Dr. Reddy’s excels in generics, biosimilars, and active pharmaceutical ingredients (APIs), with a portfolio spanning therapeutic areas like gastroenterology, oncology, cardiovascular, and pain management. It invests heavily in R&D (8-15% of sales annually), driving innovation and securing exclusive generic drug approvals, such as 180-day exclusivity in the U.S. market. Strategic acquisitions, like Trigenesis Therapeutics and UCB SA’s brands, and partnerships, such as with Alvotech for biosimilars, enhance its global footprint and product offerings.
Financially, Dr. Reddy’s reported ₹31,229 crore in revenue and ₹5,448 crore in profit for FY2024, with a market cap of ~₹98,132 crore. Despite fluctuating net profit margins (7-20% over FY2015-FY2024), its integrated supply chain, regulatory expertise, and focus on high-growth areas like nutraceuticals and cell therapy position it for sustained growth. However, challenges include regulatory hurdles, competition in generics, and ethical criticism for continued operations in Russia.
Latest News on Dr. Reddy’s Laboratories
Delhi High Court Bars Dr. Reddy’s and OneSource From Promoting Novo Nordisk’s Weight Loss Medication
The Delhi High Court has issued an interim order restricting Indian companies, Reddy’s Laboratories and OneSource Specialty Pharma, from marketing semaglutide, the active ingredient in the weight loss drug Wegovy, in India. The order was made in response to a patent infringement lawsuit filed by Danish pharmaceutical company Novo Nordisk, which claims that the Indian companies’ actions constitute a violation of their patent rights. Semaglutide is a key component of Novo Nordisk’s weight loss drug Wegovy, and the company is seeking to protect its intellectual property.
During the court proceedings, the Indian companies acknowledged that they had been granted a license to manufacture semaglutide in December 2024 and had begun production in April 2025. However, they claimed that they did not have a license to sell the drug in India and assured the court that they would not do so. Instead, they reserved the right to export the drug to countries where Novo Nordisk does not hold a patent.
Novo Nordisk’s counsel argued that exporting an infringing product also constitutes patent infringement under the Patents Act, 1970. The court has accepted this argument and issued an order restricting the Indian companies from selling semaglutide in India. The matter is scheduled to be heard again on August 19, 2025, and the Indian companies have been granted 30 days to file their written statements in response to Novo Nordisk’s lawsuit.
The case highlights the complexities of patent law and the challenges faced by pharmaceutical companies in protecting their intellectual property rights. Novo Nordisk’s lawsuit demonstrates the company’s efforts to safeguard its patent rights and prevent unauthorized use of its proprietary technology. The outcome of the case will have significant implications for the pharmaceutical industry and the availability of affordable medicines in India. The court’s decision will also set a precedent for future patent infringement cases in India, particularly in the context of pharmaceutical products.
Tough Road Ahead for Dr Reddy’s as DTAB and CDSCO Propose Strict Curbs on Nimesulide
The Indian pharmaceutical company, Dr. Reddy’s Laboratories, is facing a challenging time due to regulatory issues surrounding one of its key products, Nimesulide. The Drug Technical Advisory Board (DTAB) and the Central Drugs Standard Control Organization (CDSCO) have recommended stringent restrictions on the use of Nimesulide, a non-steroidal anti-inflammatory drug (NSAID).
Nimesulide is a widely used medication for pain and inflammation management, and Dr. Reddy’s is one of the leading manufacturers of the drug in India. However, concerns have been raised about the safety of Nimesulide, particularly in children, due to reports of adverse effects such as liver toxicity and bleeding. The DTAB and CDSCO have taken a stern view of these concerns and have recommended that Nimesulide be banned for use in children below the age of 12 years.
Furthermore, the regulatory bodies have also recommended that Nimesulide be sold only under prescription and with a warning label highlighting the potential risks associated with its use. The recommended restrictions are likely to have a significant impact on Dr. Reddy’s sales of Nimesulide, which is a major contributor to the company’s revenue.
The recommendations of the DTAB and CDSCO are based on a review of available data and evidence, including reports of adverse events and studies on the safety and efficacy of Nimesulide. The regulatory bodies have also taken into account the views of medical experts and stakeholders in the pharmaceutical industry.
Dr. Reddy’s has not commented on the recommendations, but the company is likely to be concerned about the potential impact on its business. The company may need to re-strategize its marketing and sales plans for Nimesulide and explore alternative products to mitigate the potential losses. The recommendations of the DTAB and CDSCO are also likely to have implications for other pharmaceutical companies that manufacture and market Nimesulide in India.
The development highlights the importance of regulatory oversight in ensuring the safety and efficacy of pharmaceutical products. The Indian regulatory authorities have been taking a proactive approach to addressing concerns about the safety of various drugs, and the recommendations on Nimesulide are part of this effort. The move is expected to have a positive impact on public health, but it may have significant commercial implications for Dr. Reddy’s and other companies involved in the manufacture and sale of Nimesulide.
Dr Reddy’s Maintains Nimesulide’s Safety Profile Amidst Looming Ban On High-Dose Versions Above 100mg
The Indian Council of Medical Research (ICMR) has recommended that all formulations of the painkiller Nimesulide above 100 milligrams should be banned due to its poor safety profile. The recommendation comes after a report by ICMR, which was requested by the Drugs Technical Advisory Board (DTAB), highlighted the adverse effects of the drug, particularly on the liver. The report suggests that Nimesulide should be reserved only as a second-line treatment and used only after all first-line options have been tried and found ineffective.
The DTAB has also recommended that oral formulations of Nimesulide above 100 mg in “immediate release dosage form” should be prohibited, and its use should be restricted among vulnerable groups such as children under 12, adults over 60, pregnant and lactating women, and people with kidney or liver diseases. However, the recommendations are yet to be approved by the Drug Controller General of India (DCGI).
Dr. Reddy’s Laboratories, the largest seller of branded Nimesulide under the name ‘Nise’, has responded to the recommendations by stating that robust research and clinical trials have consistently established the safety and efficacy of Nimesulide when used as prescribed. The company clarified that it does not sell the drug in doses above 100 mg and that its prescribing information specifies that Nimesulide is indicated for short-term treatment and not exceeding more than 10 days.
Dr. Reddy’s has also written a detailed letter to the Joint Drug Controller, citing several judicial proceedings in multiple high courts where no ban was imposed on Nimesulide. The company referred to a 2004 PIL in which DTAB had found Nimesulide safe, and provided additional studies and findings from independent bodies supporting the drug’s safety.
The company is trying to convince ICMR and experts that Nimesulide is non-fatal by referencing past DTAB evaluations that found the drug to be safe. Dr. Reddy’s has also provided data indicating safety in the human adult population, including safety data from India and international agencies, such as the WHO.
Overall, the debate around Nimesulide’s safety continues, with Dr. Reddy’s attempting to reassure the latest DTAB panel by referencing past evaluations that found the drug to be safe. However, the ICMR’s recommendation to ban formulations above 100 mg highlights the ongoing concerns around the drug’s safety profile. The final decision on the matter is pending approval from the Drug Controller General of India (DCGI).
Dr Reddy’s, a Hyderabad-based pharma company, set to launch Sanofi’s innovative medication in India, as reported by Telangana Today
Dr. Reddy’s Laboratories has expanded its partnership with Sanofi Healthcare to introduce a novel drug, Beyfortus, for the prevention of lower respiratory tract disease (LRTD) in newborns and infants. Beyfortus contains the monoclonal antibody nirsevimab and is administered via a prefilled injection. The medication is designed to prevent respiratory syncytial virus (RSV) LRTD in newborns and infants, as well as in children up to 24 months of age who are vulnerable to severe RSV disease.
RSV is a highly contagious virus that can lead to serious respiratory illness in infants. Under the partnership, Dr. Reddy’s will have exclusive rights to promote and distribute Beyfortus in India. The company plans to launch the drug in India in the second quarter of the current fiscal year. This announcement follows a successful partnership between Dr. Reddy’s and Sanofi for the distribution of vaccines in India last year.
The introduction of Beyfortus is a significant step in protecting children from immunization-preventable diseases like RSV. The drug has already been approved for use in several countries, including the European Union, the US, China, and Japan. In India, it received marketing authorization approval from the Central Drugs Standard Control Organisation (CDSCO) in June last year.
According to Dr. Reddy’s CEO, MV Ramana, Beyfortus provides healthcare professionals and parents with an improved option for preventing RSV. Nitya Padmanabhan, Head of Sanofi Vaccines (India), noted that bringing Beyfortus to India is a pivotal step in the company’s mission to protect every child from immunization-preventable diseases. The partnership between Dr. Reddy’s and Sanofi aims to increase access to this critical medication and improve the health outcomes of infants and young children in India.
Kyndryl partners with DRL to drive innovation.
Hyderabad-based pharmaceutical company, Dr. Reddy’s Laboratories Ltd, has partnered with US-based enterprise technology provider, Kyndryl, to transform its IT operations across all locations, including manufacturing plants, international sites, datacenters, cloud operations, and offices. As part of this partnership, Kyndryl will utilize its AI-powered digital business platform, Kyndryl Bridge, to automate the monitoring of Dr. Reddy’s hybrid computing landscape, and leverage actionable insights for failure prediction and prevention, auto remediation, self-healing, and self-help features.
The partnership aims to reduce manual interventions by about 60% through intelligent automation of operations, providing a single-pane analytics and IT dashboard that improves visibility into IT operations, including service performance, compliance posture, and risk controls. This will enable digital-led compliance and governance models, optimizing operational efficiency, enhancing regulatory compliance, agility, and end-user experience.
According to Lingraju Sawkar, President, Kyndryl India, the company’s advanced technology and expertise will support Dr. Reddy’s Laboratories’ digital transformation journey. The new operations model will achieve this by optimizing IT operations, reducing manual interventions, and providing real-time insights into IT performance, compliance, and risk controls.
The partnership is a significant step towards Dr. Reddy’s Laboratories’ digital transformation, and Kyndryl’s expertise in providing AI-powered open integration digital business platform, Kyndryl Bridge, will be instrumental in achieving this goal. With this partnership, Dr. Reddy’s Laboratories is poised to reap the benefits of a more efficient, agile, and digitally transformed IT environment, which will ultimately improve its competitiveness in the pharmaceutical industry.
Stock Market Updates for Dr. Reddy’s Laboratories
Recent Updates
Dr Reddy’s Laboratory Spun off into International business while its domestic operations merged with parent entity of holding company priced at Rs 5,000 crore to make an additional Rs 2,395 crore in tax.
Dr Reddy’s Laboratories Limited, a pharmaceutical company, has received a showcause notice from the Income Tax Department, demanding a massive amount of over Rs 2,395 crore. The notice is related to the merger of Dr Reddy’s Holdings Limited (DRHL) with the company in 2019. The tax department has proposed that the company had failed to declare income that had escaped taxation during the merger. The company has responded to the notice, stating that the merger was done in full compliance with legal requirements, including those under the Income Tax Act. Dr Reddy’s believes that no income has escaped taxation due to the merger and is reviewing the details to respond to the authorities.
The company has assured that it is taking the matter seriously and will handle it in accordance with legal procedures. Dr Reddy’s has also stated that its promoters are responsible for covering any liabilities arising from the merger and will protect and support the company and its officials in case any tax-related issues arise. The company will respond to the authorities with the necessary information and will take all necessary steps to resolve the matter. The exact reasons for the proposed demand of Rs 2,395.81 crore have not been disclosed.
The National Company Law Tribunal (NCLT) had approved the merger of DRHL with Dr Reddy’s Laboratories in 2022. However, the merger was effective from April 1, 2019, as per the approved scheme. Dr Reddy’s had demerged its domestic formulations business into DRHL in 2019. The company is currently reviewing the details of the notice and will take necessary steps to resolve the matter.
The former Dr. Reddy’s Laboratories in Shreveport is now up for grabs.
The former Dr. Reddy’s Laboratories pharmaceutical manufacturing site in Shreveport, Louisiana, is now up for sale. The 56-acre property, which was once home to 107 employees, was sold to Jaguar Labs Holdings, LLC, an affiliate of Ten Oaks Group. Realtor Chris Stokes, who has the exclusive listing on the property, says it’s an ideal location for a new pharmaceutical company or other businesses.
Stokes notes that the facility, which spans 308,000 square feet, has remained largely intact, with rows of equipment, warehouses filled with materials, and industrial pharmaceutical equipment still in place. The property is also equipped with 24-hour security and is climate-controlled, making it an attractive option for potential buyers.
The asking price for the facility is $18 million, which includes all the equipment and fixtures. However, Stokes notes that the price could drop if the buyer does not need all the items. Additionally, the facility’s 80-90 FDA licenses to manufacture different drugs can be purchased separately, making it an attractive option for pharmaceutical companies.
Stokes has reached out to several potential buyers, including pharmaceutical manufacturers and companies that make products with THC. He has also contacted Sen. Bill Cassidy, House Speaker Mike Johnson, and Louisiana economic development officials to spread the word about the facility.
The sale of the facility is seen as a opportunity to bring back a functioning pharmaceutical manufacturer to the area, which could benefit the local community, including LSU Medical Center. As Stokes notes, the facility is set up to meet the needs of the local scientific community, and a new pharmaceutical manufacturer could help create jobs and drive economic growth in the area.
Dr. Reddy’s Secures Exclusivity for Two Bio-Thera Biosimilars Across Asia Region
Dr. Reddy’s Laboratories, an Indian drugmaker, has secured regional rights to two biosimilars developed by Bio-Thera, a Chinese biotech company. The agreement grants Dr. Reddy’s the right to develop, manufacture, and market the biosimilars, which are replicas of Amgen’s blockbuster drugs, in Asia, excluding China.
The two biosimilars, CT-P6 ( biosimilar to Avastin/Lucentis) and CT-P7 (biosimilar to Herceptin), are being developed by Bio-Thera through its partnership with Amgen. The agreement is expected to benefit patients by making these high-cost medications more accessible and affordable in Asia.
Dr. Reddy’s, with its presence in over 25 countries, will leverage its extensive network, expertise, and manufacturing capabilities to commercialize the biosimilars in the region. Bio-Thera will focus on the Chinese market, where it has a strong presence.
The deal marks a significant milestone for Dr. Reddy’s, which has been expanding its presence in the Asian market. The company has already made significant inroads in the region, with a diverse portfolio of products and a strong distribution network.
The agreement with Bio-Thera is expected to further strengthen Dr. Reddy’s position in the Asian market, particularly in countries such as India, Indonesia, Malaysia, the Philippines, and Thailand, where there is a growing demand for high-quality, affordable healthcare solutions.
In addition to the Asia region, Dr. Reddy’s has also made strategic investments in the Latin American and Eastern European markets, demonstrating its commitment to expanding its global footprint.
The partnership with Bio-Thera is a testament to Dr. Reddy’s commitment to embracing innovative technologies and partnerships to drive growth. The deal is expected to create new opportunities for the company, improve patient access to high-quality medications, and contribute to Dr. Reddy’s growth in the Asian market.
Overall, the agreement between Dr. Reddy’s and Bio-Thera is a significant development in the biopharmaceutical industry, highlighting the growing trend of partnerships and collaborations to drive growth, improve patient access, and create new opportunities in the region.
Indian pharma major Dr. Reddy’s secures regional rights to two Biosimilars from Bio-Thera Pharmaceuticals, paving the way for further expansion of its biologics portfolio.
According to a recent article from Scrip, Dr. Reddy’s Laboratories has secured regional rights to a pair of biosimilars from Bio-Thera, a Chinese biotech company. The agreement grants Dr. Reddy’s the rights to commercialize Bio-Thera’s pegfedimondas ( pegfedlatin) and joblatu (adalimumab-rogen) biosimilars in various Asian markets, including India, China, and Southeast Asia.
Pegfedimondas, also known as FB-027, is a pegylated pegfilgrastim biosimilar, which is used to treat neutropenia, a condition characterized by low white blood cell count. Joblatu, or BT-081, is a biosimilar of Humira (adalimumab), a biologic medicine used to treat various autoimmune disorders.
The agreement marks a significant expansion for both Dr. Reddy’s and Bio-Thera, as they diversify their portfolios and reach new geographies. Dr. Reddy’s, an Indian pharma major, has been actively pursuing in-licensing agreements to strengthen its biosimilars pipeline, while Bio-Thera continues to grow its global presence through strategic partnerships.
This deal demonstrates the growing trend of partnerships between Indian and Chinese pharmaceutical companies, as they seek to leverage each other’s expertise, resources, and local knowledge to fuel growth. The agreement also underscores the increasing importance of biosimilars in Asia, where demand for affordable, high-quality biologics is growing rapidly.
The terms of the agreement have not been disclosed, but it is likely that Dr. Reddy’s will benefit from Bio-Thera’s expertise in developing and commercializing biosimilars, while Bio-Thera will gain access to Dr. Reddy’s established distribution network and local knowledge in the Asian market.
The agreement is also significant in the context of India’s growing biosimilars industry, with the country’s pharma sector poised to benefit from the increasing demand for affordable biologics. As Dr. Reddy’s looks to strengthen its biosimilars pipeline, this deal represents a key milestone in its efforts to become a major player in the global biosimilars market.
Overall, the agreement between Dr. Reddy’s and Bio-Thera highlights the growing trend of collaborations between Indian and Chinese pharma companies, as they seek to capitalize on each other’s strengths and expertise to fuel growth and tap into the rapidly expanding Asian biosimilars market.
Dr Reddy’s seals deal with China’s Bio-Thera, a strategic pact
Dr. Reddy’s Laboratories (DRL) has announced that its subsidiary, Dr. Reddy’s Laboratories SA, has entered into a commercialization and licensing agreement with Bio-Thera Solutions, a Chinese biopharmaceutical company, to develop and market biosimilars of two Janssen human monoclonal antibodies, Stelara (Ustekinumab) and Simponi (Golimumab), for the Southeast Asian market. The biosimilars, BAT2206 and BAT2506, are developed by Bio-Thera and will be manufactured and supplied by the company, while Dr. Reddy’s will be responsible for seeking regulatory approvals and commercializing them in licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, the Philippines, Thailand, and Vietnam.
As part of the agreement, Dr. Reddy’s will also have exclusive commercial rights to market BAT2206 in Colombia. The CEO of Dr. Reddy’s, MV Ramana, stated that the partnership will enable the company to expand its biosimilar offerings in emerging markets and provide access to affordable medicines for patients. The CEO of Bio-Thera, Dr. Shengfeng Li, noted that the partnership is the company’s first deal focused solely on Southeast Asia and that Dr. Reddy’s is the perfect partner to help bring their biosimilars to patients in the region. The agreement demonstrates Bio-Thera’s commitment to patients in Southeast Asia. The partnership is expected to benefit the patients in the region by providing access to affordable medicines.
Dr. Reddy’s divests 14 non-core assets to Senores Pharma, securing funding for its expansion into the US market.
Dr. Reddy’s, an Indian pharmaceutical company, has sold a portfolio of 14 Abbreviated New Drug Applications (ANDAs) to Ahmedabad-based Senores Pharmaceuticals. The acquired portfolio consists of 13 already approved ANDAs by the US Food and Drug Administration (FDA) and one pending approval. The market value of these ANDAs in the US is estimated to be between $421 million and $1.13 billion. Senores plans to fund the acquisition through proceeds from its upcoming initial public offering (IPO).
The acquired portfolio includes controlled substances and general category drugs that cater to demand across government, retail, and specialty clinics. Senores also sees strong growth potential in other regulated and semi-regulated markets worldwide. Dr. Reddy’s considers the products to be generic non-strategic assets.
The acquisition is a significant move for Senores, as it aims to expand its presence in the global generics market. The company plans to leverage the acquired portfolio to tap into new markets and further its growth trajectory.
It’s worth noting that Dr. Reddy’s has been streamlining its operations and focusing on its core products, which may have led to the divestment of this portfolio. The company has a history of acquiring and selling off non-core assets to focus on key areas of growth.
In related news, Dr. Reddy’s has been involved in several other transactions, including the settlement of a dispute with Impax over the generic version of Rytary. The company has also launched a generic version of Stromectol in partnership with Senores Pharmaceuticals. Overall, the sale of the ANDA portfolio is a significant move for Dr. Reddy’s, and it will be interesting to see how it impacts the company’s future growth and operations.