Lupin, a pharmaceutical company, has recently received the USFDA OAI (Official Action Indicated) status for its Pithampur Unit 2 facility. The USFDA (United States Food and Drug Administration) is responsible for ensuring the safety and efficacy of drugs and medical devices in the United States.

The OAI status indicates that the facility has undergone an inspection by the USFDA and has been found to have certain deficiencies that need to be addressed. However, it does not necessarily mean that the facility is non-compliant or that its products are unsafe. Rather, it is an opportunity for the company to take corrective action and improve its processes to meet the regulatory requirements.

The Pithampur Unit 2 facility is one of Lupin’s manufacturing sites, and it is used to produce a range of pharmaceutical products. The facility has undergone several inspections by regulatory agencies in the past, and this latest development is a significant step towards ensuring that the products manufactured at this site meet the highest standards of quality and safety.

Receiving the OAI status can have both positive and negative implications for Lupin. On the one hand, it provides an opportunity for the company to identify and address areas for improvement, which can ultimately lead to better quality products and increased customer satisfaction. On the other hand, it may also lead to delays in the approval of new products or the shipment of existing products, which can impact the company’s revenue and profitability.

It’s worth noting that the USFDA inspection process is rigorous and thorough, and the agency uses a risk-based approach to prioritize inspections. The fact that Lupin’s Pithampur Unit 2 facility has received the OAI status suggests that the USFDA has identified some areas that require attention, but it does not necessarily mean that the facility is non-compliant.

In conclusion, Lupin’s receipt of the USFDA OAI status for its Pithampur Unit 2 facility is an important development that highlights the company’s commitment to quality and safety. While it may present some challenges, it also provides an opportunity for the company to improve its processes and ensure that its products meet the highest standards of quality and safety. As a leading pharmaceutical company, Lupin is expected to take corrective action and address the deficiencies identified by the USFDA, and it is likely that the company will work closely with the agency to resolve any issues and ensure that its products continue to meet the regulatory requirements.

The OAI status is not a final determination, and the company will have the opportunity to respond to the USFDA’s findings and implement corrective actions. The USFDA will then re-inspect the facility to ensure that the necessary corrections have been made. Lupin’s ability to address the deficiencies and improve its processes will be critical in determining the outcome of the inspection and the future of its Pithampur Unit 2 facility.

Lupin, a pharmaceutical company, has announced the retirement of its Manufacturing Operations President, Rajendra Chunodkar. As a key member of the company’s leadership team, Chunodkar has played a crucial role in overseeing the manufacturing operations of the organization.

With his retirement, Lupin will be undergoing a change in its leadership structure. The company has not yet announced who will be replacing Chunodkar as the President of Manufacturing Operations. It is expected that the new leader will bring fresh perspectives and ideas to the role, and will be responsible for driving the company’s manufacturing strategy forward.

Chunodkar’s retirement marks the end of an era for Lupin, as he has been an integral part of the company’s growth and success. During his tenure, he has been instrumental in implementing various initiatives aimed at improving the efficiency and productivity of the company’s manufacturing operations. His expertise and experience have been invaluable to the organization, and he will be missed by his colleagues and peers.

The retirement of Chunodkar also presents an opportunity for Lupin to reassess its manufacturing operations and identify areas for improvement. The company may consider implementing new technologies, processes, and systems to enhance its manufacturing capabilities and stay competitive in the pharmaceutical industry.

As Lupin moves forward, it will be important for the company to maintain its focus on quality, innovation, and customer satisfaction. The company’s manufacturing operations are a critical component of its overall success, and it will be essential to ensure that the transition to new leadership is seamless and does not disrupt the company’s operations.

In recent years, Lupin has been expanding its global presence and diversifying its product portfolio. The company has also been investing in research and development, with a focus on developing new and innovative medicines. With a strong foundation in place, Lupin is well-positioned for continued growth and success in the pharmaceutical industry.

Overall, the retirement of Rajendra Chunodkar marks a significant change for Lupin, but the company is well-equipped to navigate this transition and continue to thrive in the pharmaceutical industry. As the company looks to the future, it will be important to build on the successes of the past while embracing new opportunities and challenges.

Lupin, a global pharmaceutical company, has recently announced a significant deal with VISUfarma, a European-based ophthalmic company, worth €190 million. This acquisition is expected to play a crucial role in Lupin’s strategy to de-risk its US business and bolster its specialty business segment.

The VISUfarma deal will enable Lupin to expand its presence in the European ophthalmic market, which is a high-growth area. VISUfarma has a strong portfolio of ophthalmic products, including prescription and over-the-counter (OTC) medications, which will complement Lupin’s existing offerings. The acquisition will also provide Lupin with access to VISUfarma’s manufacturing facilities and research and development (R&D) capabilities.

In terms of de-risking its US business, the VISUfarma deal will help Lupin reduce its dependence on the highly competitive and regulated US market. The US market has been a significant contributor to Lupin’s revenues, but it has also been a source of volatility due to factors such as pricing pressure and regulatory challenges. By expanding its presence in Europe through the VISUfarma acquisition, Lupin will be able to diversify its revenue streams and reduce its exposure to US market risks.

The VISUfarma deal will also boost Lupin’s specialty business segment, which is a key area of focus for the company. Lupin has been actively pursuing opportunities to expand its specialty business, which includes high-value, niche products that are less susceptible to competition from generic manufacturers. The VISUfarma acquisition will add a new dimension to Lupin’s specialty business, enabling the company to offer a wider range of ophthalmic products to customers in Europe and other markets.

Overall, the VISUfarma deal is a strategic move by Lupin to de-risk its US business, expand its presence in Europe, and bolster its specialty business segment. The acquisition is expected to contribute to Lupin’s long-term growth and profitability, and it demonstrates the company’s commitment to pursuing opportunities that align with its strategic objectives. With the VISUfarma deal, Lupin is well-positioned to navigate the challenges of the global pharmaceutical market and capitalize on emerging opportunities in the ophthalmic segment.

The U.S. Food and Drug Administration (FDA) recently conducted an inspection at Lupin’s biotech facility in Pune, India. The inspection, which took place from September 8-19, 2025, was a product-specific pre-approval inspection. As a result of the inspection, the FDA issued four observations to the company.

Lupin, a generic drugmaker, has stated that it will address the observations and respond to the FDA within the stipulated timeframe. The company made this announcement in a filing on September 20, 2025. While the specific details of the observations have not been disclosed, the fact that the FDA issued four observations indicates that there are some issues that need to be resolved before the facility can receive approval for the production of certain products.

The FDA’s inspection and subsequent observations are a standard part of the regulatory process for pharmaceutical companies. The agency’s primary concern is ensuring the safety and efficacy of drugs, and it conducts regular inspections to ensure that manufacturers are complying with regulations and guidelines.

Lupin’s biotech facility in Pune is one of the company’s key manufacturing sites, and the outcome of the FDA’s inspection could have significant implications for the company’s business. If the issues raised by the FDA are not addressed, it could potentially delay or prevent the approval of certain products, which could impact the company’s revenue and growth prospects.

However, it’s worth noting that receiving observations from the FDA is not uncommon, and many companies are able to address the issues raised and receive approval for their products. Lupin has stated that it will respond to the FDA’s observations, and it’s likely that the company will work to resolve the issues as quickly as possible. The company’s ability to address the FDA’s concerns and receive approval for its products will be closely watched by investors and industry analysts in the coming months. Overall, the FDA’s inspection and observations are an important part of the regulatory process, and Lupin’s response will be critical in determining the outcome for the company.

Lupin Ltd, a global pharmaceutical company, has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules. The approved capsules are available in strengths of 2.5 mg to 25 mg and are used to treat adult patients with Multiple Myeloma, a type of blood cancer, in combination with dexamethasone. The capsules will be manufactured at Lupin’s Pithampur facility in India.

This approval is significant, as the estimated annual sales of Lenalidomide Capsules in the United States are around $7,511 million. Lupin is a leading player in the pharmaceutical industry, with a strong presence in over 100 markets worldwide. The company specializes in a range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

With a dedicated workforce of over 24,000 personnel, Lupin has a strong position in both India and the US, excelling in multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company has 15 state-of-the-art manufacturing sites and seven research centers across the world, demonstrating its commitment to innovation and quality.

The approval of Lenalidomide Capsules is a testament to Lupin’s capabilities in developing and manufacturing complex generic products. The company’s strong research and development capabilities, combined with its global manufacturing footprint, enable it to bring high-quality products to patients worldwide. With this approval, Lupin is well-positioned to capitalize on the growing demand for generic pharmaceuticals in the US market.

Overall, the approval of Lenalidomide Capsules is a significant milestone for Lupin, demonstrating its ability to develop and manufacture complex generic products that meet the stringent regulatory standards of the US FDA. The company’s commitment to innovation, quality, and patient care is evident in its continued investments in research and development, manufacturing, and global expansion.

Lupin Ltd, a global pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules. The capsules, which will be manufactured at Lupin’s Pithampur facility in India, are indicated for the treatment of adult patients with multiple myeloma, transfusion-dependent anemia, and other related conditions. The FDA approval is a significant milestone for Lupin, as Lenalidomide Capsules had estimated annual sales of $7,511 million in the United States.

Lupin Ltd is a Mumbai-based company with a strong presence in over 100 markets worldwide. The company specializes in a range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has a significant presence in India and the US, with a focus on multiple therapy areas such as respiratory, cardiovascular, and women’s health.

The company has a robust infrastructure, with 15 state-of-the-art manufacturing sites and seven research centers globally. Lupin also has a dedicated workforce of over 24,000 professionals and several subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. This is not the first FDA approval for Lupin, as the company received approval for its generic ‘Minzoya’ tablets last year. The Minzoya tablets are used to prevent pregnancy and are a generic equivalent of Balcoltra tablets.

The FDA approval for Lenalidomide Capsules is a testament to Lupin’s commitment to providing high-quality and affordable pharmaceutical products to patients worldwide. The company’s Pithampur facility in India, where the capsules will be manufactured, is a key part of Lupin’s global manufacturing network. With this approval, Lupin is well-positioned to expand its presence in the US market and provide patients with access to affordable and effective treatments for multiple myeloma and other related conditions. Overall, the FDA approval is a significant achievement for Lupin and reflects the company’s ongoing efforts to develop and market high-quality pharmaceutical products.

Lupin, a pharmaceutical company, has received two observations from the US Food and Drug Administration (USFDA) for its Aurangabad facility. The observations were made during a recent inspection of the facility, which is located in Maharashtra, India.

The USFDA conducts regular inspections of pharmaceutical facilities to ensure compliance with current good manufacturing practices (cGMP) regulations. These regulations are in place to ensure the quality, safety, and efficacy of drugs manufactured for the US market. During an inspection, the USFDA may issue observations, also known as Form 483 observations, if it identifies any deviations from cGMP regulations.

The two observations issued to Lupin’s Aurangabad facility are related to specific aspects of its manufacturing operations. Although the exact nature of the observations has not been disclosed, they are likely related to issues such as equipment calibration, cleaning and sanitation, or documentation practices.

Receiving observations from the USFDA can have significant implications for a pharmaceutical company. If the observations are not addressed promptly and effectively, the company may face regulatory action, including a warning letter or even a import ban.

Lupin has stated that it is taking the observations seriously and is working to address the issues identified by the USFDA. The company has a robust corrective action plan in place, which includes corrective and preventive actions to ensure compliance with cGMP regulations. Lupin is committed to maintaining the highest standards of quality and compliance at all its facilities, including the Aurangabad facility.

The receipt of USFDA observations is not uncommon in the pharmaceutical industry, and many companies receive observations during inspections. What is important is how the company responds to the observations and takes corrective action to prevent similar issues from arising in the future.

In this case, Lupin’s prompt response and commitment to addressing the observations demonstrate its dedication to quality and compliance. The company will likely work closely with the USFDA to ensure that all issues are resolved and that its Aurangabad facility is compliant with cGMP regulations.

Overall, the receipt of USFDA observations for Lupin’s Aurangabad facility highlights the importance of maintaining high standards of quality and compliance in the pharmaceutical industry. By addressing the observations promptly and effectively, Lupin can ensure the continued quality and safety of its products and maintain its reputation as a trusted pharmaceutical company.

Lupin, a global pharmaceutical company, has announced the launch of Prucalopride tablets in the United States. Prucalopride is a serotonin receptor agonist used to treat chronic idiopathic constipation (CIC) in adults. The medication works by increasing the movement of stool through the intestines, helping to relieve symptoms of constipation such as infrequent bowel movements, hard or lumpy stools, and straining during bowel movements.

The launch of Prucalopride tablets in the U.S. marks a significant milestone for Lupin, as it expands the company’s presence in the gastroenterology market. Lupin’s Prucalopride tablets are available in 1mg and 2mg strengths, and are marketed under the brand name Motofen. The medication is approved by the U.S. Food and Drug Administration (FDA) for the treatment of CIC in adults.

Chronic idiopathic constipation is a common gastrointestinal disorder that affects millions of people in the United States. It is characterized by persistent Difficulty with bowel movements, and can have a significant impact on a person’s quality of life. Prucalopride has been shown to be effective in treating CIC, with clinical trials demonstrating significant improvements in bowel movement frequency and consistency.

The launch of Prucalopride tablets in the U.S. is a significant addition to the treatment options available for CIC patients. Lupin’s Motofen is a convenient and effective treatment option that can help patients manage their symptoms and improve their overall quality of life. The medication is available by prescription only, and patients should consult with their healthcare provider to determine the best course of treatment for their individual needs.

Lupin’s launch of Prucalopride tablets in the U.S. is part of the company’s ongoing commitment to expanding its portfolio of specialty medications. The company has a strong focus on developing and commercializing medications that address significant unmet medical needs, and the launch of Motofen is an important step forward in this effort.

A private equity consortium led by PAG, an Asia-focused investment firm, has announced the appointment of Santosh Kumar Mahil as the Managing Director and CEO of Sekhmet Pharmaventures Pvt Ltd. Mahil replaces Anil Khubchandani, who was appointed to the role in 2023. With nearly three decades of experience in the pharmaceutical industry, Mahil brings a wealth of knowledge and expertise to his new role.

Mahil’s experience spans the entire pharmaceutical value chain, including active pharmaceutical ingredients (APIs), formulations, intermediates, and contract development and manufacturing (CDMO) services. He has held leadership roles at several prominent pharmaceutical companies, including Lupin, USV, Unichem, and Shilpa Medicare. In his most recent role, he served as CEO of Shilpa Pharma Life Sciences, an R&D and manufacturing subsidiary of Shilpa Medicare.

Sekhmet Pharmaventures is an investment platform established to support the next generation of API companies. It is the India arm of Gamot API Pte Ltd, a Singapore-based platform launched by PAG, along with Indian private equity firms CX Partners and Samara Capital. Sekhmet’s platform includes Chennai-based Anjan Drug Pvt Ltd and the Optimus Drugs Group of Companies, both of which are API manufacturers that emphasize global standards of quality and regulatory compliance.

As of March 2024, Sekhmet Pharma reported net sales of Rs 1,035 crore, a slight increase from Rs 1,004 crore in the previous year. The company’s net loss narrowed to Rs 190 crore from Rs 256 crore in March 2023. The appointment of Mahil as CEO is expected to help drive growth and expansion at Sekhmet Pharmaventures. His experience and expertise in the pharmaceutical industry will be invaluable in leading the company’s efforts to support the next generation of API companies.

The appointment of Mahil also follows the elevation of Nikhil Srivastava, partner and India head of PE at PAG, to co-head of the firm’s global PE business. This move is seen as a sign of PAG’s commitment to expanding its presence in the Indian market and supporting the growth of companies like Sekhmet Pharmaventures. With Mahil at the helm, Sekhmet Pharmaventures is well-positioned to capitalize on opportunities in the API market and drive growth and innovation in the pharmaceutical industry.

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 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’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.

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.

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 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 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.

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.

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 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.

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.

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.