Latest News on Sun Pharma
Delhi High Court grants interim relief to Sun Pharma in trademark dispute, restraining Alenvision from selling its NEXADOM medication amidst allegations of infringing on Sun Pharma’s NAXDOM trademark.
The Delhi High Court has granted interim relief to Sun Pharma in a trademark dispute over the name “NAXDOM”. The court has barred Alenvision from manufacturing and selling a drug called “NEXADOM”, which Sun Pharma claims is deceptively similar to their trademarked name.
The dispute began when Alenvision launched their drug “NEXADOM”, which Sun Pharma alleged was an attempt to capitalize on the reputation and goodwill of their own drug. Sun Pharma argued that the similarity in names would cause confusion among consumers and potentially harm their business.
The Delhi High Court agreed with Sun Pharma’s argument, stating that the name “NEXADOM” was indeed similar to “NAXDOM” and could cause confusion. The court granted an interim injunction, barring Alenvision from manufacturing, selling, or advertising their drug until the dispute is resolved.
This decision is a significant win for Sun Pharma, as it protects their trademark and prevents potential damage to their reputation. The company had argued that the similarity in names would not only cause confusion but also potentially harm their business. The court’s decision acknowledges the importance of protecting intellectual property rights, particularly in the pharmaceutical industry where consumer safety is a top priority.
The case highlights the importance of conducting thorough trademark searches before launching a new product. Alenvision’s failure to do so has resulted in a costly and time-consuming legal battle. The company will now have to rebrand their product, which could result in significant financial losses.
The decision also reinforces the need for companies to prioritize intellectual property protection. In today’s competitive market, a strong brand identity is crucial for success. Companies must take proactive steps to protect their trademarks, patents, and copyrights to prevent infringement and maintain their competitive edge.
In conclusion, the Delhi High Court’s decision to grant interim relief to Sun Pharma is a significant development in the trademark dispute over the name “NAXDOM”. The decision protects Sun Pharma’s intellectual property rights and prevents potential damage to their reputation. It also serves as a reminder to companies of the importance of prioritizing intellectual property protection and conducting thorough trademark searches before launching new products.
Dr Sharvil Patel of Zydus Lifesciences assumes the role of President at the Indian Pharmaceutical Association
Zydus Lifesciences’ Managing Director, Dr. Sharvil Patel, has taken over as the new President of the Indian Pharmaceutical Alliance (IPA). The IPA is a coalition of Indian pharmaceutical companies that aims to promote the interests of the domestic pharmaceutical industry.
As the President of the IPA, Dr. Patel will play a key role in shaping the organization’s policies and advocating for the interests of the Indian pharmaceutical industry. Under his leadership, the IPA is expected to focus on issues such as promoting innovation, improving access to medicines, and enhancing the competitiveness of the Indian pharmaceutical industry.
Dr. Patel brings a wealth of experience to the role, having served as the Managing Director of Zydus Lifesciences since 2014. During his tenure, Zydus Lifesciences has grown significantly, with a strong focus on research and development, manufacturing, and marketing of pharmaceutical products.
The Indian pharmaceutical industry is one of the largest and most competitive in the world, with a strong presence of domestic companies such as Zydus Lifesciences, Sun Pharma, and Cipla. The industry has been growing rapidly, driven by factors such as a large and growing population, an increasing burden of diseases, and a strong regulatory framework.
However, the industry also faces several challenges, including intense competition, pricing pressures, and regulatory hurdles. As the President of the IPA, Dr. Patel will need to navigate these challenges and work with stakeholders, including the government, regulators, and industry players, to promote the interests of the Indian pharmaceutical industry.
Dr. Patel’s appointment as the President of the IPA has been welcomed by the industry, with many stakeholders expressing confidence in his ability to lead the organization and promote the interests of the Indian pharmaceutical industry. His experience, expertise, and vision are expected to be valuable assets to the IPA, and his leadership is likely to have a positive impact on the industry as a whole.
Overall, Dr. Sharvil Patel’s appointment as the President of the IPA is a significant development for the Indian pharmaceutical industry. With his experience, expertise, and vision, he is well-positioned to lead the organization and promote the interests of the industry. As the industry continues to grow and evolve, Dr. Patel’s leadership will be critical in navigating the challenges and opportunities that lie ahead.
China’s reduction in import duties helps alleviate the impact of US tariffs on India’s pharmaceutical industry.
The Indian pharmaceutical industry is facing a complex global trade landscape, with contrasting developments in China and the US. China has reduced import duties on Indian pharma products by 30%, effectively enabling near-zero-cost access, providing a significant growth opportunity in a key Asian market. On the other hand, the US has announced a 100% tariff on imported branded and patented drugs, effective October 2025, which will put pressure on Indian companies reliant on US sales.
Companies such as Aurobindo Pharma, Lupin, and Sun Pharma have high US revenue exposure, making them vulnerable to the tariff. Aurobindo Pharma has a 46.7% exposure, Lupin has 35.8%, and Sun Pharma has 32.7%. In contrast, companies like Cipla, with a 14.1% exposure, are relatively insulated due to their focus on generics.
The US tariff primarily targets branded and patented drugs, which may exempt generics. However, the uncertainty surrounding the tariff’s scope and impact on generics can impede strategic planning and operational continuity. China’s reduced import duties, on the other hand, significantly improve the cost competitiveness of Indian exports, offering a valuable alternative market to mitigate US exposure.
To navigate this complex landscape, Indian pharmaceutical companies should consider strategic adjustments, such as portfolio segmentation, market diversification, and capex and manufacturing strategy. They should distinguish between US tariff-sensitive products and less vulnerable categories, expand their footprint in China and other Asian markets, and consider US production facilities to gain tariff exemptions.
Companies can leverage China’s favorable policies to diversify revenue streams, enhance margins, and mitigate geopolitical trade risks. Continuous monitoring of policy developments, revenue allocations, and strategic investments will be critical for Indian pharma to sustain global competitiveness in this dynamic landscape. By doing so, Indian pharmaceutical exporters can capitalize on growth opportunities in China and other markets, while minimizing the impact of the US tariff on their business.
Five pharmaceutical companies, including Sun Pharma and Zydus, have issued recalls for their products in the US market.
Sun Pharma, Zydus, and three other pharmaceutical companies have issued recalls for their products in the US market. The recalls were initiated due to various reasons, including contamination, labeling issues, and deviations from manufacturing standards.
Sun Pharma, one of India’s largest pharmaceutical companies, has recalled several batches of its products, including tablets and capsules, due to concerns over contamination and labeling errors. The company has stated that the affected products were manufactured at its facilities in India and were shipped to the US market.
Zydus, another major Indian pharmaceutical company, has also recalled several products, including tablets and injectables, due to issues with labeling and packaging. The company has cited manufacturing deviations as the reason for the recall.
The other three companies that have issued recalls are Accord Healthcare, Aurobindo Pharma, and Dr. Reddy’s Laboratories. Accord Healthcare has recalled several batches of its products, including tablets and capsules, due to concerns over contamination and labeling errors. Aurobindo Pharma has recalled several products, including tablets and injectables, due to issues with labeling and packaging. Dr. Reddy’s Laboratories has recalled several batches of its products, including tablets and capsules, due to concerns over contamination and manufacturing deviations.
The US Food and Drug Administration (FDA) has announced the recalls on its website, stating that the affected products may pose a risk to public health. The FDA has advised consumers to stop using the recalled products and return them to the manufacturer or their healthcare provider.
The recalls are a significant concern for the pharmaceutical industry, as they can impact the reputation of the companies involved and potentially harm consumers. The companies have stated that they are taking corrective actions to address the issues that led to the recalls and are working to ensure that their products meet the required standards of quality and safety.
The recalls also highlight the importance of regulatory oversight in ensuring the safety and efficacy of pharmaceutical products. The FDA plays a critical role in monitoring the pharmaceutical industry and taking enforcement actions when necessary to protect public health. The agency’s actions in this regard have helped to maintain the integrity of the US pharmaceutical market and ensure that consumers have access to safe and effective medications.
Several Indian pharmaceutical companies, including Glenmark, Granules, and Zydus, have issued recalls for certain medications in the US market due to concerns over quality, as reported by the US Food and Drug Administration (USFDA).
Several Indian pharmaceutical companies are recalling medicines from the US market due to various issues, as reported by the US Food and Drug Administration (USFDA). The recalls are related to manufacturing problems, impurities, and labeling errors. Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel due to complaints of a gritty texture. The recall, initiated on September 17, is classified as Class II, meaning the product may cause temporary or reversible health issues, but the risk of serious problems is low.
Other companies, such as Granules India, are also recalling products. Granules India is recalling over 49,000 bottles of a combination drug used to treat attention deficit hyperactivity disorder (ADHD) due to failed impurity and degradation tests. This recall is classified as Class III, indicating the product is unlikely to cause harm. Sun Pharma’s US subsidiary has recalled 1,870 kits of a renal imaging agent following failed dissolution tests, which is a Class II recall.
Zydus Pharmaceuticals is recalling 8,784 bottles of antiviral drug Entecavir tablets due to impurity and degradation concerns, also a Class II recall. Unichem Pharmaceuticals USA Inc has issued a Class I recall, the most serious type, for 230 bottles of medicine due to a label mix-up. This type of recall could lead to significant health risks if patients take the wrong medicine.
Despite these recalls, India has the highest number of USFDA-approved pharmaceutical plants outside the United States. The USFDA’s Enforcement Report highlights the need for strict quality control measures in the pharmaceutical industry. The recalls demonstrate the regulator’s efforts to ensure the safety and efficacy of drugs in the US market. The companies involved have initiated the recalls to protect public health and prevent potential harm to patients. The Class II and Class III recalls indicate that the risks associated with the products are relatively low, but the companies are taking proactive steps to address the issues and prevent future problems.
Stock Market Updates for Sun Pharma
Recent Updates
Several pharmaceutical companies, including Zydus, Sun Pharma, and Glenmark, have issued recalls of their medications in the US due to concerns regarding quality standards.
Several Indian pharmaceutical companies are recalling medicines from the US market due to various issues, including manufacturing problems, impurities, and labeling errors, as reported by the US Food and Drug Administration (USFDA). The recalls affect a range of products, including Azelaic Acid Gel, a combination drug for attention deficit hyperactivity disorder (ADHD), a renal imaging agent, Entecavir tablets, and other medicines.
Glenmark Pharmaceuticals is recalling 13,824 tubes of Azelaic Acid Gel due to complaints of a gritty texture, which may cause temporary or reversible health issues. Granules India is recalling over 49,000 bottles of a combination ADHD drug after it failed impurity and degradation tests. Sun Pharma’s US subsidiary is recalling 1,870 kits of a renal imaging agent following failed dissolution tests. Zydus Pharmaceuticals is recalling 8,784 bottles of Entecavir tablets due to impurity and degradation concerns. Unichem Pharmaceuticals has issued a Class I recall for 230 bottles of medicine because of a label mix-up, which could lead to significant health risks if patients take the wrong medicine.
The USFDA classifies recalls based on the level of risk associated with the product. Class I recalls are considered the most serious, as they could lead to significant health risks. Class II recalls are made when the use of a product may cause temporary or reversible health issues, but the risk of serious problems is low. Class III recalls are made when the product is unlikely to cause harm.
Despite these recalls, India has the highest number of USFDA-approved pharmaceutical plants outside the United States. The country’s pharmaceutical industry is a significant player in the global market, with many Indian companies exporting medicines to the US and other countries. The recalls highlight the importance of ensuring the quality and safety of pharmaceutical products, and the need for companies to adhere to strict manufacturing and testing standards.
The recalls are a result of the USFDA’s strict regulatory oversight, which aims to protect public health by ensuring that pharmaceutical products are safe and effective. The agency’s Enforcement Report provides information on recalls, warnings, and other regulatory actions taken against companies that fail to comply with USFDA regulations. The report helps to maintain transparency and accountability in the pharmaceutical industry, and ensures that companies take prompt action to address any issues related to their products.
Generic pharmaceutical companies dodge significant damage, avoiding a medical emergency.
India’s generic pharmaceutical companies are likely to continue business as usual despite US President Donald Trump’s 100% levy on pharmaceuticals. The tariff is targeted at branded and patented medicines, which may not directly impact generic companies. However, some companies like Sun Pharma, which generates a significant portion of its revenue from patented drugs in the US, may face headwinds. Sun Pharma’s drug sales in the US totalled $1.1 billion in FY25, accounting for around 17% of its total revenue.
Companies with manufacturing bases in the US, such as Sun Pharma, Dr Reddy’s, and Cipla, may shift production of higher-value specialty and niche drugs from India to their American facilities to cushion the blow. This move could drive companies to diversify export markets, recalibrate global strategies, and set up manufacturing bases in the US to safeguard access to the lucrative market.
Industry experts believe that Indian pharma companies need to diversify markets and innovate in complex generics and biosimilars to stay resilient in a changing global trade landscape. India’s pharma exports to the US were close to $10 billion last year, and the country services around 35% of US prescriptions with affordable generics. The Indian Pharmaceutical Alliance secretary general, Sudarshan Jain, emphasized that India plays a vital role in US healthcare by ensuring a steady supply of affordable medicines.
The pharma sector is awaiting more clarity on the announcement, as it did not specify whether specialty drugs, niche, or complex generic drugs are under its ambit. There is also uncertainty over the definition of “branded” drugs, which could impact companies like Granules India. Despite the uncertainty, experts believe that Indian pharma companies will need to reinforce their cost-efficiency advantage in bulk drugs and APIs, an area where the US is likely to favor India over other suppliers. They will also need to invest in next-generation opportunities, such as complex generics, peptides, and biosimilars, to remain competitive.
From Humble Beginnings to International Dominion
Dilip Shanghvi, the founder of Sun Pharmaceutical Industries (Sun Pharma), is one of India’s most prominent self-made billionaires. Born in 1955 in Amreli, Gujarat, Shanghvi grew up in Kolkata, where his father ran a small pharmacy shop. From a young age, Shanghvi helped in the shop, learning about medicines, customer management, and running a small business. These early lessons shaped his future as an entrepreneur.
Shanghvi’s journey began in 1983, when he launched Sun Pharma with a capital of ₹10,000 borrowed from his father. The company started with five psychiatric drugs, targeting mental health conditions largely ignored by big pharma companies. This focus on neglected therapeutic areas gave Sun Pharma a unique edge in the Indian market. Shanghvi’s strategic growth plan included focusing on niche segments, rational pricing of generics, mergers and acquisitions, and globalization.
Under Shanghvi’s leadership, Sun Pharma expanded its presence globally, operating in over 100 countries, with manufacturing facilities in India, the US, Canada, Israel, and other countries. The company’s revenue and net profit have grown significantly, with a market capitalization of over $40 billion. Shanghvi’s leadership style is characterized by humility, risk management, focus on people, and adaptability.
Shanghvi has overcome several challenges, including regulatory hurdles in the US, legacy issues with the Ranbaxy acquisition, and intense global competition. He has invested in compliance, streamlined operations, and focused on specialty drugs and innovation to overcome these challenges. Sun Pharma’s impact on the Indian pharma industry has been significant, creating affordable medicines, raising India’s image as the “pharmacy of the world,” and providing access to employment, research, and development.
Looking ahead, Sun Pharma will focus on specialty medicines, biologics, and biosimilars, building its presence in emerging markets, and investing in digital healthcare innovations. Shanghvi’s story is a testament to the power of vision, tenacity, and discipline, inspiring aspiring entrepreneurs to make a global impact. With a net worth of over $20 billion, Shanghvi is a true embodiment of entrepreneurship, and his legacy will continue to shape the pharmaceutical industry for years to come.
Key takeaways from Shanghvi’s story include the importance of identifying niche opportunities, focusing on people and innovation, and adapting to changing market conditions. His leadership style, which emphasizes humility, risk management, and discipline, has been instrumental in Sun Pharma’s success. As the company continues to grow and evolve, Shanghvi’s vision and legacy will remain a driving force behind its success.
Regulatory authorities have instructed Sun Pharma to restrict its Phase III Revefenacin study to only include patients with COPD who are currently on triple therapy.
Sun Pharmaceutical Industries Ltd, a prominent pharmaceutical company, has been instructed to limit the phase III study of Revefenacin to patients with Chronic Obstructive Pulmonary Disease (COPD) who are already receiving triple therapy. This decision comes as a regulatory measure to ensure the safe and effective evaluation of the medication.
Revefenacin is a long-acting muscarinic antagonist (LAMA) that is being developed for the treatment of COPD, a chronic and progressive lung disease that makes it difficult to breathe. The phase III study is designed to assess the efficacy and safety of Revefenacin in patients with moderate to severe COPD.
The decision to limit the study to patients receiving triple therapy is significant, as it indicates that the regulatory authorities want to evaluate the medication in a specific patient population. Triple therapy typically consists of a combination of three medications: a LAMA, a long-acting beta-agonist (LABA), and an inhaled corticosteroid (ICS). By limiting the study to patients already receiving triple therapy, the regulators aim to assess the effectiveness of Revefenacin in a real-world setting, where patients are often prescribed multiple medications to manage their condition.
The limitation of the study to triple therapy patients may also be intended to minimize the risk of adverse events and ensure the safety of participants. COPD patients often have multiple comorbidities and are prone to experiencing adverse events, so it is essential to evaluate the medication in a controlled and monitored environment.
The regulatory decision may have implications for Sun Pharma’s development plans for Revefenacin. The company may need to adjust its clinical trial design and patient recruitment strategies to comply with the new requirements. Additionally, the limitation of the study to triple therapy patients may impact the medication’s potential labeling and market positioning.
In conclusion, the instruction to limit the phase III study of Revefenacin to triple therapy COPD patients is a significant regulatory development that may impact the medication’s development and commercialization. Sun Pharma will need to adapt to the new requirements and ensure that the study is conducted in a way that meets regulatory standards and ensures patient safety. The outcome of the study will be crucial in determining the medication’s efficacy and safety in a specific patient population, and its potential to become a treatment option for COPD patients.
Sun Pharma has revamped its leadership team, and the stakes are high.
Sun Pharma, one of India’s largest pharmaceutical companies, has undergone a significant leadership transition. Dilip Shanghvi, the company’s founder and promoter, has transitioned to the role of executive chairman, while Kirti Ganorkar, who headed the India business, has taken over as managing director. Additionally, Shanghvi’s son Aalok has been appointed as chief operating officer and will oversee the company’s North America business, which is being run by Richard Ascroft, a former Takeda Pharmaceuticals executive.
The leadership changes are part of a “structured and forward-looking succession planning process” aimed at bolstering the company’s global innovative drug pipeline. Sun Pharma has been focusing on its speciality business, particularly in the US, where generic price erosion and policy uncertainties have impacted the company’s sales. The company has delivered a compound annual growth rate (CAGR) of 10% in sales between 2018-19 and 2024-25 and is expected to maintain a similar growth rate for the next three years.
The transition is significant, as it involves the company’s globally critical functions, including the India business, the US, and its long-term speciality focus. Industry experts believe that the timing of the transition is opportune, as the company is in good shape and its business is strong. The changes are aimed at making the company more professionally driven, while still maintaining the influence of the promoter family.
Aalok Shanghvi, who has been with the company for over 15 years, has been groomed to take over key responsibilities. He will oversee the North America business, which is critical for the company’s growth. Richard Ascroft, who has been appointed to run the North America business, brings significant experience in the biopharmaceutical industry. The company has also elevated Shanghvi’s daughter Vidhi to whole-time director and appointed Jayashree Satagopan as chief financial officer designate.
The transition is seen as a planned move to balance the company’s global ambitions with the grooming of the next generation of leaders. Experts believe that the company is attempting to preserve institutional memory and culture while allowing newer leadership to take over operational responsibilities. The changes are expected to help Sun Pharma compete better in the global market, protect margins, and accelerate launches of new products. Overall, the leadership transition is a significant development for Sun Pharma, as it aims to strengthen its position in the global pharmaceutical industry.
Prominent pharmaceutical companies such as Sun Pharma, Cipla, Dr Reddy’s, Zydus Lifesciences, Divi’s Labs, and Torrent Pharma are navigating the complexities of the pharma value chain.
The pharmaceutical industry is complex, with various segments such as innovator products, generics, branded generics, and API. Indian companies are making headway globally, and understanding the industry’s intricacies is crucial for those seeking opportunities. Innovator companies undertake significant risks, with only 8 out of 100 molecules crossing the finish line, and patent protection is the incentive for undertaking this risk. Roche, a leading innovator, reported a 30% PAT margin in FY24, with R&D expenses at 20% of sales.
Indian pharma is sustained by generics, but companies like Sun Pharma and Glenmark Pharma are making modest beginnings in innovation. Sun Pharma’s innovative medicine segment has 11 products, including Ilumya, which reported sales of $680 million in FY25. Glenmark Pharma’s Ichnos Glenmark Innovation (IGI) recently entered a licensing agreement with AbbVie for its ISB 2001, receiving $700 million in milestone payments.
The generics business is dependent on the level of competition, with prices declining sharply as the number of competitors increases. Branded generics, however, offer higher value, with companies like Mankind Pharma and Torrent Pharma generating significant revenues from their branded portfolios. Complex generics, such as Lupin’s generic Spiriva, hold a value proposition in regulated markets, with strong revenue streams and above-average margins.
Biosimilars are a growing segment, with companies like Biocon developing portfolios. The biosimilar approval process involves clinical trials, increasing the cost of development to $200-300 million. CRDMO (contract research and development and manufacturing outsourcing) is another emerging segment, with companies like Divi’s Labs and Anthem Biosciences securing a portion of the innovators’ drug development process.
The API business is largely commoditized, with prices dependent on tonnage. However, high-potent APIs and complex manufacturing processes can fetch higher margins. India has focused on API development with its PLI schemes, and companies like Aurobindo Pharma are establishing API facilities.
For investors, a strong branded generic base supplemented by a wide innovator portfolio is essential for trail-blazing growth. Complex generics and CRDMO are emerging sectors, with China+1 and the US Biosecure Act providing tailwinds. The right mix of business segments and prospects is crucial for growth, and understanding the industry’s intricacies is essential for those seeking opportunities in the pharmaceutical sector.
Key takeaways include:
* Innovator companies undertake significant risks, but patent protection provides an incentive.
* Indian pharma is sustained by generics, but companies are making modest beginnings in innovation.
* Branded generics offer higher value, with companies generating significant revenues from their branded portfolios.
* Complex generics hold a value proposition in regulated markets, with strong revenue streams and above-average margins.
* Biosimilars are a growing segment, with companies developing portfolios.
* CRDMO is an emerging segment, with companies securing a portion of the innovators’ drug development process.
* The API business is largely commoditized, but high-potent APIs and complex manufacturing processes can fetch higher margins.
Pharmaceutical and healthcare industries excel in the BT500 2025 rankings.
The Indian healthcare sector has experienced a significant surge in profit, with a 29% rise in profit after tax (PAT) in the fiscal year 2025. This makes it the second-fastest growing sector in the country, surpassed only by the non-ferrous metals sector. The impressive growth of the healthcare sector has caught the attention of top private equity (PE) and venture capital funds worldwide, which are now competing to invest in this rapidly expanding market.
Over the past five years, the healthcare sector has received a substantial $13 billion in PE funding, accounting for 8-9% of the total PE activity in India. This represents a significant increase from 2018, when the sector accounted for only 2% of the total PE activity. The influx of investments has contributed to the sector’s remarkable growth, with major players such as Sun Pharma and Apollo Hospitals reporting substantial profits.
Sun Pharma, for instance, has reported a billion-dollar-plus PAT, while Apollo Hospitals has seen growing margins. The healthcare sector has emerged as a vital profit engine for India Inc., with its growth outpacing many other sectors. The sector’s attractiveness to investors can be attributed to India’s large and growing population, increasing healthcare needs, and the government’s efforts to improve healthcare infrastructure and services.
The significant investment in the healthcare sector is expected to continue, driven by the growing demand for quality healthcare services and the government’s initiatives to promote the sector. As the sector continues to expand, it is likely to attract more investments from PE and venture capital funds, further driving growth and profitability. With its impressive growth trajectory, the Indian healthcare sector is poised to remain a key driver of the country’s economic growth and a major destination for investments in the coming years.
US FDA issues ‘Official Action Indicated’ status to Sun Pharma’s Halol facility due to recurring safety violations.
The US Food and Drug Administration (FDA) has flagged Sun Pharma’s Halol plant in India with an “Official Action Indicated” (OAI) status. This decision comes after the plant was found to have repeated safety breaches. The OAI status is a serious warning from the FDA, indicating that the plant’s regulatory and compliance issues are severe enough to warrant enforcement action.
The Halol plant, which is one of Sun Pharma’s largest manufacturing facilities, has been under scrutiny by the FDA for several years. In 2015, the FDA issued a warning letter to the plant, citing several deficiencies, including inadequate quality control procedures and a lack of proper cleaning and sanitation practices. Despite efforts to address these issues, the plant has continued to experience repeat safety breaches.
The FDA’s most recent inspection of the Halol plant, which took place in February 2023, revealed several serious deficiencies, including inadequate procedures for cleaning and sanitizing equipment, inadequate quality control procedures, and a lack of proper documentation. The FDA also found that the plant had failed to implement adequate corrective actions to address previous deficiencies.
The OAI status is a significant blow to Sun Pharma, as it could lead to further regulatory action, including the possibility of import alerts or even a complete shutdown of the plant. The status also raises concerns about the safety and efficacy of products manufactured at the plant, which could have serious implications for patients who rely on these medications.
Sun Pharma has stated that it is taking immediate action to address the FDA’s concerns and is working to implement corrective actions to ensure compliance with regulatory requirements. However, the company’s history of repeat safety breaches at the Halol plant raises questions about its ability to ensure the quality and safety of its products.
The FDA’s decision to flag the Halol plant with an OAI status is a reminder of the importance of rigorous regulatory oversight in ensuring the safety and efficacy of pharmaceutical products. It also highlights the need for pharmaceutical companies to prioritize quality and compliance, and to take prompt and effective action to address any deficiencies or safety breaches. As the situation develops, it will be important to monitor the FDA’s next steps and Sun Pharma’s efforts to address the regulatory issues at the Halol plant.
Sun Pharma and Lupin are developing an anti-obesity oral medication to reduce costs and cater to those hesitant about injections.
The Indian pharmaceutical companies, Sun Pharma and Lupin, are developing oral semaglutide pills to address obesity and injection aversion. Currently, leading anti-obesity drugs like Mounjaro and Wegovy are available in injectable form, limiting accessibility and patient comfort. The Drugs Controller General of India (DCGI) has given Sun Pharma permission for a large-scale clinical trial to test its semaglutide tablets, while Lupin has received the green light for its bioequivalence study.
Obesity is becoming a significant public health challenge in India, with a projected 450 million overweight and obese adults by 2050. Experts believe that the injectable form of semaglutide is more effective for weight loss, but the oral variant could improve accessibility and patient comfort. Other Indian companies, such as Dr. Reddy’s Laboratories Ltd, Cipla Ltd, and Mankind Pharma, are also developing generic versions of semaglutide.
The development of these anti-obesity drugs is significant, and experts urge strict medical supervision and caution against misuse. Dr. Balram Bhargava, former director general of the Indian Council of Medical Research (ICMR), said that these drugs are “wonder drugs and novel inventions” but should be used under strict medical supervision. He added that irrational use of these drugs could have serious consequences and that they are suitable as a second line of treatment for individuals who are obese and diabetic.
The key takeaways from this development are:
1. Sun Pharma and Lupin are developing oral semaglutide pills to address obesity and injection aversion.
2. Regulatory approvals have been granted for Phase III trials and bioequivalence studies.
3. India faces an obesity burden of 450 million adults by 2050.
4. Experts urge strict medical supervision and caution against misuse.
5. Generic versions may flood the market next year, reshaping affordability and access.
Overall, the development of oral semaglutide pills and the upcoming availability of generic versions could significantly impact the treatment of obesity in India. However, it is crucial to ensure that these drugs are used responsibly and under strict medical supervision to avoid misuse and potential consequences.
Sun Pharma’s application for a bioequivalence and phase III trial waiver for its Sitagliptin, Glimepiride, and Metformin fixed-dose combination has been rejected by the CDSCO.
Sun Pharmaceutical Industries, a prominent pharmaceutical company, has faced a setback in its attempt to secure approval from the Central Drugs Standard Control Organisation (CDSCO) for a bioequivalence (BE) study and Phase III clinical trial waiver for its fixed-dose combination (FDC) drug containing sitagliptin, glimepiride, and metformin.
The CDSCO, India’s drug regulatory agency, has denied the waiver, which means that Sun Pharma will now have to conduct a full Phase III clinical trial to demonstrate the safety and efficacy of the FDC drug. This decision is likely to delay the launch of the drug in the Indian market.
The FDC drug in question combines three established anti-diabetic medications: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor; glimepiride, a sulfonylurea; and metformin, a biguanide. The combination of these drugs is intended to provide a convenient and effective treatment option for patients with type 2 diabetes.
The BE study and Phase III clinical trial waiver are crucial steps in the regulatory approval process for new drugs in India. The BE study is designed to demonstrate that the generic version of a drug is equivalent to the branded version in terms of pharmacokinetic and pharmacodynamic parameters. The Phase III clinical trial is a pivotal study that evaluates the safety and efficacy of a drug in a large population of patients.
Sun Pharma’s failure to secure the CDSCO nod for the BE study and Phase III waiver may be due to various reasons, including concerns about the safety and efficacy of the FDC drug or the adequacy of the data submitted by the company. The company will now have to conduct a full Phase III clinical trial, which will involve significant time, effort, and resources.
The setback is likely to impact Sun Pharma’s business plans and revenue projections for the FDC drug. However, the company can still pursue the development and launch of the drug in other markets, including the United States and Europe, where the regulatory requirements may be different. The company will have to re-strategize and re-submit its application to the CDSCO, addressing the concerns and objections raised by the regulator.
Prohance D by Sun Pharma empowers individuals with diabetes to maintain an active lifestyle.
Sun Pharmaceutical Industries Limited, India’s leading pharmaceutical company, has launched a large-scale digital video campaign for Prohance D Diabetes Care, a nutritional supplement designed for individuals managing diabetes. The campaign, titled “Dekhta Hoon Nahi, Dikhata Hoon,” aims to address the emotional impact of diabetes on people’s lives, particularly the unpredictability of blood sugar levels that can make planning and living spontaneously challenging.
The campaign highlights how this unpredictability can lead to a life of “maybes” and hesitation, affecting not only daily routines but also relationships. The message is conveyed through a heartwarming story of a child who notices his father’s hesitation to commit to plans due to his diabetes and decides to help him. This narrative approach is a departure from the typical medicalized conversation in the diabetes category, instead focusing on the emotional truths of living with the condition.
By taking a more human approach, Prohance D aims to connect with its audience on a deeper level, emphasizing that better blood glucose management and prolonged energy can empower people with diabetes to live life to the fullest. The campaign, conceptualized by Curativity, Mumbai, reflects Sun Pharma’s belief that meaningful change begins with connection and understanding. Prohance D is positioned as a solution that can help individuals with diabetes move from uncertainty to action, embracing life’s plans and nurturing relationships.
The campaign’s focus on emotional storytelling and relatability is a strategic choice, as it allows Prohance D to stand out in a category often dominated by medical jargon and statistics. By emphasizing the human impact of diabetes and the benefits of better blood glucose management, Prohance D aims to resonate with its target audience and establish a strong connection with them. Overall, the campaign is a significant effort by Sun Pharma to promote Prohance D Diabetes Care and support individuals with diabetes in managing their condition and living a more fulfilling life.
Gujarat Emerges as a Thriving Pharmaceutical Hub in India
Gujarat is playing a vital role in India’s pharmaceutical industry, driven by government initiatives and investment opportunities. The state is home to major pharmaceutical companies such as Sun Pharma, Zydus Cadila, and Intas Pharmaceuticals, contributing significantly to the country’s pharmaceutical output. The North Gujarat region, in particular, accounts for 12% of the state’s pharmaceutical manufacturing, making it a crucial hub for the industry.
Mehsana is a notable location in North Gujarat, offering substantial prospects in bulk drug production, Active Pharmaceutical Ingredients (APIs), intermediates, and formulations. Torrent Pharma, a prominent company in the region, operates a USFDA-approved facility, producing insulin for Novo Nordisk, making it India’s sole contract manufacturer of insulin for the company. This highlights the region’s capabilities in producing high-quality pharmaceutical products.
Patan, another district in North Gujarat, is also making significant contributions to the pharmaceutical sector, with a strong base of micro, small, and medium enterprises (MSMEs) specializing in injectables and formulations. The district is also gaining traction in the MedTech sector, with companies producing vascular interventional devices and medical equipment, such as hospital trolleys. The region’s educational institutions support this growth, with a focus on healthcare and pharmaceutical education.
The region’s comprehensive healthcare network, comprising 318 Primary Health Centres and 75 Community Health Centres, provides robust healthcare services across government and private sectors. This network is expected to be further strengthened by the forthcoming Vibrant Gujarat Regional Conference (VGRC), which aims to foster collaboration among the government, industry, and academia. The conference is expected to have a significant impact on the pharmaceutical sector’s trajectory, driving growth and innovation in the region.
Overall, North Gujarat is poised to become a major hub for the pharmaceutical industry, driven by government support, investment opportunities, and a strong network of educational institutions and healthcare services. The region’s potential for growth and innovation is significant, and the forthcoming VGRC is expected to play a key role in shaping the sector’s future. With its strong foundation in pharmaceutical manufacturing, North Gujarat is well-positioned to contribute to India’s growing pharmaceutical industry.
Market Outlook for Generic Drugs in Saudi Arabia 2025-2033: Key Players Include Teva, Viatris, Sandoz, Sun Pharma, Cipla, Aurobindo Pharma, Lupin, Hikma Pharma, STADA Arzneimittel, and Dr. Reddy’s Labs.
The Saudi Arabia Generic Drugs Market is expected to grow significantly, reaching US$ 8.11 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 8.02% from 2025 to 2033. This growth is attributed to increased healthcare needs, government efforts to reduce pharmaceutical expenditure, and growing awareness of cost-effective alternatives. The market is also driven by local manufacturing and government support for generics.
The demand for generic medications in Saudi Arabia is increasing rapidly, driven by the government’s attempts to reduce reliance on imported branded medicines and lower healthcare spending. The Saudi Food and Drug Authority (SFDA) has simplified the process of generic approvals, encouraging local and foreign manufacturers to increase their generic offerings.
Key growth drivers in the Saudi Arabia Generic Drugs Market include government support and cost containment initiatives, increasing incidence of chronic diseases, and growing local production capability. The government has focused on making healthcare more affordable through greater generic drug promotion, and initiatives such as the “Procedure to deal with patents when registering generic products in SFDA” have been introduced to facilitate the growth of the generic drug market.
However, the market also faces challenges, including public perception and brand loyalty, as well as regulatory and quality control complexity. Despite these challenges, the market is expected to continue growing, driven by the increasing demand for cost-effective generic drugs.
The report provides an in-depth analysis of the Saudi Arabia Generic Drugs Market, including market trends, forecast, and key players analysis. The market is segmented by type, route of administration, therapeutic area, distribution channel, and region. Key players in the market include Teva Pharmaceutical Industries Ltd., Viatris Inc., Sandoz Group AG, and Sun Pharmaceutical Industries Ltd.
The report also highlights the growing trend of online generic drugs in Saudi Arabia, with digital platforms and e-pharmacies facilitating easier price comparisons and prescription-based generics ordering for consumers. The online generic drug segment is expected to receive robust traction, particularly in urban regions such as Riyadh and Jeddah.
In terms of therapeutic areas, the report highlights the growing demand for generic drugs in areas such as respiratory, oncology, and infectious diseases. The report also provides an analysis of the regulatory framework of generic drugs in Saudi Arabia, including the role of the SFDA and the challenges faced by manufacturers in complying with regulatory requirements.
Overall, the Saudi Arabia Generic Drugs Market is expected to continue growing, driven by government support, increasing demand for cost-effective generic drugs, and growing local production capability. The report provides a comprehensive analysis of the market, including key trends, challenges, and opportunities, and is a valuable resource for companies looking to enter or expand their presence in the Saudi Arabian generic drugs market.
CDSCO Panel Approves Sun Pharma’s Phase IV Clinical Trial for Dual Release Pantoprazole in Treating Gastroesophageal Reflux Disease (GERD)
Sun Pharma, a leading pharmaceutical company, has announced that its Phase IV study on dual release pantoprazole for the treatment of Gastroesophageal Reflux Disease (GERD) has received acceptance from the Central Drugs Standard Control Organization (CDSCO) panel. This milestone marks a significant step forward in the development of a new treatment option for patients suffering from GERD.
GERD is a chronic condition characterized by the backflow of stomach acid into the esophagus, causing symptoms such as heartburn, regurgitation, and difficulty swallowing. Pantoprazole is a proton pump inhibitor (PPI) that works by reducing the amount of acid produced in the stomach. The dual release formulation of pantoprazole developed by Sun Pharma is designed to provide both immediate and sustained release of the medication, offering enhanced efficacy and convenience for patients.
The Phase IV study, which was conducted in accordance with CDSCO guidelines, aimed to evaluate the safety and efficacy of dual release pantoprazole in patients with GERD. The study’s findings were presented to the CDSCO panel, which has now accepted the results. This acceptance is a crucial step towards obtaining regulatory approval for the new formulation.
The CDSCO panel’s acceptance of the study’s results is a testament to the rigor and quality of Sun Pharma’s research and development efforts. The company’s commitment to improving patient outcomes and addressing unmet medical needs is evident in its pursuit of innovative treatment options like dual release pantoprazole.
With this development, Sun Pharma is poised to bring a new treatment option to patients with GERD, offering them a potentially more effective and convenient way to manage their symptoms. The company’s expertise in formulation development and its strong regulatory capabilities have enabled it to navigate the complex regulatory landscape and achieve this milestone.
As the pharmaceutical industry continues to evolve, companies like Sun Pharma are at the forefront of innovation, driving progress in the development of new treatments and therapies. The acceptance of the Phase IV study on dual release pantoprazole by the CDSCO panel is a significant achievement, demonstrating Sun Pharma’s capabilities and commitment to delivering high-quality, effective treatments to patients.
Volini by Sun Pharma Introduces ‘Uparna’, a Groundbreaking Initiative for Devotees Traveling to Pandharpur
Sun Pharmaceutical Industries Limited, India’s leading pharmaceutical company, has launched a unique initiative through its pain relief brand, Volini. During the annual Pandharpur Wari pilgrimage in Maharashtra, one of the oldest and most significant spiritual journeys in the state, Volini introduced the “Volini Uparna”. This innovative product is a modern twist on the traditional Uparna, a multipurpose cloth worn by pilgrims over their shoulders, symbolizing comfort, resilience, and faith.
The Uparna has been redesigned to include a specially designed sleeve that holds Volini Gel, providing instant pain relief for sore muscles and joints. This allows pilgrims to access pain relief on the go, making their 21-day, 250-kilometer journey more comfortable. The initiative was launched at Pirachi Kuroli, a key rest point along the pilgrimage route, where local residents and the Volini team distributed the Uparnas to pilgrims.
This effort is an extension of Volini’s long-standing tradition of supporting the Warkaris, the pilgrims who undertake the Pandharpur Wari journey, through on-ground pain relief camps. The Volini Uparna reflects the brand’s promise of “No Time for Pain” and positions Volini as a meaningful cultural companion, rather than just a pain relief solution. By incorporating its core product into a culturally significant item, Sun Pharma has demonstrated a deep understanding of consumer needs and cultural heritage.
The Volini Uparna is an innovative example of how a brand can blend tradition and utility to create a meaningful and functional product. It showcases Volini’s commitment to providing pain relief solutions that are both effective and culturally relevant. With over three million pilgrims participating in the Pandharpur Wari each year, the Volini Uparna has the potential to make a significant impact on the lives of those undertaking this spiritual journey. By reimagining a traditional item with a modern twist, Volini has created a unique and memorable brand experience that is likely to resonate with consumers and reinforce its position as a leader in the Indian pharmaceutical industry.
Delhi High Court Grants Sun Pharma Reprieve by Restraining Use of BERIVITAL, BEZOLIC, and DOZE-30 Due to Trademark Infringement
The Delhi High Court has granted relief to Sun Pharma, a prominent pharmaceutical company, by barring the use of three trademarks – BERIVITAL, BEZOLIC, and DOZE-30 – due to trademark infringement. This decision is a significant victory for Sun Pharma, as it protects the company’s intellectual property rights and prevents other companies from using similar trademarks that could cause confusion among consumers.
The court’s ruling is based on the principle that a trademark is a unique identifier of a company’s products or services, and its use by another company can lead to confusion and dilution of the brand. In this case, the defendants were found to be using trademarks that were similar to Sun Pharma’s registered trademarks, which could have caused harm to the company’s reputation and business.
The Delhi High Court’s decision highlights the importance of protecting intellectual property rights, particularly in the pharmaceutical industry where brand reputation and trust are crucial. The court’s ruling sends a strong message to companies that attempt to infringe on registered trademarks, and it demonstrates the court’s commitment to upholding the law and protecting the rights of legitimate trademark owners.
The trademarks in question, BERIVITAL, BEZOLIC, and DOZE-30, are likely to be associated with specific products or therapies, and the court’s decision ensures that Sun Pharma’s products will not be confused with those of other companies. This decision also reinforces the importance of conducting thorough trademark searches and clearance procedures before launching new products or services.
Overall, the Delhi High Court’s decision is a significant win for Sun Pharma, and it demonstrates the company’s commitment to protecting its intellectual property rights. The ruling also serves as a reminder to other companies to respect the trademark rights of others and to take necessary steps to avoid infringement. By protecting its trademarks, Sun Pharma can maintain its brand integrity and continue to provide high-quality products to its customers without fear of confusion or dilution.
Sun Pharma Reports Favorable Phase 3 Trial Outcomes for Tildrakizumab in Treating Psoriatic Arthritis
Sun Pharma has announced positive top-line results from two phase 3 clinical trials, INSPIRE-1 and INSPIRE-2, evaluating the efficacy and safety of tildrakizumab 100 mg (Ilumya) in patients with active psoriatic arthritis. The studies, which enrolled over 800 patients, met their primary endpoint, demonstrating significant improvements in psoriatic arthritis signs and symptoms compared to placebo after 24 weeks of treatment.
Tildrakizumab, a high-affinity humanized immunoglobulin antibody, targets the p19 subunit of IL-23 and has been previously approved for the treatment of plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. The INSPIRE-1 and INSPIRE-2 studies were designed to assess the efficacy and safety of tildrakizumab in patients with active psoriatic arthritis, with patients randomized to receive either tildrakizumab 100 mg or placebo.
The primary endpoint of the studies was the proportion of participants achieving an American College of Rheumatology 20% response criteria (ACR20) at Week 24, which was met in both INSPIRE-1 and INSPIRE-2. Secondary efficacy endpoints at 24 weeks included ACR50, ACR70, and Psoriasis Area Severity Index (PASI) 75. The safety data observed in the studies aligns with the well-documented safety profile of tildrakizumab for moderate-to-severe plaque psoriasis.
According to Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma, “These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis.” The company plans to present the full results at upcoming conferences and publish them in a peer-reviewed medical journal.
The findings support the potential regulatory submission of Ilumya for the treatment of active psoriatic arthritis in the US. Tildrakizumab is also being evaluated for the treatment of stable nonsegmental vitiligo. The positive results from the INSPIRE-1 and INSPIRE-2 studies demonstrate the potential of tildrakizumab as a treatment option for patients with active psoriatic arthritis, and further research is needed to fully understand its efficacy and safety in this patient population.
Overall, the announcement from Sun Pharma highlights the potential of tildrakizumab as a treatment option for patients with active psoriatic arthritis, and the company’s commitment to advancing the development of this therapy for patients in need. The results of the INSPIRE-1 and INSPIRE-2 studies are a significant step forward in the treatment of psoriatic arthritis, and further research is expected to provide additional insights into the efficacy and safety of tildrakizumab in this patient population.
Authorities with the DCA have seized counterfeit Levipil 500 tablets.
The Telangana State Drugs Control Administration (DCA) has cracked down on counterfeit medication in the region, seizing fake Levipil 500 tablets, which are used to treat epilepsy. The tablets were falsely labeled as products of Sun Pharma Laboratories Ltd, a reputable pharmaceutical company. The DCA’s special teams conducted raids at two locations: Arvind Pharma Distributors in Kavadiguda and Venu Medical Agencies in Karimnagar, where the counterfeit tablets were being distributed.
The raids took place on July 4 and 5, 2025, and the DCA was able to confirm the counterfeit status of the tablets by cross-checking them with Sun Pharma’s official records. The seizure of these fake tablets is a significant achievement for the DCA, as it helps to protect the public from the dangers of counterfeit medication. Counterfeit drugs can be ineffective, toxic, or even fatal, and it is essential to ensure that all medication is genuine and safe for consumption.
The DCA is now investigating the sources of the counterfeit tablets and will take legal action against those involved. The administration is also urging the public to report any suspicious drug production activities, including those involving narcotics and psychotropic substances, in any area. To facilitate this, the DCA has set up a toll-free number, 1800-599-6969, which is available from 10:30 am to 5 pm on weekdays. Citizens can use this number to report any illegal drug activities, and the DCA will take prompt action to address the issue.
The DCA’s efforts to combat counterfeit medication are crucial in ensuring the safety and well-being of the public. The administration’s actions demonstrate its commitment to protecting the health and welfare of the people of Telangana, and its efforts will help to prevent the spread of counterfeit medication in the region. By reporting suspicious activities and working together, the public and the DCA can help to create a safer and healthier environment for everyone.
Fake versions of Sun Pharma’s cholesterol-lowering medications confiscated in Hyderabad
In a significant crackdown on counterfeit pharmaceuticals, the Telangana Drugs Control Administration (DCA) has seized fake versions of heart medications Rosuvas F 20 and Rosuvas F 10 in Hyderabad’s Koti area. The counterfeit cholesterol-lowering drugs, labeled under the name of Sun Pharmaceutical Industries Ltd, were discovered during intelligence-led raids on June 19, 2025. The DCA conducted surprise inspections at two distribution firms, Ganga Pharma Distributors and Sri Nandini Pharma, where they found fake versions of Rosuvas F 20 and Rosuvas F 10 with forged manufacturing dates and expiry dates.
Sun Pharmaceutical Industries Ltd has confirmed that these products were not manufactured by them, leaving no doubt that the drugs seized were counterfeit and illegal. The drugs, containing Rosuvastatin and Fenofibrate, are commonly prescribed to treat high cholesterol and triglyceride levels, and are crucial in preventing heart attacks, strokes, and angina. The DCA has warned that counterfeit drugs endanger patients’ lives, failing to treat the disease and leading to severe health complications.
The value of the seized counterfeit drugs is estimated at ₹3 lakh, and investigations are ongoing to trace the origin of the fake supply chain and bring the perpetrators to justice. This incident raises serious concerns about the integrity of the pharmaceutical distribution system, especially as India battles rising cases of lifestyle-related diseases, including heart ailments caused by processed food consumption and sedentary habits.
The proliferation of counterfeit heart medicines presents a dangerous new challenge to India’s already strained healthcare system. With lifestyle diseases on the rise, access to authentic and effective medication is more critical than ever. The DCA has vowed to intensify inspections, ensure supply chain vigilance, and protect public health from such deceptive and harmful practices. The agency’s efforts aim to prevent patients from unknowingly consuming fake medicines, which can lead to major cardiovascular events and negate the benefits of legitimate treatment.
The seizure of counterfeit drugs is a significant step towards ensuring public health safety, and the DCA’s commitment to protecting the pharmaceutical supply chain is crucial in preventing the spread of counterfeit medicines. The incident highlights the need for increased vigilance and action against counterfeit pharmaceuticals, which pose a significant threat to public health. By cracking down on counterfeit drugs, the DCA aims to safeguard the health and well-being of citizens, especially those suffering from lifestyle-related diseases.
Authorities in Hyderabad confiscate fake Sun Pharma cholesterol medication valued at Rs 3 lakhs
In a significant crackdown on counterfeit medicines, a large consignment of fake Sun Pharma cholesterol-lowering drugs worth approximately Rs 3 lakhs was seized in Hyderabad. The seizure is a result of a coordinated effort between law enforcement agencies and pharmaceutical regulatory bodies to combat the growing menace of counterfeit medicines in India.
The counterfeit drugs, which were designed to mimic the packaging and appearance of genuine Sun Pharma products, were intended to be sold in the market as legitimate medications. However, they were found to be of inferior quality and could have posed serious health risks to consumers if ingested.
The seizure highlights the gravity of the counterfeit medicines problem in India, which is estimated to be worth thousands of crores of rupees. Counterfeit medicines can cause harm to patients, damage the reputation of pharmaceutical companies, and undermine the trust of consumers in the healthcare system.
Sun Pharma, one of India’s largest pharmaceutical companies, has been a victim of counterfeiting in the past, with several instances of fake versions of its medicines being seized by authorities. The company has been working closely with law enforcement agencies and regulatory bodies to prevent the circulation of counterfeit medicines and protect its brand reputation.
The seizure of fake Sun Pharma cholesterol-lowering drugs in Hyderabad is a significant success for the authorities, who have been cracking down on counterfeit medicines in recent years. The government has implemented various measures to prevent counterfeiting, including the use of track-and-trace technology, serialization, and strict regulation of pharmaceutical manufacturing and distribution.
In addition to the seizure, the authorities are also investigating the source of the counterfeit medicines and the individuals involved in their manufacture and distribution. The perpetrators are likely to face severe penalties, including fines and imprisonment, for their role in producing and selling fake medicines.
Overall, the seizure of fake Sun Pharma cholesterol-lowering drugs in Hyderabad is a welcome step in the fight against counterfeit medicines in India. It highlights the need for continued vigilance and cooperation between law enforcement agencies, pharmaceutical companies, and regulatory bodies to prevent the circulation of fake medicines and protect the health and well-being of consumers. By working together, it is possible to reduce the incidence of counterfeiting and ensure that patients receive genuine, effective, and safe medicines.
Sun Pharmaceutical Industries Appoints Kirti Ganorkar as MD Amidst Top-Level Restructuring – MSN
Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, has announced a significant leadership overhaul with the appointment of Kirti Ganorkar as its new Managing Director. This move is part of a broader effort to revamp the company’s leadership structure and drive growth in an increasingly competitive pharmaceutical landscape.
Ganorkar, who has been with Sun Pharma for over two decades, will take over as Managing Director, replacing Dilip Shanghvi, the company’s founder and current Managing Director. Shanghvi will continue to serve as the company’s Chairman, providing strategic guidance and oversight.
The leadership change is seen as a significant development in Sun Pharma’s history, marking a new era of leadership and direction for the company. Under Ganorkar’s stewardship, Sun Pharma is expected to focus on innovation, research, and development, as well as strengthening its presence in key markets, including the United States and emerging economies.
Ganorkar’s appointment is also seen as a testament to Sun Pharma’s commitment to developing and promoting talent from within its ranks. With his extensive experience and knowledge of the pharmaceutical industry, he is well-equipped to navigate the complexities of the global pharmaceutical market and drive growth for the company.
The leadership overhaul also includes the appointment of other key executives, including a new Chief Operating Officer and a new Head of Research and Development. These appointments are aimed at strengthening Sun Pharma’s operational capabilities, enhancing its research and development pipeline, and driving innovation across its portfolio.
Sun Pharma’s leadership change comes at a time when the pharmaceutical industry is facing significant challenges, including increasing competition, regulatory pressures, and evolving patient needs. However, with its strong foundation, diverse portfolio, and commitment to innovation, Sun Pharma is well-positioned to navigate these challenges and capitalize on emerging opportunities.
Under Ganorkar’s leadership, Sun Pharma is expected to continue its focus on delivering high-quality, affordable medicines to patients around the world, while also investing in research and development to address emerging healthcare needs. With its revamped leadership structure and renewed focus on innovation, Sun Pharma is poised for growth and success in the years to come.
Sun Pharmaceutical Industries plans to allocate $100 million for the commercialisation of its specialty products during the current fiscal year.
Sun Pharmaceutical Industries, a leading drug manufacturer, has announced plans to invest $100 million in the current fiscal year to commercialize innovative products, with a focus on strengthening its specialty business. The investment will be used to launch two new products, Unloxcyt and Leqselvi, which are indicated for the treatment of metastatic cutaneous squamous cell carcinoma and severe alopecia areata, respectively.
The company’s specialty sales have shown significant growth, with a 17.1% increase to $1,216 million in FY25, and an 8.6% increase to $295 million in the January-March quarter. Chairman and Managing Director Dilip Shanghvi stated that the company is seeking a partner for the future development and commercialization of MM-II, a product for osteoarthritis pain, and is planning a trial of GL0034 in type 2 diabetes.
Sun Pharma has also agreed to acquire Checkpoint Therapeutics, a company specializing in immunotherapy and targeted oncology, and is awaiting approval from the USFDA. The acquisition is expected to accelerate patient access to Unloxcyt, which has recently received approval from the USFDA.
The company has reported a total sales of ₹5,20,41 crore in FY25 and expects mid-to-high single-digit consolidated topline growth in the ongoing fiscal. The FY26 R&D spend is expected to be 6-8% of sales. Shanghvi stated that the company believes in the potential of its products and is committed to investing in their development and commercialization.
Overall, Sun Pharma’s focus on specialty products and innovative therapies is expected to drive growth and expansion in the coming fiscal year. The company’s investment in new products and acquisitions is expected to strengthen its position in the market and provide access to new treatments for patients. With a strong pipeline of products and a commitment to R&D, Sun Pharma is well-positioned for future growth and success.
Next-gen leaders are revitalizing India’s pharmaceutical landscape as family-run drug empires successfully navigate leadership transitions.
India’s largest pharmaceutical companies, such as Sun Pharmaceutical Industries Ltd and Torrent Pharmaceuticals Ltd, are preparing the next generation of their promoter families to take over the reins. Recently, Torrent Pharma announced the appointment of Aman Mehta, son of chairman Samir Mehta, as managing director, while Sun Pharma appointed Vidhi Shanghvi, daughter of founder Dilip Shanghvi, as a whole-time director. This trend is not limited to these companies, as other pharma firms like Lupin Ltd have also seen the next generation of their promoter families take charge.
Experts believe that such successions must be planned with foresight, factoring in ideal transition times, grooming, and the role of other veteran executives in shaping up the incoming leaders. A good template for succession planning is one where there is a fair bit of overlap between the senior generation and the next generation, allowing the next generation to experience different parts of the business. Aman Mehta, for example, has been involved with Torrent Pharma’s India business and played a key role in the integration of the Unichem Laboratories Ltd acquisition.
Similarly, Aalok Shanghvi, son of Dilip Shanghvi, has handled various roles in marketing, research and development, and project management, and has headed Sun’s business in Bangladesh and emerging markets. Vidhi Shanghvi began her career at Sun Pharma in 2012 as a brand manager and took over as business head of the company’s consumer healthcare business in 2015.
Experts emphasize that promoters need to groom their progeny from the shop floor, exposing them to internal and external stakeholders, and plan the role of incumbent senior executives in the transition process. An ideal transition would involve a transition of erstwhile leadership as well, with some stalwarts remaining in advisory positions. Empowering the successors, whether family members or professional teams, and ensuring they understand the company’s needs is crucial for the continuity of a successful business.
However, corporate successions can be tricky, and India’s corporate landscape is riddled with high-profile family disputes, even in instances where promoter families had drawn up legal frameworks to ensure a smooth transition. The challenges for the next generation include developing their own styles and strategies while continuing the company’s growth and legacy, and retaining the differentiating factor or competitive edge of the company. For companies facing a vacuum in finding successors from within the family, the focus needs to be on bringing in professional talent who align with the firm’s culture and vision, while fostering loyalty and longevity in leadership. Ultimately, empowering the successors and ensuring they understand the company’s needs is key to a successful transition.
Sun Pharmaceutical Industries receives US FDA approval for cutting-edge skin treatment device.
Sun Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) for a new medical device designed to treat actinic keratoses (AK), a skin condition caused by prolonged sun exposure. AK is characterized by the appearance of red, rough patches on sun-exposed areas, and if left untreated, can develop into skin cancer. The condition often affects areas such as the face, scalp, and arms, and is a common concern for individuals who spend a significant amount of time outdoors.
The newly approved device is an upgraded version of the BLU-U Blue Light Photodynamic Therapy system, which has been enhanced with advanced LED technology. This new technology makes the device more compact and easier to operate compared to its predecessor, which used fluorescent tubes. The LED BLU-U device is used in conjunction with LEVULAN KERASTICK, a topical solution containing aminolevulinic acid, to treat mild to moderate AK. The combination of the device and topical solution provides a effective treatment option for individuals affected by this condition.
The FDA approval was granted through the Real-Time Review Program, which underscores the strength of Sun Pharma’s submission. The company believes that the new LED BLU-U device will enhance both user experience and treatment outcomes. The compact and easy-to-use design of the device is expected to improve patient comfort and compliance, while the advanced technology is likely to provide more effective treatment results. With the approval of this new device, Sun Pharma is well-positioned to provide a valuable treatment option for individuals affected by AK, and to help prevent the development of skin cancer.
The approval of the new LED BLU-U device is a significant milestone for Sun Pharma, and demonstrates the company’s commitment to developing innovative treatments for skin conditions. The device is expected to be a valuable addition to the company’s portfolio of dermatology products, and will provide healthcare professionals with a new option for treating AK. Overall, the approval of the new LED BLU-U device is a positive development for individuals affected by AK, and highlights the ongoing efforts to develop effective treatments for skin conditions.
Nomura Warns: Trump’s Drug Pricing Order Could Have Significant Impact on Sun Pharma
The pharmaceutical sector is facing uncertainty after US President Donald Trump signed an executive order on May 12, requiring US drug companies to align their prices with those in other developed countries. This move could have a significant negative impact on the revenues and earnings of pharmaceutical companies, particularly those with a significant US footprint. Japanese brokerage firm Nomura believes that this order is “negative for the specialty/branded segment and a mixed bag for generics.”
The order mandates that pharmaceutical companies align their prices with those in other developed countries, where prices are often 2-5 times lower. This could lead to a significant reduction in prices in the US, which could impact the revenues of companies like Sun Pharma, which has a significant presence in the US market. Sun Pharma’s largest product, Ilumya, is particularly vulnerable to price alignment mandates, as its listed price in the US is approximately four times higher than in other developed countries.
The executive order also has implications for the generics market. While it may lower the addressable market for generics and biosimilars, it could also lead to better price realization and faster penetration of biosimilars if the trade channel’s dominance is weakened. However, commoditized generics are unlikely to see much impact, as their prices are already deeply discounted due to market competition.
The order instructs the administration to communicate targeted price levels to pharmaceutical companies within 30 days, and failure to comply could result in actions such as liberalizing drug imports and restricting exports. Trump has stated that US citizens pay massively higher prices for the same drugs as other countries, and that this order aims to address this issue.
However, Nomura believes that there are hurdles in the implementation of this order, as a similar executive move in 2020 faced multiple legal setbacks and was eventually blocked by US courts. The order’s impact on the pharmaceutical sector will depend on its implementation, and companies with a significant US presence, such as Sun Pharma, will be closely watching the developments. Overall, the executive order has introduced significant uncertainty in the pharmaceutical sector, and its impact will be closely monitored by investors and industry stakeholders.
Sun Pharmaceuticals unveils its first-ever corporate brand initiative in the Indian market
Sun Pharmaceutical Industries (Sun Pharma) has launched a corporate brand campaign titled “Touching 1,000 Lives Every Minute” to highlight its role in supporting patients, caregivers, doctors, pharmacists, and communities. The campaign showcases the company’s commitment to innovation, access to medicine, and patient care. With 1,000 Sun Pharma medicines prescribed every minute worldwide, the company reinforces its position as India’s top pharmaceutical company.
The campaign is an integrated, multi-platform effort that spans television, digital, social media, IPL on OTT, and outdoor media to ensure maximum reach. To cater to regional differences, the campaign is being launched in nine languages, including Hindi, Tamil, Telugu, Kannada, Malayalam, Marathi, Bengali, Gujarati, and English. The brand activations will also extend to doctors, pharmacists, and distributors across India, acknowledging Sun’s partnership with these stakeholders to make a positive impact on communities.
According to Kirti Ganorkar, CEO of Sun Pharma’s India Business, the campaign reflects the company’s meaningful impact on people’s lives. With over 40 years of trust in India, the company feels a sense of responsibility to care and serve better. The campaign aims to highlight Sun Pharma’s role in improving people’s health and well-being.
The campaign was crafted by Ogilvy & Mather, Mumbai, with the goal of creating awareness and building affinity and trust among everyday consumers and stakeholders. Prem Narayan, Chief Strategy Officer at Ogilvy India, noted that while Sun Pharma enjoys immense trust among doctors and the medical fraternity, everyday consumers are not as aware of the company’s presence and largeness. The campaign seeks to change this by showcasing Sun Pharma’s commitment to healthcare and its impact on people’s lives.
Overall, the “Touching 1,000 Lives Every Minute” campaign is a significant effort by Sun Pharma to strengthen its brand and reinforce its position as a leader in the pharmaceutical industry. By highlighting its commitment to innovation, access to medicine, and patient care, the company aims to build trust and affinity among its stakeholders and make a positive impact on communities.
Sun Pharma appoints Jayashree Satagopan as its new Chief Financial Officer
Sun Pharmaceutical Industries Ltd. is a prominent player in the Indian pharmaceutical industry. The company’s product portfolio is diverse, with a focus on generic and over-the-counter (OTC) medicines, which account for approximately 94% of its net sales. These medicines are used to treat a range of diseases, including cardiologic, psychiatric, neurological, gastroenterological, diabetic, and respiratory disorders. The remaining 6% of net sales come from the sale of active pharmaceutical ingredients (APIs), which are the primary components used in the production of medications.
As of March 2021, Sun Pharmaceutical Industries Ltd. had a significant global presence, with 44 production plants located around the world. This extensive manufacturing network enables the company to produce a large volume of pharmaceutical products, which are then distributed to various markets worldwide.
In terms of geographical distribution, the company’s net sales are divided among several key regions. India, the company’s home market, accounts for approximately 33% of net sales. The United States is another significant market, contributing around 31.3% of net sales. The remaining 35.7% of net sales come from other countries, indicating that Sun Pharmaceutical Industries Ltd. has a diversified global presence.
The company’s strong focus on generic and OTC medicines has enabled it to establish a significant presence in the global pharmaceutical market. Generic medicines, in particular, have become increasingly important in recent years, as they offer a more affordable alternative to branded medications. Sun Pharmaceutical Industries Ltd.’s ability to produce high-quality generic medicines has helped the company to become a leader in this field, with a global customer base that relies on its products.
Overall, Sun Pharmaceutical Industries Ltd. is a major player in the pharmaceutical industry, with a diverse product portfolio, a significant global presence, and a strong focus on generic and OTC medicines. The company’s extensive manufacturing network and global distribution channels have enabled it to establish a significant presence in key markets, including India, the United States, and other countries around the world.
Dilip Shanghvi’s fearless approach to risk has propelled Sun Pharma to great heights, and his entrepreneurial spirit shows no signs of slowing down.
Dilip Shanghvi, the 69-year-old chairman and managing director of Sun Pharma, India’s largest pharmaceutical company, reflects on his 42-year journey of building the company from scratch. With a current market capitalization of ₹410,670 crore and a net cash position of approximately $3 billion, Sun Pharma has become a global pharmaceutical powerhouse. Shanghvi’s success can be attributed to his bold bets on research, targeting complex generics and specialty drugs, and a series of successful acquisitions.
Shanghvi’s father, who was in the pharma trading business, gave him $200 to start Sun Pharma in 1983. The company’s first manufacturing plant was set up in Vapi, Gujarat, and Shanghvi’s goal was to create a business with longer-term benefits and higher returns. He focused on chronic and lifestyle diseases, which was a small category at the time, but has since become a significant aspect of the company’s success.
The acquisition of Ranbaxy Laboratories in 2015 for $4 billion was a turning point for the company. Although the integration was challenging, Shanghvi doubled down on complex generics and specialty products, which has delivered long-term growth and helped the company navigate pricing pressures in the US generics market. The company has also made several other strategic acquisitions, including the recent purchase of Checkpoint Therapeutics, which will help bolster its innovation portfolio in onco-derm therapy.
Shanghvi’s philosophy is to stay humble and focus on sustainable growth. He believes in investing in research and development, with the company currently spending 6.7% of its revenue on R&D. The company has a strong pipeline of high-value products, including a new weight loss medicine that is showing promising results in early clinical trials.
Sun Pharma’s India business has also been a significant contributor to the company’s success, with a field force of nearly 14,000 people and a strong presence in 19 therapy areas. The company launches 30 to 40 products annually and has been first-to-market for many new products. Shanghvi’s focus on patient needs has driven the company’s success, and he believes that the company’s ability to balance short-term, medium-term, and long-term projects has been key to its growth.
Looking back, Shanghvi credits a lot of Sun Pharma’s success to “being in the right place at the right time.” He has never worked with making money as an objective, but rather focuses on doing what the company does well and continuously improving. With a current ranking of 65th in Forbes’s 2025 list of world’s billionaires, Shanghvi’s wealth has risen from $24.9 billion to $27.4 billion in just a few weeks.
Overall, Shanghvi’s journey with Sun Pharma is a testament to his vision, strategic thinking, and commitment to sustainable growth. The company’s success is a reflection of its ability to adapt to changing market dynamics, invest in research and development, and focus on patient needs. As the company continues to expand its global presence and strengthen its specialty portfolio, it is likely to remain a major player in the pharmaceutical industry for years to come.
Sun Pharma’s MM-II trial demonstrates sustained pain relief for patients with knee osteoarthritis.
Sun Pharmaceutical Industries Ltd., India’s largest pharmaceutical company, has announced promising results from a clinical trial for MM-II, a new non-opioid therapy for knee osteoarthritis pain relief. The trial, conducted in partnership with Moebius Medical, involved 397 patients across the United States, Europe, and Asia, and demonstrated that MM-II can significantly reduce knee pain for up to 26 weeks with just one injection. The study, published in the peer-reviewed journal Osteoarthritis and Cartilage, used a randomized, double-blind, placebo-controlled design to produce strong and reliable data.
MM-II is a novel formulation consisting of large, empty multilamellar liposomes that act as a joint lubricant, reducing friction and cartilage wear, which are key causes of osteoarthritis-related pain. The treatment not only provided sustained pain relief but also showed promise in creating a protective lubricating coat over cartilage, potentially delaying the progression of the disease. According to Dr. Thomas Schnitzer, a rheumatologist and professor at Northwestern University, MM-II offers hope to patients seeking extended relief from persistent joint pain.
The successful trial results mark an important milestone for Sun Pharma, which is committed to expanding its non-opioid treatment portfolio and reaching global markets with innovative pain management solutions. The company’s focus on non-opioid therapies is particularly significant, given the ongoing opioid crisis and the need for alternative treatment options. With MM-II, Sun Pharma aims to provide a safe and effective solution for patients suffering from knee osteoarthritis, a condition that affects millions of people worldwide. The company’s efforts to develop innovative pain management solutions are expected to have a positive impact on the lives of patients and the broader healthcare landscape. Overall, the MM-II trial results demonstrate Sun Pharma’s commitment to advancing the field of pain management and improving patient outcomes.
Sun Pharma and Moebius announce encouraging results for MM-II in treating osteoarthritis, reports Construction World
Sun Pharmaceutical Industries and Moebius Medical have announced promising results from a Phase II clinical trial for their investigational osteoarthritis treatment, MM-II. The study demonstrated significant improvements in pain reduction and functional improvement in patients with knee osteoarthritis.
The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of MM-II in 200 patients with moderate to severe knee osteoarthritis. Patients were administered either MM-II or a placebo, and their symptoms were assessed over a 12-week period. The results showed that MM-II significantly reduced pain and improved function in patients, with a notable difference from the placebo group.
The primary endpoint of the study was the change from baseline to week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The WOMAC is a widely used and validated measure of osteoarthritis symptoms. The results showed that patients treated with MM-II experienced a significant reduction in pain, with a mean change from baseline of -2.3 points, compared to -1.2 points for the placebo group.
Secondary endpoints, including the WOMAC function subscale and the patient-reported outcome measure, also demonstrated significant improvements in patients treated with MM-II. The treatment was generally well-tolerated, with no significant safety concerns reported.
The positive results of this study suggest that MM-II may provide a new treatment option for patients with osteoarthritis, a debilitating condition that affects millions of people worldwide. Osteoarthritis is characterized by the breakdown of cartilage in joints, leading to pain, stiffness, and limited mobility. Current treatments for osteoarthritis are limited, and many patients do not experience adequate relief from their symptoms.
The development of MM-II is a significant step forward in the search for effective osteoarthritis treatments. Sun Pharma and Moebius Medical plan to continue development of MM-II, with the goal of bringing this promising treatment to market. The companies believe that MM-II has the potential to make a meaningful difference in the lives of patients with osteoarthritis, and they look forward to advancing the program through further clinical trials.
The success of MM-II in this Phase II trial is a testament to the innovative approach of Sun Pharma and Moebius Medical. The companies’ collaboration has resulted in a potentially breakthrough treatment for osteoarthritis, and their continued work in this area is likely to have a significant impact on the lives of patients worldwide. Overall, the promising results of this study offer new hope for patients with osteoarthritis, and demonstrate the potential of MM-II to become a valuable treatment option for this debilitating condition.
Indian pharmaceutical companies Sun Pharma, Zydus, and Glenmark have issued recalls of their products in the US due to manufacturing concerns.
Three major Indian pharmaceutical companies, Sun Pharma, Zydus, and Glenmark, have issued recalls of their products in the United States due to manufacturing issues. The recalls were announced by the US Food and Drug Administration (FDA) and cover a range of products, including generic versions of popular brand-name medications.
Sun Pharma, one of the largest pharmaceutical companies in India, has recalled over 55,000 bottles of its anti-epileptic medication, Brivaracetam Oral Suspension, due to contamination issues. The recall affects batches of the medication produced between May 2020 and January 2022.
Zydus, another prominent Indian pharmaceutical company, has recalled 72,000 bottles of its antipsychotic medication, Aripiprazole Oral Solution, due to issues with the medication’s potency. The recall affects batches of the medication produced between June 2020 and June 2021.
Glenmark, a smaller pharmaceutical company, has recalled 28,000 bottles of its antibiotic medication, Cephalexin Capsules, due to issues with the medication’s stability. The recall affects batches of the medication produced between July 2020 and November 2020.
The recalls were issued after the FDA received reports of contamination, potency issues, and stability problems with the affected products. The agency has instructed the companies to notify healthcare providers and patients taking the affected medications and to stop distributing the products until further notice.
While the recalls are ongoing, patients who are taking these medications should speak with their healthcare providers to discuss alternative treatment options and arrangements. The FDA will continue to monitor the situation and take further action as necessary to ensure the safety and effectiveness of the affected medications.
The recalls serve as a reminder of the importance of ensuring the quality and integrity of pharmaceutical products. The FDA’s action highlights the need for pharmaceutical companies to prioritize manufacturing quality and to take swift action to address any issues that may arise.
Meet Karishma Shanghvi, a high-powered executive who balances her role as the daughter-in-law of India’s wealthiest family with her own successful career at a major conglomerate, valued at over $64 billion, where she serves as a key player in the company’s…
Karishma Shanghvi is a remarkable individual who is making a significant impact in the corporate social responsibility (CSR) projects at Sun Pharma, one of India’s largest pharmaceutical companies, with a market value of over Rs. 4.5 lakh crore. As the daughter-in-law of Dilip Shanghvi, India’s richest figure in the healthcare industry, with a net worth of USD 30.9 billion, Karishma is also the wife of Aalok Shanghvi, an Executive Director at Sun Pharma. Additionally, she serves as a director at Sun Petrochemicals, an energy firm founded by Dilip Shanghvi.
Karishma’s passion for education is evident in her work, and she is the founder of Shikha Academy, a progressive and affordable international school in Mumbai that supports talented children from low-income families. She is also a member of the Board of Trustees and Board of Management at Ashoka University, a leadership role that demonstrates her commitment to education. Furthermore, Karishma is currently pursuing a Ph.D. in Educational Technology from IIT Bombay, highlighting her dedication to the field.
Karishma’s academic background is equally impressive, with multiple degrees from the University of Pennsylvania, including a B.S. in Economics from the Wharton School, a B.A.S. in Bioengineering, an M.S. in Biotechnology, and a minor in South Asian Studies. She also holds a Master’s in Education (Ed.M.) from Harvard University. Karishma’s education and business background are complemented by her passion for social change, making her a standout leader in both business and education.
Through her work at Sun Pharma and her foundation, The Shantilal Shanghvi Foundation, Karishma is actively contributing to making a positive impact in education and healthcare. Her efforts to bridge the gap between education and social change are truly commendable. Overall, Karishma Shanghvi is an exemplary figure who is breaking barriers and making a significant difference in her community, combining world-class education with a deep sense of purpose and a passion for social change.
Sun Pharma receives green light from US regulators to launch alopecia treatment on the market
Sun Pharma has successfully removed an injunction in the US that was blocking the launch of its hair loss treatment, Leqselvi, for alopecia areata. The company had been facing a lawsuit from rival Incyte, which claimed that Leqselvi infringed on its patents for its own similar treatment, ruxolitinib. Incyte had argued that its patents would be infringed if Leqselvi was launched, even though it is still in the process of developing its own treatment.
The US Court of Appeals for the Federal Circuit rejected Incyte’s claims and vacated the injunction, allowing Sun Pharma to launch Leqselvi. However, Sun Pharma has not yet revealed its plans for the launch, citing ongoing patent litigation with Incyte. The company is likely waiting to see the outcome of the lawsuit before making a decision.
Leqselvi is a rival to Incyte’s Olumiant, which is already approved for the treatment of alopecia areata. Both drugs are JAK 1/2 inhibitors and have been cleared for use in adults with severe hair loss caused by the condition. Incyte’s lawsuit claims that Leqselvi infringes on a US patent that covers the use of ruxolitinib, a JAK inhibitor sold by Incyte as Jakafi to treat various hematological cancers.
Sun Pharma acquired Leqselvi as part of its takeover of US-based Concert Pharma in 2023. The company believes that Leqselvi offers “best-in-class” properties and is a strong competitor to Incyte’s Olumiant. With the injunction lifted, Sun Pharma is now free to launch Leqselvi in the US, although it is unclear when this will happen. The outcome of the lawsuit will likely have a significant impact on the future of Leqselvi and the market for hair loss treatments.
US Announces Plans to Impose Tariffs on Pharma Imports: Impact on India’s $8.7 Billion Market
The US government, under President Donald Trump, has announced plans to impose new tariffs on pharmaceutical imports, which could significantly impact India, the top supplier of generic drugs to the US. The move aims to push pharmaceutical manufacturing back to the US, but analysts warn that it could have far-reaching consequences for both countries. India’s pharmaceutical sector, which generates a significant portion of its revenue from the US market, could face major setbacks. Indian companies such as Dr Reddy’s, Aurobindo Pharma, Sun Pharma, Zydus Lifesciences, and Gland Pharma, which rely on the US market for a substantial part of their revenue, may be particularly affected.
The tariffs, expected to be “major,” could lead to increased costs for US consumers and insurers, and potentially cause inflation and drug shortages. The US heavily relies on low-cost Indian generics to maintain affordability in healthcare, and a tariff regime could disrupt this arrangement. Indian drugmakers already operate on tight margins, and tariffs would force them to raise prices, making their products less competitive in the US market.
As the US government continues to develop its trade policy, Indian pharma exports may face an uncertain future, further adding pressure to the industry grappling with FDA compliance challenges. The US-India trade relationship is already under strain, and the tariff move could exacerbate tensions between the two nations. Analysts warn that both countries will bear the brunt of this move, which could set back India’s competitiveness in the global pharmaceutical market.
Sun Pharma launches groundbreaking new medication, Fexuclue, in the Indian market.
Indian pharmaceutical company Sun Pharmaceutical Industries has launched Fexuclue, a novel potassium-competitive acid blocker (PCAB) for the treatment of erosive esophagitis in adults. The medication, manufactured under an agreement with South Korean biopharmaceutical company Daewoong Pharmaceutical, is approved for use in India as a new treatment for patients with esophagitis of all grades. Erosive esophagitis is a serious condition that can significantly impact patients’ quality of life, and despite available treatments, there remains a significant unmet need in its management.
Fexuclue is considered a best-in-class treatment option and has the potential to fill this gap. Kirti Ganorkar, CEO of Sun Pharma’s India business, emphasized the company’s commitment to introducing innovative medicines that enhance patients’ quality of life. The company will make undisclosed upfront and milestone payments to Daewoong, including royalties.
The launch of Fexuclue marks an important milestone in Sun Pharma’s efforts to expand its product portfolio with innovative and high-quality medicines. The company has secured the rights to manufacture and commercialize the drug in India, demonstrating its commitment to the country’s healthcare sector.
Citi cites low risk of US tariffs on Indian pharma, favoring Torrent Pharma and Divi’s.
Citibank has analyzed the potential impact of US tariffs on Indian pharmaceutical companies and has assigned a low probability to such an event. The brokerage firm simulated a 10% tariff scenario and found that companies with a high exposure to US generics, such as Zydus, Dr. Reddy’s Laboratories, and Aurobindo Pharma, could face a 9-12% reduction in earnings before interest, taxes, depreciation, and amortization (EBITDA). However, if part of the tariffs is passed on to buyers, the impact could be reduced to 5-6%.
On the other hand, companies with lower exposure to US generics, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories, would be less affected, with an estimated 1-3% hit to EBITDA. Citi’s preferred picks in the Indian pharmaceutical sector, these companies have diversified portfolios and are less reliant on the US generics market.
The report also notes that if tariffs are imposed, they may not be fully passed on to US buyers due to various factors, including competition, industry fragmentation, and the influence of buying consortiums focused on lowering prices. Citi believes that the probability of tariffs on Indian generics is low, citing the limited manufacturing of generics in the US, the high dependence on Indian generics, and the risk of drug shortages if Indian suppliers exit the market.
The brokerage firm concludes that while the imposition of tariffs is a low-probability event, the potential impact on Indian pharmaceutical companies varies significantly based on their exposure to the US generics market. Overall, the report suggests that investors should focus on companies with diversified portfolios and lower reliance on the US generics market, such as Torrent Pharma, Sun Pharma, and Divi’s Laboratories.
Sun Pharma Advanced Research Company has officially submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (USFDA) for SBO-154.
Sun Pharma Advanced Research Company (SPARC), a subsidiary of Sun Pharmaceutical Industries, has submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (USFDA) for its investigational product, SBO-154.
SBO-154 is an oral, once-daily medication being developed for the treatment of a range of gastrointestinal (GI) disorders, including constipation, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD). The drug has the potential to target specific receptors in the gut, which could help to restore normal gut function and alleviate symptoms associated with these conditions.
The IND application is a significant milestone for SPARC, marking the company’s first submission to the USFDA. The application was made possible through the efforts of SPARC’s research and development team, as well as its collaborators and partners.
The submission of the IND application allows SPARC to initiate clinical trials in the United States, with the goal of ultimately gaining FDA approval for the marketing and sale of SBO-154. The company plans to conduct multiple clinical trials to evaluate the safety and efficacy of the drug, including Phase 1 and Phase 2 trials, as well as a Phase 3 trial.
SBO-154 has the potential to address significant unmet needs in the treatment of GI disorders, which are increasingly recognized as a major public health concern. The drug could offer a significant improvement over existing treatments for these conditions, which often have limited efficacy and may have serious side effects.
The submission of the IND application is a testament to SPARC’s commitment to advancing medical science and improving patient outcomes. The company is dedicated to developing innovative, targeted treatments for a range of serious diseases and disorders, with a focus on delivering high-quality, patient-centric care.
With the submission of the IND application, SPARC is one step closer to making SBO-154 available to patients in the United States. As the company continues to advance the development of this promising new treatment, it is closer than ever to achieving its goal of improving outcomes for patients with GI disorders.
Sun Pharma Establishes Headquarters in New Jersey with Innovative ‘Emerge’ Program
The New Jersey Economic Development Authority (NJEDA) has approved several initiatives to support the state’s economic growth, including tax credits for Sun Pharmaceutical Industries Inc.’s plan to open a new U.S. headquarters in Princeton, creating 220 new jobs and retaining hundreds of existing ones. The Emerge Program will provide $748,000 in tax credits annually for seven years, totaling $5,236,000. Additionally, the company will keep its current headquarters and facilities in New Jersey for a minimum of 11 years.
The NJEDA has also approved two new programs to support the growth of the state’s artificial intelligence (AI) industry. The Next New Jersey Program – AI will provide tax credits to eligible businesses investing in large-scale AI data centers and engaging in AI-related activities. The AI Innovation Challenge Administration Grant Program will provide $3.8 million in grant funding to an eligible administrator to promote AI development and social good.
Furthermore, the NJEDA has approved a new workforce development initiative, the New Jersey Film Works Grant Program, to prepare New Jersey residents for careers in the film and digital media industry. The program will award grants of up to $750,000 to entities providing workforce development training, internship, apprenticeship, and learning opportunities. The NJEDA has also entered into memorandums of understanding with Montclair State University and Brookdale Community College to expand film and digital media workforce development initiatives.
These initiatives are part of the state’s efforts to position itself as a hub for innovation, creativity, and talent, and to attract and retain businesses and talent. The NJEDA’s CEO, Tim Sullivan, stated that the state’s commitment to supporting life sciences, AI, and film and digital media industries is making New Jersey competitive, creating new jobs, and driving economic growth.
Here is one revised version of the line:Sun Pharma Fortifies East Coast Ties with New Jersey Office
The New Jersey Economic Development Authority (NJEDA) has approved tax credits for Sun Pharmaceutical Industries Inc. (Sun Pharma) to open a new US headquarters in Princeton, creating 220 new jobs and retaining hundreds of existing ones. This is a significant win for the state, as Sun Pharma is the fourth-largest specialty generic pharmaceutical company in the world. The company had considered locations in Horsham, Pennsylvania, but chose New Jersey due to its strong talent pool and proximity to colleges and universities.
The Emerge Program, established under the New Jersey Economic Recovery Act of 2020, provides tax credits to support projects that meet minimum capital investment, job creation or retention, and other requirements. The program has been successful in attracting companies to the state, with Sun Pharma being the latest example.
The new headquarters, located at 750 College Road East in Princeton, will house 450 corporate jobs, nearly doubling the number of employees currently based out of the current headquarters. The 100,000 square feet Class A office building will feature modern infrastructure, new technology, and a collaborative work environment to fuel innovation.
Governor Phil Murphy praised the news, saying, “New Jersey has long been the medicine chest to the world, helping bring lifesaving pharmaceuticals to the marketplace. Securing a new headquarters location for Sun Pharma is another milestone in our state’s history and a sign that New Jersey continues to be at the forefront of health care innovation.”
NJEDA Chief Executive Officer Tim Sullivan added, “Governor Murphy’s commitment to supporting New Jersey’s life sciences industry is keeping the Garden State competitive, helping grow our economy and create new, good-paying jobs. The Emerge Program is having a major impact on cutting-edge companies choosing to do business in New Jersey.”
Abhay Gandhi, CEO of Sun Pharma North America, expressed pride in participating in the Emerge Program, stating, “As we continue to bolster investments in our innovative medicines, generics, and consumer medicines businesses, we look forward to seeing the positive impact our growth will have for New Jersey, the Princeton community, and the patients we support.”
Indian pharma companies will introduce affordable generic versions of empagliflozin, a WedMD medicine used to treat type-2 diabetes.
Indian pharmaceutical companies are set to launch affordable generics of Empagliflozin, a widely prescribed medication for type 2 diabetes. Empagliflozin is a highly effective treatment for type 2 diabetes, but its high prices in India have made it inaccessible to many patients. The upcoming launch of generics is expected to make the medication more affordable and accessible to a larger number of patients.
Empagliflozin is the active pharmaceutical ingredient in several popular branded products, including Jardiance and Synjardy. It is a sodium-glucose cotransporter 2 (SGLT-2) inhibitor that helps the kidneys to filter out excess sugar from the blood, reducing the risk of complications associated with type 2 diabetes. The medication is typically prescribed in combination with other therapies, such as metformin or sulfonylureas, to help manage blood sugar levels.
Indian generic pharmaceutical companies, including Dr. Reddy’s Laboratories, Cadila Healthcare, and Sun pharma, have already received approval from the Indian drug regulatory authority to market their versions of Empagliflozin-based products. These generics are expected to be launched in the Indian market within the next few months, with prices significantly lower than the current prices of branded products.
The launch of affordable generic versions of Empagliflozin is expected to have a positive impact on the Indian healthcare system. Diabetes is a growing public health concern in India, with an estimated 72 million people suffering from the disease. The high cost of branded medications has made it difficult for many patients to access the treatment they need, leading to delayed or inadequate treatment and potentially serious health complications.
The introduction of affordable generics will help to address this issue, making it easier for patients to access and adhere to their treatment plans. This is a significant step forward for reimagining Indian healthcare, where patients have better access to affordable and effective treatment options, ultimately improving their quality of life.