic medication, Aripiprazole Oral Solution, due to issues with the medication’s potency. The recall affects batches of the medication produced between June 2020 and June 2021.
Glenmark, a smaller pharmaceutical company, has recalled 28,000 bottles of its antibiotic medication, Cephalexin Capsules, due to issues with the medication’s stability. The recall affects batches of the medication produced between July 2020 and November 2020.
The recalls were issued after the FDA received reports of contamination, potency issues, and stability problems with the affected products. The agency has instructed the companies to notify healthcare providers and patients taking the affected medications and to stop distributing the products until further notice.
While the recalls are ongoing, patients who are taking these medications should speak with their healthcare providers to discuss alternative treatment options and arrangements. The FDA will continue to monitor the situation and take further action as necessary to ensure the safety and effectiveness of the affected medications.
The recalls serve as a reminder of the importance of ensuring the quality and integrity of pharmaceutical products. The FDA’s action highlights the need for pharmaceutical companies to prioritize manufacturing quality and to take swift action to address any issues that may arise.
Glenmark secures CDSCO panel approval to investigate glycopyrronium, fluticasone furoate, and vilanterol powder for inhalation treatment.
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.
Alivus Life Sciences announces that its Ankleshwar facility has received a Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US FDA.
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.
Glenmark introduces a new injectable treatment option, vancomycin hydrochloride, addressing patient needs for effective antimicrobial solutions.
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.
Glenmark gains UK regulatory clearance to launch generic diabetes medication.
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 Introduces Groundbreaking Nutritional Initiative to Combat Malnutrition in the Philippines
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 gets FDA nod for over-the-counter generic version of Pataday
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 secures US FDA approval for Olopatadine Ophthalmic Solution
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.
India now has access to a new treatment option for type 2 diabetes management as Glenmark Pharmaceuticals launches Empagliflozin, a medication designed to effectively control the disease.
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 Pharma introduces Empagriflozin and its complementary formulations to the Indian market
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.
India sees a significant decrease in the price of a commonly used diabetes medication following the introduction of generic alternatives.
The price of the diabetes drug empagliflozin, also known as Jardiance, has been significantly reduced by almost one-tenth in India. The drug, developed by German pharma giant Boehringer Ingelheim, is used to control blood sugar levels in patients with type 2 diabetes. The original price of the drug was around Rs 60 per tablet, but with the entry of its generic versions in the market, it is now available for as low as Rs 5.5 per tablet.
Mankind, Alkem, and Glenmark Pharmaceuticals have launched generic versions of empagliflozin, with prices starting from Rs 5.49 per tablet for the 10 mg variant. These prices are nearly 80% lower than the original price of the innovator product. The generic versions of the drug come with additional features, such as anti-counterfeit security bands, patient education information, and QR codes that provide prescribing information and additional patient education.
The launch of these generic versions of empagliflozin is a significant step in making the drug more affordable for millions of Indians who are suffering from type 2 diabetes. India is known as the diabetes capital of the world, with over 10 crore people diagnosed with the disease, according to the Indian Council of Medical Research–India Diabetes (ICMR INDIAB) study in 2023. Reducing the cost of anti-diabetes medicines like empagliflozin is a crucial step in tackling the disease burden in the country.
Glenmark Therapeutics Inc. introduces Polyethylene Glycol 3350, a gentle, 17g/capful (OTC) powder for solution, now available in the USA.
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 receives prestigious ‘Glenmark Nutrition Award 2025’ in Nagpur
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.