
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
Delhi High Court bars Dr Reddy’s from producing VENUSIA sunscreens bearing the SUN logo.
The Delhi High Court has issued an interim order restraining Dr. Reddy’s Laboratories from manufacturing and selling its VENUSIA sunscreens with a label that includes the word “SUN”. The court’s decision comes in response to a lawsuit filed by Glenmark Pharmaceuticals, which claims that Dr. Reddy’s is infringing on its trademark rights.
Glenmark Pharmaceuticals had launched its own sunscreen product, SUNSTAR, in 2018, and had obtained a trademark registration for the mark “SUN” in relation to sunscreen products. The company claims that Dr. Reddy’s use of the word “SUN” on its VENUSIA sunscreens is likely to cause confusion among consumers and dilute the distinctiveness of Glenmark’s trademark.
The Delhi High Court has agreed with Glenmark’s arguments, observing that Dr. Reddy’s use of the word “SUN” on its products is likely to cause confusion among consumers, who may mistakenly believe that the VENUSIA sunscreens are connected to Glenmark’s SUNSTAR product. The court has therefore restrained Dr. Reddy’s from using the word “SUN” on its VENUSIA sunscreens, pending the outcome of the lawsuit.
The court’s order is a significant setback for Dr. Reddy’s, which had launched its VENUSIA sunscreens with the SUN label in an attempt to capitalize on the popularity of sunscreens in the Indian market. The company will now have to rebrand its products and remove the SUN label, which could result in significant losses and damage to its reputation.
The lawsuit highlights the importance of trademark protection in the pharmaceutical industry, where companies invest heavily in building their brands and trademarks. The Delhi High Court’s decision demonstrates that courts will take a strict view of trademark infringement, particularly in cases where there is a likelihood of confusion among consumers.
The case will now proceed to trial, where Glenmark will have to prove that Dr. Reddy’s use of the word “SUN” on its VENUSIA sunscreens constitutes trademark infringement. If the court ultimately rules in favor of Glenmark, Dr. Reddy’s could face significant damages and penalties for its alleged infringement. The case is being closely watched by the pharmaceutical industry, which is keen to see how the courts will interpret trademark laws in cases of alleged infringement.
Glenmark Pharmaceuticals USA has introduced a multiple-dose vial of epinephrine injection.
Glenmark Pharmaceuticals Inc, USA, has launched Epinephrine Injection USP, a bioequivalent and therapeutically equivalent product to the reference listed drug manufactured by BPI Labs, LLC. The product is available in a 30 mg/30 mL (1 mg/mL) Multiple-Dose Vial and is intended for the U.S. market. According to IQVIA sales data, the Epinephrine Injection market had annual sales of approximately USD 67.6 million for the 12 months ending October 2025. This launch expands Glenmark’s institutional product portfolio and reinforces its commitment to providing high-quality, affordable treatment options.
Glenmark Pharmaceuticals Limited is a prominent Indian multinational pharmaceutical company that has been in operation since 1977. The company has grown from its origins in generic medicines and active pharmaceutical ingredients (APIs) to become a research-led global healthcare organization with a presence in over 80 countries. Glenmark’s core therapeutic expertise includes respiratory, dermatology, oncology, cardiovascular, and anti-infective treatments, with multiple R&D centres and manufacturing facilities across India and internationally.
In recent years, Glenmark has diversified into innovative drug development and biosimilars, while maintaining a strong portfolio of branded generics in high-growth markets. The company has also entered strategic collaborations and licensing deals to advance novel therapies, particularly in oncology. Despite facing quality control challenges in some manufacturing facilities, Glenmark continues to pursue a transformation towards a more innovation-centric business model aimed at increasing its branded portfolio and long-term global competitiveness.
The launch of Epinephrine Injection USP is part of Glenmark’s strategy to strengthen its institutional channel presence and improve access to essential medicines. According to Marc Kikuchi, President and Business Head for North America at Glenmark, the launch supports the company’s commitment to providing high-quality, affordable treatment options. With its robust revenue growth and expanding demand in key markets such as North America and Europe, Glenmark is well-positioned to continue its growth and expansion in the global pharmaceutical market.
Glenmark secures $1 billion deal for multi-regional rights to Hansoh Pharma’s cancer treatment medication.
Glenmark Specialty S.A., a subsidiary of India-based Glenmark Pharmaceuticals, has entered into a licensing agreement with China’s Jiangsu Hansoh Pharmaceutical Group Co. for the oncology drug Aumolertinib. The agreement grants Glenmark exclusive rights to develop and commercialize Aumolertinib in several high-potential markets, including the Middle East, Africa, Southeast and South Asia, Australia, New Zealand, Russia, and the Caribbean. In return, Hansoh Pharma will receive an upfront payment of tens of millions of dollars, followed by potential milestone payments of over $1 billion, as well as tiered royalties on net sales.
Aumolertinib is a third-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) used to treat non-small cell lung cancer (NSCLC). The drug has already received marketing authorization in the UK and China, and has been approved for four indications in China. It is also marketed in the UK and Europe under the brand names Ameile and Aumseqa. The partnership strengthens Glenmark’s oncology strategy across these regions, providing access to a promising new treatment for patients with NSCLC.
The agreement marks a significant milestone for Hansoh Pharma, as Aumolertinib is the company’s first innovative drug to be approved in an overseas market. It is also the first China-developed EGFR-TKI to be launched internationally. The deal demonstrates the growing importance of partnerships between pharmaceutical companies to bring new treatments to market and expand their global reach. With the potential for milestone payments of over $1 billion, the agreement also highlights the significant value of innovative oncology treatments and the growing demand for effective therapies in this field. Overall, the partnership between Glenmark and Hansoh Pharma has the potential to bring a new and effective treatment option to patients with NSCLC in several regions, and marks an important step forward in the development of innovative oncology therapies.
A widely used blood pressure medication has been recalled due to concerns of potential contamination with a different pharmaceutical compound.
Glenmark Pharmaceuticals Inc. has issued a recall of over 11,100 bottles of its blood pressure medication, Ziac, due to potential cross-contamination with another drug. The medication, which is used to treat high blood pressure, also known as hypertension, may contain ezetimibe, a drug used to treat high cholesterol. The recall was initiated after testing of reserve samples revealed the presence of ezetimibe.
The affected pills come in 2.5mg and 6.25mg doses and are packaged in 30-count, 100-count, and 500-count bottles. The recall includes specific lot numbers with expiration dates ranging from November 2025 to May 2026. According to the Food and Drug Administration (FDA), the recall is classified as Class III, meaning that the use or exposure to the product is not likely to cause adverse health consequences.
Bisoprolol/hydrochlorothiazide, the active ingredients in Ziac, work by blocking beta-1 receptors in the heart, allowing it to return to a regular heartbeat. The medication is commonly used to treat high blood pressure, a condition that affects millions of people worldwide.
The FDA has not provided guidance on what patients should do if their medication is affected by the recall. The Independent has reached out to the FDA and Glenmark Pharmaceuticals for comment, but so far, no further information has been provided. Patients who are taking Ziac and are concerned about the recall should consult with their healthcare provider or pharmacist for advice on what to do next.
The recall highlights the importance of ensuring the quality and safety of pharmaceutical products. Cross-contamination can occur during the manufacturing process, and it is crucial for pharmaceutical companies to have rigorous testing and quality control measures in place to prevent such incidents. The FDA and pharmaceutical companies must work together to ensure that medications are safe and effective for patients to use.
The Future of Mexican Healthcare: Harnessing Data and Differentiation
Glenmark Pharmaceuticals has significantly expanded its presence in the “High Latin America” region, which includes Mexico, Colombia, Ecuador, Peru, Central America, and the Caribbean, over the past four years. The company’s growth in this region has been driven by innovation, product launches, and operational efficiency. In Mexico, Glenmark has nearly tripled its revenue, doubled its workforce, and expanded its sales force in recent years. The company attributes its success to its strategic use of data analytics, which enables it to identify high-growth therapeutic niches and make informed investment decisions.
Glenmark is also leveraging digitalization and telemedicine to accelerate research and adoption of new therapies. The company has a strong portfolio in respiratory care, dermatology, and oncology, and is focusing on launching innovative products in these areas. In Mexico, Glenmark is a market leader in oral solids and nasal sprays for allergic rhinitis, and has recently launched a new product that reached the number three position in nasal spray combinations within 10 months.
The company’s growth strategy also involves forming strategic alliances and co-development projects. Glenmark has established partnerships with local and regional laboratories to commercialize its molecules, and has also entered into collaborations with major pharmaceutical companies such as AstraZeneca. These partnerships allow Glenmark to expand its therapeutic coverage and maintain a robust pipeline of new products.
Over the next three to five years, Glenmark plans to launch a range of new products in respiratory, dermatology, and oncology. The company is committed to continuing to innovate and launch differentiated products that provide physicians with expanded therapeutic options and improve patient outcomes. In terms of digitalization, Mexico is seen as a strategic hub with enormous potential, offering greater business certainty and scalability than other Latin American countries.
Regulatory trends in Latin America are also influencing access to specialized therapies, with agencies increasingly adopting accelerated approval pathways and recognizing approvals from high-surveillance markets. Glenmark is preparing for these trends by digitalizing its processes and improving its regulatory capabilities. The company’s advice to other pharmaceutical companies operating in Mexico is to identify market niches, continuous innovation, and align investment decisions with long-term objectives. Overall, Glenmark’s position in Latin America is strong, and the company is well-placed to continue growing and expanding its presence in the region.
Stock Market Updates for Glenmark Pharma
Recent Updates
Glenmark Pharma’s manufacturing facility has successfully undergone a U.S. FDA inspection without receiving any observations.
Glenmark Pharmaceuticals, a prominent drugmaker, has successfully completed a pre-approval inspection by the U.S. Food and Drug Administration (FDA) at its formulations manufacturing facility in Chhatrapati Sambhajinagar, Maharashtra. The inspection, which took place from November 24-28, concluded with zero Form 483 observations, indicating that the facility met all the necessary regulatory requirements.
This development is a significant milestone for the company, particularly in light of the recent inspection of its formulations manufacturing facility in North Carolina, USA. The U.S. FDA had inspected the Monroe site from June 9-17 and issued a Form-483 with five observations, resulting in a warning letter being issued in June 2023. However, following corrective actions, the facility has now received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status, allowing commercial manufacturing to restart.
The successful inspection of the Chhatrapati Sambhajinagar facility and the resolution of the issues at the North Carolina site demonstrate Glenmark Pharmaceuticals’ commitment to meeting the highest standards of quality and regulatory compliance. The company’s ability to address the FDA’s concerns and achieve a favorable outcome is a testament to its capabilities and dedication to delivering high-quality products to patients.
The completion of the inspection with zero Form 483 observations is a notable achievement, as it indicates that the facility has met all the necessary regulatory requirements without any major deficiencies. This outcome is likely to enhance the company’s reputation and credibility in the pharmaceutical industry, both in India and globally. With the restart of commercial manufacturing at the Monroe site, Glenmark Pharmaceuticals is poised to continue delivering its products to patients in the U.S. market, while also maintaining its commitment to quality and regulatory compliance. Overall, this development is a positive step forward for the company, and it is likely to have a favorable impact on its business operations and reputation.
China’s NMPA grants approval to products from Zydus and Glenmark.
Zydus Lifesciences and Glenmark Pharmaceuticals have both received approvals from China’s National Medical Products Administration (NMPA) for their respective products. Zydus Lifesciences has been granted approval for Venlafaxine Extended-Release (ER) Capsules, 75 mg and 150 mg, which is the company’s first approval from the NMPA. The product will be manufactured at Zydus’ facility in Ahmedabad and is used to treat various conditions including Major Depressive Disorder, Generalised Anxiety Disorder, Social Anxiety Disorder, and Panic Disorder.
Glenmark Pharmaceuticals, on the other hand, has received approval for its Ryaltris compound nasal spray (GSP 301 NS) for the treatment of allergic rhinitis (AR) in adults and children. This approval is a significant milestone in Glenmark’s respiratory pipeline and was granted without any additional requests for supplementation. The commercialization of Ryaltris in China will be undertaken by Grand Pharmaceuticals Group under an exclusive licensing agreement.
The approval of these products is a significant development for both companies, as China is a key market for pharmaceutical companies. Glenmark Pharmaceuticals has stated that China is a priority market for the company, and they are committed to making their treatment accessible to patients and healthcare professionals in the country. The partnership with Grand Pharmaceuticals Group will enable Glenmark to achieve this goal.
The approvals are also a testament to the quality and efficacy of the products developed by Zydus Lifesciences and Glenmark Pharmaceuticals. The NMPA is a stringent regulatory authority, and the approval of these products demonstrates the companies’ ability to meet the highest standards of quality and safety. Overall, these approvals are a positive development for both companies and are expected to have a significant impact on their business in the Chinese market.
Glenmark Aquatic Foundation and Leander Paes’ Samanta Sports Academy Join Hands with KIIT and KISS to Boost Sports Development – orissadiary.com
The Leander Paes-Samanta Sports Academy has partnered with the Glenmark Aquatic Foundation to promote sports development at Kalinga Institute of Industrial Technology (KIIT) and Kalinga Institute of Social Sciences (KISS) in Bhubaneswar, Odisha. This collaboration aims to provide world-class training and infrastructure to aspiring athletes, particularly in the disciplines of tennis and swimming.
The partnership will enable the creation of a state-of-the-art tennis academy at KIIT, which will be equipped with modern facilities and coached by experienced professionals. Leander Paes, the Indian tennis legend, will be closely involved in the development of the academy and will provide guidance and mentorship to young tennis players. The academy will offer training programs, workshops, and competitions to identify and nurture talent from across the region.
In addition to tennis, the partnership will also focus on promoting swimming as a sport at KISS. The Glenmark Aquatic Foundation will work with KISS to establish a swimming program, which will provide training and coaching to students. The program will be designed to promote swimming as a sport and provide opportunities for young swimmers to compete at the national and international levels.
The collaboration between the Leander Paes-Samanta Sports Academy and the Glenmark Aquatic Foundation is expected to have a significant impact on the development of sports in Odisha. The partnership will not only provide opportunities for young athletes to develop their skills but also promote a culture of sportsmanship and healthy competition.
Dr. Achyuta Samanta, the founder of KIIT and KISS, expressed his enthusiasm for the partnership, stating that it will provide a platform for young athletes to pursue their passion for sports and achieve excellence. He also acknowledged the importance of sports in promoting education, health, and overall development.
The partnership is also expected to contribute to the growth of sports infrastructure in Odisha, which has been a key focus area for the state government. The collaboration will help to create world-class facilities and provide opportunities for athletes to train and compete at the highest levels.
Overall, the partnership between the Leander Paes-Samanta Sports Academy and the Glenmark Aquatic Foundation is a significant development for sports in Odisha, and is expected to have a lasting impact on the growth and development of tennis and swimming in the region. With the support of experienced professionals and world-class infrastructure, young athletes from Odisha will have the opportunity to pursue their dreams and achieve excellence in their chosen sports.
Glenmark Pharmaceuticals Inc., USA will introduce Ropivacaine Hydrochloride Injection USP in three concentrations: 2mg/mL, 5mg/mL, and 10mg/mL, available in 20mL and 30mL single-dose vials.
Glenmark Pharmaceuticals Inc., USA, has announced the upcoming launch of Ropivacaine Hydrochloride Injection USP, a generic version of Naropin Injection, in November 2025. The new product will be available in three strengths: 40 mg/20 mL (2mg/mL), 150 mg/30 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL) Single-Dose Vials. According to IQVIA sales data, the Naropin Injection market achieved annual sales of approximately $20.9 million for the 12-month period ending August 2025.
Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to Naropin Injection, making it a quality and affordable alternative for patients. The launch of this product represents another important addition to Glenmark’s expanding injectable portfolio, reinforcing the company’s dedication to providing quality and affordable alternatives to market for patients in need.
Marc Kikuchi, President & Business Head, North America, commented on the launch, stating that the company is pleased to announce the launch of Ropivacaine Hydrochloride Injection USP. Glenmark’s product is only approved for the indications listed in the company’s approved label, which may not include all the indications for the reference listed drug, Naropin Injection.
Glenmark Pharmaceuticals Ltd. is a research-led, global pharmaceutical company with a presence across Branded, Generics, and OTC segments, focusing on therapeutic areas such as respiratory, dermatology, and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark has been recognized as one of the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023 and one of the Top 50 Generics and biosimilar companies ranked by sales in 2024.
The company has also made a commitment to reduce its Green House Gas (GHG) emission, with targets approved by the Science Based Target initiative (SBTi) in 2023. Glenmark’s CSR interventions have impacted over 3.3 million lives over the last decade. The company can be found on LinkedIn and Instagram, and more information is available on their website, www.glenmarkpharma.com.