The company has a robust global footprint, with significant operations in the US (37% of global revenues, $891 million enterprise), Europe, Japan, Australia, and emerging markets like India, Brazil, Mexico, and South Africa. Its US subsidiary, Lupin Pharmaceuticals Inc., is the 4th largest generic player by prescriptions, leading in 46 of 140 marketed products. Lupin operates 15 state-of-the-art manufacturing facilities across India, the US, Brazil, and Mexico, and invests heavily in R&D, focusing on complex generics, biosimilars, and specialty drugs like inhalation and injectables. Strategic acquisitions, such as Medisol (France, 2023), Medquímica (Brazil, 2015), and Gavis/Novel (US, 2015), have bolstered its global reach and portfolio.
Lupin’s India business, contributing 34% of revenue, outperforms the market with a 3.4% share, driven by chronic therapies. The company emphasizes digital transformation, leveraging AI for innovation, and maintains a strong ESG framework. Despite challenges like regulatory hurdles (e.g., FDA warnings) and pricing pressures, Lupin has achieved double-digit growth, supported by a deep pipeline (154 ANDA filings pending FDA approval) and patient-centric initiatives like NovaShakti and Jeet. However, recent setbacks, such as the Myrbetriq patent litigation loss in 2025, pose risks. Lupin’s focus on innovation, affordability, and strategic expansion positions it for sustained growth in the global pharma landscape.
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Empowering Women’s Wellbeing: The Significance of Investing in Female Health on International Day of Action – lupin.com
The International Day of Action for Women’s Health is observed on May 28th every year to raise awareness about the importance of women’s health and well-being. Investing in women’s health is crucial for several reasons. Women play a vital role in the social and economic development of a country, and their health has a significant impact on the overall well-being of their families and communities.
Despite this, women’s health remains a neglected area, with many women facing barriers in accessing healthcare services, particularly in low- and middle-income countries. According to the World Health Organization (WHO), women are more likely to experience poverty, unemployment, and lack of education, which can limit their access to healthcare services. Additionally, women are often expected to prioritize the health and well-being of their families over their own, leading to neglect of their own health needs.
Investing in women’s health is important for several reasons. Firstly, it can lead to significant economic benefits. When women are healthy, they are more productive, and their participation in the workforce increases, contributing to the overall economic growth of a country. Secondly, investing in women’s health can lead to improved health outcomes for their families and communities. Healthy women are better equipped to care for their children, and their health has a positive impact on the overall well-being of their families.
Moreover, investing in women’s health can help address the significant disparities in healthcare that exist between men and women. Women are more likely to experience certain health conditions, such as cervical cancer, breast cancer, and maternal mortality, which can be prevented or treated with access to quality healthcare services. Furthermore, investing in women’s health can help promote gender equality and empower women to make informed decisions about their health and well-being.
To achieve this, governments, healthcare providers, and individuals must work together to address the barriers that women face in accessing healthcare services. This can be achieved by increasing access to affordable and quality healthcare services, promoting education and awareness about women’s health, and supporting policies that promote gender equality and women’s empowerment.
In conclusion, investing in women’s health is crucial for promoting the well-being of women, their families, and communities. It can lead to significant economic benefits, improved health outcomes, and promote gender equality. On this International Day of Action for Women’s Health, we must renew our commitment to prioritizing women’s health and well-being, and work together to address the barriers that women face in accessing healthcare services. By doing so, we can create a healthier, more equitable, and prosperous world for all.
Lupin and Honeywell Collaborate to Develop Eco-Friendly Inhaler Solutions with Innovative Propellant Technology.
Lupin Limited, a leading pharmaceutical company, has partnered with Honeywell to integrate the Solstice Air propellant into its next-generation inhalers for respiratory care. This collaboration aims to enhance treatment for patients with asthma and chronic obstructive pulmonary disease (COPD) while reducing the environmental impact of inhaler technologies. Solstice Air is a non-flammable propellant that offers a more environmentally friendly alternative to traditional hydrofluorocarbon (HFC)-based options, decreasing greenhouse gas emissions by up to 99.9%.
Lupin plans to become the first pharmaceutical company in India to use Solstice Air as a large-scale propellant in pressurized metered-dose inhalers (pMDIs). This move aligns with the company’s commitment to minimizing its carbon footprint while delivering effective care to patients. Vinita Gupta, CEO of Lupin, emphasized the company’s dedication to providing high-quality treatments while ensuring a healthier and more sustainable future for patients and communities globally.
The partnership with Honeywell reflects Lupin’s focus on advancing sustainable healthcare solutions. Ashish Modi, President of Honeywell India, highlighted the importance of Solstice Air in delivering safe and effective treatments while minimizing harmful greenhouse gas emissions. The companies are currently negotiating the details of the partnership, with the goal of finalizing the terms soon.
Lupin Limited is a major player in the global pharmaceutical industry, with a strong presence in therapy areas such as respiratory care, cardiovascular, and anti-diabetic treatments. The company operates 15 manufacturing facilities and seven research centers globally, employing over 23,000 professionals. Honeywell, a global leader in technology and innovation, is committed to addressing complex challenges through its cutting-edge solutions, enhancing safety, security, and sustainability worldwide.
The integration of Solstice Air into Lupin’s inhalers is expected to significantly reduce the environmental impact of respiratory treatments. With this partnership, Lupin and Honeywell are taking a major step towards advancing sustainable healthcare solutions and reducing carbon emissions. The collaboration demonstrates the companies’ shared commitment to providing effective treatments while promoting environmentally responsible practices. By adopting innovative technologies like Solstice Air, Lupin is poised to make a positive impact on the environment and improve patient health outcomes.
Lupin CEO Discusses Impact of Trump’s Most Favored Nation Policy and Tariffs on Company’s Five-Year Strategy
Lupin’s CEO Vinita Gupta and Managing Director Nilesh Gupta recently addressed investors, discussing the company’s strategic plans and the impact of US policies on the pharmaceutical industry. As a major market for Lupin, the US is a significant focus area for the company. Vinita Gupta shared her insights on the Trump administration’s Most Favored Nation (MFN) policy, which aims to reduce drug prices by linking them to the lowest price paid by other developed countries.
Gupta expressed concerns that the MFN policy could have unintended consequences, such as reducing competition and limiting patient access to affordable medicines. She emphasized the need for a more nuanced approach to addressing drug pricing, one that balances affordability with the need to incentivize innovation. The company is closely monitoring the situation and engaging with stakeholders to ensure that patient interests are protected.
The Guptas also discussed the Inflation Reduction Act (IRA), which imposes a “pill penalty” on pharmaceutical companies that raise prices above inflation. While the intent of the policy is to control prices, Lupin’s leadership believes it may have a disproportionate impact on generic drug manufacturers like themselves. The penalty could limit their ability to invest in research and development, potentially stifling innovation in the generic space.
Despite these challenges, Lupin remains committed to its strategic plan, which focuses on complex generics and technology platforms. The company aims to launch a range of complex products, including biosimilars and injectables, over the next five years. To support this effort, Lupin is investing in digital transformation and leveraging technology to enhance its manufacturing capabilities and supply chain efficiency.
Nilesh Gupta outlined the company’s five-year roadmap, which emphasizes the development of complex generics and niche products. He highlighted the potential for these products to drive growth and profitability, while also expanding access to affordable medicines for patients. The company is also exploring opportunities in emerging markets, where there is a growing demand for high-quality, affordable healthcare products.
Overall, Lupin’s leadership is confident in the company’s ability to navigate the evolving US regulatory landscape and capitalize on emerging opportunities. With a focus on complex generics, technology platforms, and strategic investments, Lupin is well-positioned to achieve its growth objectives and deliver value to patients, customers, and shareholders. As the company embarks on its five-year plan, it remains committed to its mission of making healthcare more accessible and affordable for people around the world.
The Indian market for active pharmaceutical ingredients has experienced significant revenue generation.
The India Active Pharmaceutical Ingredients (API) market is expected to experience significant growth, with an estimated value of USD 14.81 billion in 2025 and a projected value of USD 25.23 billion by 2032, at a compound annual growth rate (CAGR) of 7.9%. This growth is driven by increasing demand for pharmaceuticals, innovation, and the presence of key players in the market.
The report provides a comprehensive analysis of the India Active Pharmaceutical Ingredients market, including market size, revenue, production, and CAGR. It also highlights the competitive landscape, with key players such as Dr. Reddy’s Laboratories, Aurobindo Pharma, Lupin, Cipla, and Sun Pharmaceutical Industries. The report provides a detailed review of major players, covering their financials, product benchmarking, and competitive strategies.
The market is segmented by manufacturer, synthesis type, drug type, application, product type, and formulation. The report also analyzes the geographical landscape of the market, with a focus on North America, Europe, Asia-Pacific, South America, and the Middle East & Africa.
The report identifies key drivers and trends in the market, including technological advancements, regulatory and policy shifts, and emerging industry trends. It also highlights the opportunities and challenges in the market, including supply chain issues and evolving consumer behavior.
The report provides actionable insights and quantitative analysis of market segments, trends, estimations, and dynamics. It also includes Porter’s Five Forces analysis for strategic decision-making and segmentation analysis to identify market opportunities.
The key benefits of the report include:
* Quantitative analysis of market segments, trends, estimations, and dynamics
* Insights into key drivers, restraints, and opportunities
* Porter’s Five Forces analysis for strategic decision-making
* Segmentation analysis to identify market opportunities
* Revenue mapping of major countries by region
* Benchmarking and positioning of market players
* Analysis of regional and global trends, key players, and growth strategies
The report is a valuable resource for industry leaders, investors, and decision-makers, providing a comprehensive and detailed analysis of the India Active Pharmaceutical Ingredients market. It is available for purchase, with a 25% discount for a limited time.
USFDA grants approval to Lupin for generic kidney disease medication, as reported by Rediff Moneynews.
Lupin Ltd, a leading pharmaceutical company, has received approval from the US Food and Drug Administration (USFDA) for its generic version of Tolvaptan tablets. The tablets are indicated for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a certain type of kidney disease. The approval is for Tolvaptan tablets in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg, which are bioequivalent to Jynarque tablets manufactured by Otsuka Pharmaceutical Company Ltd.
Lupin is the exclusive first-to-file for this product, making it eligible for 180 days of generic drug exclusivity. This means that Lupin will be the only company allowed to manufacture and market the generic version of Tolvaptan tablets in the US for the next 180 days. The company plans to manufacture the product at its Nagpur facility and will launch it soon.
The approval marks a significant entry into the nephrology segment for Lupin, demonstrating its commitment to addressing the unmet needs of patients globally. Tolvaptan is used to slow kidney function decline in adults at risk of rapidly progressing ADPKD. The treatment had an estimated annual sale of USD 1,467 million in the US in 2024, indicating a significant market opportunity for Lupin.
According to Lupin CEO Vinita Gupta, the approval is a significant milestone for the company. “This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally,” she said. The approval is also a testament to Lupin’s capabilities in developing and manufacturing complex generic products.
The USFDA approval is a major win for Lupin, and the company is expected to capitalize on the exclusivity period to establish itself as a major player in the nephrology segment. With the launch of the generic version of Tolvaptan tablets, Lupin aims to provide an affordable treatment option for patients with ADPKD, improving access to healthcare and making a positive impact on the lives of patients globally.
Stock Market Updates for Lupin
Recent Updates
A recent study showcases the impressive real-world effectiveness and safety of Lupin’s ranibizumab biosimilar, Ranieyes.
The BRESER study, conducted by Lupin, has successfully demonstrated the real-world efficacy and safety of their ranibizumab biosimilar, Ranieyes. The study was conducted in collaboration with various medical institutions and evaluated the use of Ranieyes in a diverse patient population. The results showed that Ranieyes was effective in treating various retinal disorders, including age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion.
The study’s primary endpoint was to assess the efficacy of Ranieyes in reducing the risk of vision loss and improving visual acuity in patients with these conditions. The results showed that Ranieyes was able to achieve these goals, with a significant reduction in the risk of vision loss and a significant improvement in visual acuity.
In addition to its efficacy, the study also evaluated the safety of Ranieyes. The results showed that Ranieyes was well-tolerated, with a low incidence of adverse events. The most common side effects reported were typically mild and temporary, such as conjunctival hemorrhage, conjunctival injection, and eye fatigue.
The BRESER study is significant because it provides real-world evidence of the efficacy and safety of Ranieyes in a diverse patient population. This type of evidence is critical for patients and healthcare providers, as it provides a more comprehensive understanding of how a treatment performs in real-world settings.
The results of the BRESER study are also relevant to the ongoing debate about the use of biosimilars in healthcare. Biosimilars are often seen as a lower-cost alternative to branded biological products, but some have raised concerns about their safety and efficacy. The BRESER study helps to address these concerns by providing real-world evidence of the efficacy and safety of Ranieyes.
In conclusion, the BRESER study demonstrates the real-world efficacy and safety of Lupin’s ranibizumab biosimilar, Ranieyes. The study’s results show that Ranieyes is effective in treating various retinal disorders, and is well-tolerated with a low incidence of adverse events. The study provides important real-world evidence that can be used to inform treatment decisions and address concerns about the use of biosimilars in healthcare.
Lupin is expanding its healthcare offerings beyond traditional pharmaceuticals by investing in digital therapeutics.
Lupin Digital Health, a subsidiary of pharmaceutical company Lupin, is expanding its digital therapeutics platform to focus on cardiac care. The platform, known as Lyfe, uses real-time monitoring to track patients’ vitals, activity, and clinical goals, as well as connects patients with doctors and carers. The company’s chief executive, Sidharth Srinivasan, aims to offer personalized care to patients with cardio-metabolic illnesses.
Lupin Digital Health is growing rapidly, with a current patient base of around 10,000 individuals. The company expects to reach 50,000 patients by the end of the year and 2-3 lakh patients by the end of the fiscal year. The platform is being used for various purposes, including post-surgery rehabilitation and prevention programs for at-risk individuals.
The company is also expanding its offerings beyond medicines, with an aggressive push into digital therapeutics. Lupin Digital Health’s growth is not limited to its patient base; its revenue has more than doubled, driven by an increase in average selling price and a shift towards full-year packs.
Lupin Digital Health is partnering with larger hospitals and insurers to expand its reach. The company has partnered with the top five insurers and around 40-50 hospitals across the country, and plans to announce another 40-50 hospital partnerships in the next two months.
The platform is seeing increasing interest from insurers, who are developing specific cardiac care plans for policyholders. Lupin Digital Health’s Lyfe platform could be onboarded to these plans, making it a win-win for both the company and the insurers.
The company is also launching an AI-led cardiac risk prevention product as a D2C offering soon. This product will be a proprietary solution that can be used by anyone, not just patients with existing cardiac conditions.
Overall, Lupin Digital Health is poised for significant growth and expansion in the digital therapeutics space. Its focus on cardiac care and preventive measures is expected to drive growth, as well as its partnerships with hospitals and insurers.
Lupin Strengthens UK Footprint with Strategic Acquisition of Renascience
Lupin Healthcare (UK) Limited, a subsidiary of global pharmaceutical company Lupin Limited, has acquired Renascience Pharma Limited, a UK-based pharmaceutical company specializing in four key specialty products. The acquisition strengthens Lupin’s position in the UK’s branded pharmaceutical market and expands its portfolio to better serve patients and healthcare providers. Renascience brings a strong portfolio of specialty medicines, including branded injectable cephalosporins for infectious diseases, a topical treatment for ear pain, and a branded quinazoline-like diuretic for cardiovascular and renal conditions.
With the acquisition, Lupin gains complete ownership of Renascience and will operate it as its subsidiary. The company will integrate Renascience’s products into its existing lineup, enhancing its ability to provide critical medications to patients across the UK. Lupin’s President of Corporate Development, Fabrice Egros, emphasized the importance of the acquisition in expanding the company’s branded medicine portfolio and addressing unmet medical needs.
Eric Che, Co-founder and Director of Renascience, expressed pride in the company’s impact and its commitment to improving patient access to specialty and critical medicines. He praised Lupin’s culture, expertise, and capabilities as the perfect fit to take Renascience to the next stage of growth.
The acquisition is expected to advance patient care in the UK by enhancing treatment options and improving patient outcomes. Lupin aims to leverage Renascience’s expertise and product lineup to support the National Health Service (NHS) in delivering efficient and sustainable healthcare services. Overall, the acquisition demonstrates Lupin’s commitment to delivering high-quality, innovative healthcare solutions and its continued growth in the UK pharmaceutical market.
A sudden surge in demand for Doxorubicin may send market momentum soaring, with influential companies like Merck & Co., Lupin, and Cipla playing a pivotal role.
The latest survey on the Doxorubicin market has been conducted to provide a comprehensive analysis of the market’s performance, competitive environment, and market size. The report covers the period from 2019 to 2024 and provides a forecast till 2031. The market size is estimated to be around USD 2.3 million in 2024 and is expected to grow at a CAGR of 5.5% to reach USD 3.4 million by 2031.
The report profiles key and emerging players in the Doxorubicin market, including Johnson & Johnson Services, Inc., Sun Pharmaceutical Industries Ltd., Merck & Co., Inc., Cipla Inc., Lupin, Cadila Pharmaceuticals, SRS Life Sciences, and Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co., Ltd. The report also provides a detailed analysis of the market segments, including Lyophilized Powder and Doxorubicin Injection, as well as applications such as Bladder Cancer, Kaposi Sarcoma, Leukemia, Lymphoma, Breast Cancer, and Other.
The report highlights the key drivers and challenges in the market, including increasing cancer prevalence, advancements in drug delivery systems, and rising demand for chemotherapy drugs. However, it also notes the challenges associated with resistance to chemotherapy, side effects, high treatment costs, and the need for better drug delivery methods.
The report also provides insights into the market leaders’ and development strategies, including the acquisition of Apexigen by Pyxis Oncology for $16 million. This acquisition positions Pyxis Oncology at the forefront of antibody-drug conjugate (ADC) innovation and expands its clinical pipeline into phase 2 in select solid tumor types.
The report is available in multiple formats, including a standard version, a premium version, and a customized version. The standard version of the report covers the main market segments, while the premium version provides additional insights into macroeconomic factors, inflationary cycles, and the impact of the Russia-Ukraine war on the value and supply chain. The customized version of the report can be tailored to meet the specific needs of the buyer.
Overall, the report provides a comprehensive analysis of the Doxorubicin market, highlighting its key drivers and challenges, as well as the strategies and developments of key market leaders. It is a valuable resource for companies, investors, and researchers seeking to understand the market’s performance and growth potential.
Two of Lupin’s most senior executives will be stepping down in just 48 hours’ time.
According to recent reports, three senior executives at Lupin, a major Indian pharmaceutical company, have decided to retire in just two days. The news has sent shockwaves through the industry, with many speculating about the reasons behind their sudden departure.
Lupin is a well-known player in the global pharmaceutical market, with a significant presence in over 75 countries. The company has a range of products across various therapeutic areas, including cardiovascular, gastrointestinal, respiratory, and anti-infective medications.
The retiring executives are said to be from the company’s top management tier, with expertise in various areas, including operations, research and development, and commercialization. Their departure is expected to have a significant impact on the company’s leadership and direction, as well as its ability to execute its current strategies.
The sudden and unexpected retirement of the three executives has left many wondering about the reasons behind their decision. Some have speculated about potential disagreements with the company’s leadership or differences in vision, while others have pointed to the high-stress and demanding nature of the pharmaceutical industry.
In a statement, Lupin confirmed the news, saying that the retiring executives “have played a significant role in the company’s growth and evolution” and that “their contributions will be deeply missed.” However, the statement did not provide further details on the reasons behind their retirement.
The departure of the three senior executives is expected to have significant implications for Lupin’s future, including the identification of new leaders to fill the void. With the pharmaceutical industry facing numerous challenges, including intense competition, regulatory hurdles, and increasing demands for innovation, Lupin’s ability to adapt and evolve will be crucial to its continued success.
Overall, the sudden retirement of three senior executives at Lupin comes as a surprise, and their departure is likely to send shockwaves through the industry. As the company looks to the future, it will be important to identify new leaders who can build on the legacy of their predecessors and drive the business forward in an increasingly complex and competitive environment.
Eli Lilly expands its global footprint by introducing Mounjaro, a groundbreaking weight management medication, to the Indian market.
Eli Lilly & Co. has launched its anti-obesity drug Mounjaro in India, making it the country’s first treatment of its kind. The drug, which is used to treat obesity and type-2 diabetes, works by activating hormones that help reduce the amount of sugar in the blood and slow digestion. Mounjaro is priced at ₹3,500 to ₹4,375 per month, depending on the dosage.
The company has faced competition from other foreign pharma companies, with plans to introduce similar products in the growing market. However, Mounjaro’s unique pricing strategy, which is expected to be around 14,000-17,500 per month, makes it an attractive option for Indian patients.
The demand for GLP-1 drugs, which help reduce weight, has boomed, with the market expected to reach $100 billion by 2030. However, rival semaglutide (Ozempic) goes off-patent in 2026, and generics makers like Cipla, Dr Reddy’s, Lupin, Natco Pharma, Mankind Pharma, and Biocon are gearing up to launch cheaper generic copies.
Despite this, experts expect Mounjaro to be a hit in India, given the high demand for weight loss drugs. According to a senior diabetologist, a significant percentage of his patients are overweight, and the use of Mounjaro could lead to a 15-20% pickup in patients with type-2 diabetes.
In addition, the growing number of people with obesity in India, from 180 million in 2021 to 450 million by 2050, could lead to increased demand for weight loss drugs like Mounjaro. The market for GLP-1 drugs for patients with diabetes in India has already doubled to $3.6 billion in 2024, driven by unauthorized use of drugs like Ozempic and Mounjaro through the grey market.
Lupin earns Silver Medal for EcoVadis’ sustainability excellence awards
Lupin, a global pharmaceutical company, has been awarded the EcoVadis Silver Medal for sustainability excellence. The award recognizes Lupin’s commitment to sustainability across its entire value chain, from sourcing and production to distribution and end-of-life environmental management.
EcoVadis is a leading platform for sustainability ratings and performance improvement, providing a comprehensive assessment of companies’ environmental, social, and governance (ESG) performance. The Silver Medal is the second-highest award offered by EcoVadis, indicating that Lupin has demonstrated a strong track record of sustainability performance over the past year.
Lupin’s sustainability efforts focus on six key areas: environment, social, governance (ESG), value chain engagement, community development, and stakeholder engagement. The company has made significant progress in reducing its environmental impact, including a 25% reduction in energy consumption and a 30% decrease in greenhouse gas emissions since 2015.
In addition, Lupin has implemented various social initiatives, such as employee engagement programs, diversity and inclusion initiatives, and community development projects. The company has also strengthened its governance structure, ensuring transparency and accountability in its decision-making processes.
The award is a testament to Lupin’s commitment to sustainability and its efforts to create a positive impact on the environment, society, and its stakeholders. The company plans to continue its sustainability journey, exploring new opportunities for growth while minimizing its environmental footprint and promoting positive social change.
The EcoVadis Silver Medal is a milestone achievement for Lupin, demonstrating its leadership in the pharmaceutical industry. The award also reinforces the company’s commitment to transparency, accountability, and continuous improvement. With this recognition, Lupin aims to inspire other organizations to follow its lead in embracing sustainability as a key business strategy.
Lupin gains provisional clearance from the US FDA for its Amifampridine Tablets
Lupin Limited, a pharmaceutical company, has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Amifampridine Tablets, 10mg. This product is indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older. The drug is a generic version of Firdapse Tablets, 10mg, which has an estimated global net sale of $306 million for the fiscal year ended December 31, 2024.
The product will be manufactured at Lupin’s Goa facility in India, making it a significant milestone for the company. The tentative approval is a crucial step towards making the drug available to patients at an affordable price, as it allows the company to market and sell the product in the US market. The drug is expected to be a major contributor to the company’s revenue, given its high estimated global net sales.
Lambert-Eaton myasthenic syndrome is a rare autoimmune disorder that affects the nervous system and can cause muscle weakness and paralysis. The condition can significantly impact daily life, making it essential to have effective treatment options available. With this approval, Lupin’s Amifampridine Tablets, 10mg, is set to provide a cost-effective alternative to existing treatment options, thereby improving patient access to the medication.
The approval is a testament to Lupin’s commitment to providing high-quality and affordable generic medicines to patients worldwide. The company’s Goa facility has a reputation for producing high-quality products, and this approval is a reflection of the facility’s capabilities. Overall, this approval is a significant achievement for Lupin, and the company is expected to benefit significantly from the sale of this product in the US market.
Novartis’ Lupin expands its US presence with FDA approval of Amifampridine, strengthening its portfolio of treatments for patients in the US.
The US Food and Drug Administration (USFDA) has granted tentative approval to Lupin Ltd’s Abbreviated New Drug Application (ANDA) for Amifampridine Tablets, 10 mg, for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune neuromuscular disorder that affects communication between nerve and muscle. This approval allows Lupin to enter the market and offers a major market opportunity, as the reference drug Firdapse had global net sales of $306 million in 2024. The tablets will be manufactured at Lupin’s facility in Goa, boosting the company’s global manufacturing capabilities and commitment to providing affordable medications.
While the tentative approval meets all quality, safety, and efficacy requirements, final approval will depend on the expiration of or resolution of patent or exclusivity rights related to Firdapse. This approval aligns with Lupin’s focus on developing and expanding its presence in the US market. The successful launch of Amifampridine Tablets, 10 mg, will allow Lupin to capitalize on the large market for LEMS treatment, providing a major boost to its business and financials. With this approval, Lupin reinforces its position as a leading player in the global pharmaceutical industry, committed to delivering high-quality, affordable medications to patients worldwide.
Novo Nordisk launches AjaDuo, a new fixed-dose combination of empagliflozin and linagliptin, at an affordable price.
Lupin, a leading pharmaceutical company, has announced the launch of AjaDuo, a fixed-dose combination (FDC) of empagliflozin and linagliptin, at an affordable price. The launch is a significant development in the Indian pharmaceutical market, offering patients with type 2 diabetes a new and cost-effective treatment option.
AjaDuo is a combination therapy that combines the benefits of two medications: empagliflozin, an SGLT-2 inhibitor, and linagliptin, a DPP-4 inhibitor. This combination has been shown to improve glycemic control and reduce blood sugar levels. The fixed-dose combination is expected to offer benefits such as improved patient adherence, reduced pill burden, and enhanced convenience.
Lupin’s AjaDuo is priced competitively, making it an attractive option for patients with type 2 diabetes who require combination therapy. The company’s efforts to launch affordable medications are aimed at increasing access to quality healthcare, particularly in developing countries like India where healthcare infrastructure is often limited.
The launch of AjaDuo is a strategic move by Lupin to expand its presence in the diabetes market, which is one of the fastest-growing therapeutic segments globally. The company’s portfolio already includes several popular diabetes drugs, and the launch of AjaDuo is expected to further strengthen its position in this space.
The availability of AjaDuo at an affordable price is expected to benefit millions of patients with type 2 diabetes, who may not have access to branded treatments or may be forced to compromise on their treatment due to cost constraints. The launch is a significant step towards increasing access to quality healthcare for patients, especially in emerging markets.
Overall, the launch of AjaDuo by Lupin is a positive development in the Indian pharmaceutical market, offering patients with type 2 diabetes a new and affordable treatment option. The company’s initiatives to make high-quality medications accessible at affordable prices are likely to benefit millions of patients across the country.
This popular diabetes medication is set to get a significant price cut, dropping from Rs 60 to just Rs 9 per unit.
The cost of Empagliflozin, a crucial drug for managing diabetes and its associated conditions, is set to drop significantly in India. The price of the medicine, which was previously around Rs 60 per tablet, will be reduced to just Rs 9 per tablet, making it more accessible to millions of diabetes patients in the country. This development comes after the patent for the drug, which was previously held by German pharmaceutical company Boehringer Ingelheim, expired on March 11.
As a result, Indian pharmaceutical companies such as Mankind Pharma, Torrent, Alkem, Dr. Reddy, and Lupin will be able to introduce their own versions of the drug, offering patients cheaper alternatives. Mankind Pharma, for example, plans to offer the drug at a price 90% lower than the innovator company, making it more affordable for patients.
Empagliflozin plays a crucial role in preventing heart failure and delaying kidney failure, making it a vital medication for those with diabetes. However, its high cost has previously made it difficult for many to access. The introduction of more affordable options from Indian companies is expected to bring significant benefits to millions of patients.
The reduced price of Empagliflozin is poised to provide much-needed financial relief to diabetes patients, who often face the burden of out-of-pocket medication expenses. In India, over 10.1 crore people are living with diabetes, and limited insurance coverage often leaves patients to shoulder medication costs independently. The availability of more affordable options is expected to make a significant difference in the lives of these patients.
The economic burden of diabetes in India is substantial, and the reduced price of Empagliflozin is a welcome development for diabetic patients across the country. With the introduction of more affordable alternatives, millions of patients will have access to a vital medication, allowing them to better manage their condition and improve their overall health.