Dr. Reddy's Laboratories Limited, together with its subsidiaries, operates as an integrated pharmaceutical company North America, Europe, India, Russia, and internationally.
The company is committed to accelerating access to affordable and innovative medicines. The company's segments include Global Generics; Pharmaceutical Services and Active Ingredients ('PSAI'); and Others.
Global Generics
This segment consists of the company’s business of manufacturing and marketing prescription and over-t...
Dr. Reddy's Laboratories Limited, together with its subsidiaries, operates as an integrated pharmaceutical company North America, Europe, India, Russia, and internationally.
The company is committed to accelerating access to affordable and innovative medicines. The company's segments include Global Generics; Pharmaceutical Services and Active Ingredients ('PSAI'); and Others.
Global Generics
This segment consists of the company’s business of manufacturing and marketing prescription and over-the-counter finished pharmaceutical products ready for consumption by the patient, marketed under a brand name (branded formulations) or as generic finished dosages with therapeutic equivalence to branded formulations (generics). This segment includes the operations of the company’s biologics business, and the portfolio of consumer healthcare brands in the Nicotine Replacement Therapy category (the ‘NRT Business’) that it recently acquired is also included in this segment.
Pharmaceutical Services and Active Ingredients
This segment primarily consists of the company’s business of manufacturing and marketing active pharmaceutical ingredients and intermediates, also known as ‘API’, which are the principal ingredients for finished pharmaceutical products. Active pharmaceutical ingredients and intermediates become finished pharmaceutical products when the dosages are fixed in a form ready for human consumption such as a tablet, capsule or liquid using additional inactive ingredients. The company also serves its customers with incremental value-added products including semi-finished and finished formulations, which are included in this segment. This segment also includes the company’s pharmaceutical services business, which provides contract research services and manufactures and sells active pharmaceutical ingredients in accordance with the specific customer requirements.
Others
This segment consists of the company’s other business operations which includes its wholly owned subsidiaries, Aurigene Oncology Limited (‘AOL’) and its Proprietary Products business. AOL is a specialized biotechnology company engaged in discovery and early clinical development of novel, best-in-class therapies in the fields of oncology and inflammation. AOL works with established pharmaceutical and biotechnology companies through customized models of drug-discovery collaborations. The company’s Proprietary Products business is focused on the research, development and commercialization of differentiated formulations and it derives revenues from such assets through event specific milestones and subsequent royalties, if any.
The company’s key markets include the United States, India, Russia and other countries of the former Soviet Union, and Europe.
Strategy
The company's strategy is guided by its core purpose of accelerating access to affordable and innovative medicines, because 'Good Health Can't Wait'. As a global generic pharmaceutical company, the company's responsibility to patients worldwide is to offer affordable alternatives to expensive medicines and to help patients better manage their health.
Product and Service Offerings
Global Generics
The company has diversified into consumer health and innovative products with the aim to improve the standard of care available to patients.
Branded and Unbranded Generics: The company develops, manufactures, and markets a portfolio of high-quality generic drugs at an affordable price. The company seeks to have a portfolio of credible brands, focused on delivering first-to-market, differentiated products to doctors and patients in both branded and unbranded generics markets. The company’s vertical integration helps ensure that quality products are always available to patients. The company has also entered strategic partnerships with third parties to sell its products in markets.
Biosimilars: The company seeks to accelerate access to generic versions of biological products globally through its own fully integrated organization that spans development, manufacturing and marketing activities, in combination with strategic partnerships. Having launched multiple biosimilar products in India and other emerging markets, the company has also taken this business into highly regulated markets.
Consumer Healthcare: The company offers differentiated, science-backed and clinically proven consumer health products to holistically improve patients’ health outcomes and quality of life.
Innovation: The company seeks to cater to unserved, underserved or unarticulated patient needs by leveraging its endowments to bring innovation to the patient, including new chemical entities (‘NCEs’)/ new biological entities (‘NBEs’), cell and gene therapy (‘CGT’) and digital therapeutics.
Pharmaceutical Services and Active Ingredients (‘PSAI’): The company’s PSAI segment consists of its active pharmaceutical ingredients (‘API’) business and its pharmaceutical services business.
API: The company’s product offerings include complex, differentiated, high quality and affordable APIs, backed by strong chemistry and synthesis skills. This enables launches at competitive prices of the company’s own products as well as of its customers.
Pharmaceutical Services
Others: This segment consists of various other business operations including the company’s wholly owned subsidiaries, AOL and its Proprietary Products business. AOL is a specialized biotechnology company engaged in discovery and early clinical development of novel, best-in-class therapies to treat cancer and inflammatory diseases. The company’s Proprietary Products business focuses on commercialization of differentiated formulations through partnerships to maximize value.
The company continues to strengthen on its core generic businesses and build on the company’s future growth drivers to meaningfully improve the lives of patients by addressing unmet patient needs across the illness-to-wellness spectrum.
Principal Areas of Operations
Global Generics Segment
This segment includes North America (the United States and Canada), Europe, and 'Emerging Markets' (which is consisted of Russia, other countries of the former Soviet Union, Romania and certain other countries from the company's 'Rest of the World' markets, including Brazil, South Africa, China and Australia), as well as India.
The company is one of the leading generic pharmaceutical companies in the world. With the integration of all the markets where the company is selling generic pharmaceuticals into its Global Generics segment, the company’s front-end business strategies in various markets and its support services in India are increasingly being developed with a view to leverage the company’s global infrastructure.
India
During the year ended March 31, 2025, India accounted for 19% of the company’s total Global Generics segment sales. In India, the company’s key therapeutic categories include gastro-intestinal, cardiovascular and anti-diabetic, dermatology, oncology, respiratory, stomatology, urology, nephrology, Vaccines and pain management.
As of March 31, 2025, the company had a total of 443 branded products in India. The company’s top ten branded products together accounted for 23% of its revenues in India in the year ended March 31, 2025.
Sales, Marketing and Distribution Network
The company generates demand for its products through the company’s 9,000 sales representatives (which include representatives engaged by it on a contract basis through a service provider) and front-line managers, who frequently visit doctors to detail the company’s related product portfolio. They also visit various pharmacies to ensure that the company’s brands are adequately stocked.
The company sells its products primarily through clearing and forwarding agents to approximately 5,900 wholesalers who decide which brands to buy based on demand. The wholesalers pay for the company’s products within an agreed credit period and in turn sell these products to retailers. The company’s clearing and forwarding agents are responsible for transporting its products to the wholesalers. The company pays its clearing and forwarding agents on a commission basis. The company has insurance policies that cover its products during shipment and storage at clearing and forwarding locations.
Competition
The company’s competitors in the Indian market include Cipla Limited, GlaxoSmithKline Pharmaceuticals Limited, Zydus Lifesciences Limited, Sun Pharmaceutical Industries Limited, Alkem Limited, Abbott India Limited, Lupin Limited, Aristo Pharma Limited, Intas Pharmaceuticals Limited, Glenmark Pharmaceuticals Limited, Mankind Pharma Limited, Torrent Pharmaceuticals Limited, Macleods Pharma, and Emcure Pharmaceuticals Limited.
Government Regulations
As a company, the company continues to work with industry associations such as the Indian Pharmaceutical Alliance (‘IPA’) and the Federation of Indian Chambers of Commerce and Industry (‘FICCI’) on such matters of policy.
Before approving the company’s generic products, the Ministry of Health also requires that its procedures and operations conform to Current Good Manufacturing Practice (‘cGMP’) regulations, relating to good manufacturing practices as defined by various countries. The company must always follow the cGMP regulations during the manufacture of its products. The company continues to spend significant time, money and effort in the areas of production and quality testing to help ensure full compliance with cGMP regulations.
Russia and other Countries of the former Soviet Union and Romania
Russia
Russia accounted for 9% of the company’s Global Generics segment’s revenues in the year ended March 31, 2025.
The company’s top five brands, Nise, Omez, Femibion, Ibuclin and Nasivin accounted for 58.7% of its retail sales in Russia for the 12 months ended March 31, 2025, according to IQVIA data. Nise (pain management product, including systemic and topical form), Omez (an anti-ulcerant product), Femibion (vitamins for pregnant women), Ibuclin (for cold and flu) and Nasivin (for cold and flu) were the best-selling formulation brands, in the Russian market by IQVIA in its retail segment report for the moving twelve months ended March 31, 2025. (Nasivin and Femibion are distributed and promoted by it under a licensing agreement and the brand is owned by the licensor). The company’s strategy in Russia is to focus on the gastro-intestinal, pain management, cough and cold, allergy and oncology therapeutic areas. The company’s focus is on building leading brands in these therapeutic areas in prescription, over the counter and hospital sales.
The company operates in Russia through its subsidiary Dr. Reddy’s Laboratories LLC, Russia with an employee headcount of 911.
Since the beginning of the military conflict between Russia and Ukraine, the company is continuously monitoring emerging risks in the areas of safety of employees, supply chain disruption, repatriation of funds and information technology, including cyber security related risks.
The company operates in other countries of the former Soviet Union, including Ukraine, Kazakhstan, Belarus, Uzbekistan and Romania. For the year ended March 31, 2025, revenues from these countries accounted for 3% of the company’s total Global Generics segment’s revenues.
Sales, marketing and distribution network
The company’s marketing and promotion efforts in its Russia market is driven by a team of 565 medical representatives and 69 managers to detail the company’s products to doctors in 70 cities in Russia. The company’s commercial team consists of 16 key account managers and is focused on establishing a network of relationships with key pharmacy chains. The company’s Russia hospital division has 32 hospital specialists focused on expanding its presence in hospitals.
Competition
The company’s principal competitors in the Russian market include Berlin-Chemie/Menarini Pharma GmbH, KRKA Pharma Limited, Teva Pharmaceutical Industries Limited, Lek-Sandoz Pharmaceuticals (an affiliate of Novartis Pharma A.G.) and Zao Ranbaxy (an affiliate of Sun Pharmaceutical Industries Limited).
North America (the United States and Canada)
During the year ended March 31, 2025, North America (the United States and Canada) accounted for 50% of the company’s total Global Generics segment sales. In the United States, it sells generic drugs that are the chemical and therapeutic equivalents of reference branded drugs, typically sold under their generic chemical names at prices below those of their brand drug equivalents.
The company intends to continue building its presence in the region by leveraging the company’s product development capabilities and alliance management, manufacturing capacities inspected by various international regulatory agencies and access to its own APIs, which offer significant supply chain efficiencies.
Through coordinated efforts of the company’s teams in the United States and India, it constantly seeks to expand its pipeline of generic products. During the year ended March 31, 2025, the company filed 10 new Abbreviated New Drug Applications (‘ANDAs’) with the U.S. FDA. As of March 31, 2025, 76 generic filings were pending approval from the U.S. FDA. These consists of 73 ANDAs and 3 New Drug Applications (‘NDAs’) filed under Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act.
The company has two ongoing Investigational New Drugs (‘IND’) applications for its proposed biosimilars. For Rituximab, all clinical trials have been successfully completed, and the company’s Biologics License Application (‘BLA’) and New Drug Submission (‘NDS’) are under active review with the U.S. FDA and Health Canada, respectively. The company also received marketing authorizations for its Rituximab product in the European Union and the United Kingdom in 2024. For Abatacept, the company’s clinical studies are ongoing.
The company has also filed a BLA or Marketing Authorization Application (‘MAA’) for its proposed biosimilar Denosumab with the U.S. FDA and the European Medicines Agency (‘EMA’), and the company’s applications has been accepted for review. The company also has pre-INDs opened for two other early-stage molecules.
As of March 31, 2025, the company has filed a cumulative total of six NDSs, one Drug Identification Number (‘DIN-A’) Application, 80 Abbreviated New Drug Submissions (‘ANDS’) and one Class III Natural Health Product (NHP) in Canada, out of which 52 were approved, one tentatively approved (with Intellectual Property Hold status), 14 were withdrawn or cancelled and 20 are pending approval.
Sales, Marketing and Distribution Network
Dr. Reddy’s Laboratories, Inc., the company’s wholly owned subsidiary headquartered in Princeton, New Jersey, United States, is primarily engaged in the marketing of its generic products in the United States. In early 2003, the company commenced sales of generic products under its its label. The company has own sales and marketing team to market these generic products. The company’s key account representatives for generic products call on procurement buyers for chain drug stores, drug wholesalers and distributors, mass merchandisers, GPOs for hospitals, specialty distributors and pharmacy buying groups.
The majority of revenue from the company’s North America Generics business is derived from sales of various products (both oral solids and OTC products) to retail chains, wholesalers and private labels, as well as sales of oral solids to other categories of customers. This portion of the business represents nearly three quarters of this segment’s gross revenues for this region. The product portfolio includes a wide range of therapeutic areas.
The company’s over the counter (‘OTC’) division primarily markets and distributes store brand OTC products, but expanded into the branded OTC segment in May 2016, developing a new channel for its growth. This division has successfully launched over 25 products. OTC products include store brand generic equivalents of products that approved to be sold Over the counter in the U.S. market. The company’s OTC division services a broad range of customers, including drug retailers, mass merchandisers, food chains, drug wholesalers, distributors, GPOs, and more recently, e-commerce or online retailers as well. Over last few years, the company has substantially expanded its portfolio offering. The company launched four new products in the market during the year ended March 31, 2025, which included OTC Esomeprazole Tabs, OTC Omeprazole and Sodium Bicarbonate Powder for Oral Suspension, OTC Acetaminophen and Ibuprofen Tabs and OTC Esomeprazole Mini Capsules.
During the year ended March 31, 2025, the company continued to build out its presence in the Self-care and Wellness space by focusing on building out the company’s consumer health brands as part of its innovation initiatives. This included ramping the company’s e-commerce only brand HealthCareAisle, which included growing its share on base products and launching of multiple new products on the Amazon marketplace. The company also started renovating its existing brands of Doan’s and Habitrol and the company also completed the integration of the MenoLabs business, which it acquired from Amyris in its Chapter 11 bankruptcy sales process back in Dec 2023. MenoLabs is a leading women’s health and dietary supplement branded portfolio which includes multiple branded products designed to provide health support and address symptoms of perimenopause and menopause.
A portion of the company’s revenues are derived from the sale of injectable products in the therapeutic areas of oncology and critical care. The company has also expanded its presence from drug wholesalers to specialty distributors, integrated distribution networks, clinics, and hospitals to market these products. The company also supplies products for private label customers for injectable prescription products.
Competition
The company’s major competitors in the United States include Teva, Viatris Inc., Sandoz (a division of Novartis Pharma A.G.), Endo International plc (including its subsidiaries Endo Pharmaceuticals Inc. and Par Pharmaceutical Inc.), Sun Pharmaceuticals Limited, Lupin Limited, Aurobindo Pharma Limited, Fresenius Kabi, Sagent Pharmaceuticals, Amneal Pharmaceuticals, Inc., Zydus Pharmaceuticals (USA) Inc., and Hikma Pharmaceuticals plc.
In the store brand market, the company competes directly with companies, such as Perrigo, Apotex, Aurobindo, Sun Pharma and Granules that sell store brand OTC products. In the branded market, the company competes directly with companies, such as Bayer and GSK, which sell branded OTC products.
Government Regulations
The company’s facilities and products are routinely inspected by the U.S. Food and Drug Administration (U.S. FDA) to ensure compliance with current Good Manufacturing Practices (‘cGMP’).
The company also introduced the Generic Drug User Fee Act (‘GDUFA’) and Biosimilar User Fee Act (‘BsUFA’), enabling the U.S. FDA to collect user fees to support the review of generic and biosimilar applications.
The company also issued final guidance in August 2023 on acceptable intake limits for nitrosamine impurities and draft guidance in February 2024 on reporting manufacturing disruptions under section 506C of the FD&C Act.
The company is also subject to Section 6002 of the Patient Protection and Affordable Care Act, commonly known as the Physician Payment Sunshine Act, which regulates disclosure of payments to certain healthcare professionals and providers.
In Canada, the company is required to file product dossiers with the Health Canada for permission to market a generic pharmaceutical product. As of March 31, 2025, the company has filed a cumulative total of six New Drug Submission (‘NDS’), one Drug Identification Number (‘DIN-A’) Application, 80 Abbreviated New Drug Submissions (‘ANDS’) and one Class III Natural Health Product (NHP) in Canada, out of which 52 were approved, 1 tentatively approved (IP Hold), 14 were withdrawn or cancelled and 20 are pending approval.
Europe
The company’s principal markets in Europe are Germany, France, Italy, Spain, and United Kingdom as well as the global portfolio outside of the United States of consumer brands in the Nicotine Replacement Therapy category which it acquired from Haleon UK Enterprises Limited (the ‘Acquired NRT Business’). In addition, through distribution partners the company accesses its portfolio of hospital customers. These markets include Austria, Albania Belgium, Czech Republic, Denmark, Finland, Ireland, Kosovo, Netherlands, Poland, Portugal, Slovakia, Norway, and Sweden.
Sales, Marketing and Distribution Network
Germany
In Germany, the company sells a broad range of generic pharmaceutical products under the ‘betapharm’ brand.
Germany – acquisition of medical Cannabis Business Nimbus Health
The acquisition of Nimbus Health GmbH (‘Nimbus Health’) in February 2022 marked the company’s entry into the medical cannabis sector. Founded in 2018, Nimbus Health is one of Germany’s pioneer companies for medical cannabis. The acquisition allows it to build on Nimbus Health’s strengths and introduce medical cannabis-based medicines as a promising treatment option for patients. The acquired company operates under the brand Nimbus Health and is the company’s wholly owned subsidiary.
Switzerland - acquisition of Haleon’s Global Portfolio of Consumer Health Brands
During the year ended March 31, 2025, the company completed the acquisition of Haleon UK Enterprises Limited’s global portfolio of consumer healthcare brands, outside of the United States, in the Nicotine Replacement Therapy category.
United Kingdom and other Countries within Europe
The company markets its pharmaceutical products in the United Kingdom through the company’s U.K. subsidiary, Dr. Reddy’s Laboratories (U.K.) Limited, which was formed in 2003. The company sells more than 65 products in the United Kingdom, covering both International Nonproprietary Name generics, branded generics, biosimilars and over-the-counter medicines. The company’s portfolio is sold via wholesale, retail and hospital channels, OTC products are available in mass channels and via e-commerce channels. While the retail business covers a broad range of therapeutic areas, the hospital business focuses on key areas such as oncology, anti-invective and HIV. In this fiscal year, the company launched its first private label product to leading pharmacy chain continuing the company’s efforts in OTC segment. The company has successfully started distribution of the biosimilars in UK, launching bevacizumab with brand name Versavo.
Through the company’s subsidiaries in France, Italy and Spain it has established itself as a trusted partner for the countries hospitals segment.
The company’s product mix in these markets focuses on a limited number of key therapy areas, such as pulmonary hypertension, oncology, anti-infective and HIV, leveraging its portfolio.
The company works with partners who make its products available in Austria, Albania Belgium, Czech Republic, Denmark, Finland, Ireland, Kosovo, Netherlands, Poland, Portugal, Slovakia, Norway, and Sweden. This strategy allows the company to scale its operations across Europe.
Competition
The company’s key competitors within the German generics market include Sandoz International GmbH, Teva Pharmaceutical Industries Limited (‘Teva’), Zentiva Pharma GmbH and Stada Arzneimittel AG.
In Italy, Spain and France, the company competes with companies, such as, Zentiva, Ever Pharma, Medac, Teva and Accord Healthcare Limited (an affiliate of Intas Pharmaceuticals Ltd.), each of which has a well-established presence in the hospital segment of these countries.
Government Regulations
The company’s U.K. facilities are licensed and periodically inspected by the U.K. Medicines and Healthcare Products Regulatory Agencies (‘MHRA’) good manufacturing practice Inspectorate, which has extensive enforcement powers over the activities of pharmaceutical manufacturers.
‘Rest of the World’ markets of the company’s Global Generics segment.
The company refers to all markets of its Global Generics segment other than North America, Europe, Russia and other countries of the former Soviet Union and Romania and India as the company’s ‘Rest of the World’ markets. The company’s significant Rest of the World markets include Brazil, South Africa, China, Vietnam, Colombia, Australia and Myanmar.
The company started its operations in China in the year 2000, by setting up a joint venture in the city of Kunshan, Jiangsu Province. Over the past several years, the company’s joint venture called Kunshan Rotam Reddy Pharmaceuticals Company Limited (‘KRRP’) has commercialized several products. Some of these products are manufactured by KRRP at its manufacturing plant in Kunshan while some others are imported in bulk packs, repackaged and sold in China.
Over the last few years, the company has also increased its operations with respect to the filing of dossiers and obtaining new product registrations in China. Upon successful registration and approval by the China regulatory authorities, the company intend to launch these products in the coming years.
The company’s product Olanzapine, which it had commercialized in China through a distribution and supply agreement with a Chinese company, was successfully listed in volume based procurement program, which is a tender-style bidding system for centralized procurement of medicines in China.
The company’s facilities and products are periodically inspected by various regulatory authorities, such as the U.S. Food and Drug Administration (the U.S. FDA), the U.K. Medicines and Healthcare Products Regulatory Agencies (MHRA), the German BfARM, the South African Medicines Control Council, the Brazilian ANVISA, the Romanian National Medicines Agency, Ukrainian State Pharmacological Center, the local World Health Organization and Drug Control Authority of India, all of which has extensive enforcement powers over the activities of pharmaceutical manufacturers operating within their jurisdiction.
Pharmaceutical Services and Active Ingredients (‘PSAI’) segment
The company’s PSAI segment primarily includes its business of manufacturing and marketing active pharmaceutical ingredients (‘APIs’) including intermediates, as well as its pharmaceutical services business.
Active Pharmaceutical Ingredients
The company’s more than 150 different APIs have regulatory approvals filed in numerous markets and enable its generic manufacturing partners to bring formulated products in forms such as tablets, capsules, or injectable to patients worldwide. The company can also provide customers with intermediates, which are the pre-stage of a final API. In addition to the company’s external partners, its API business also supplies the company’s own generic business.
During, the year ended March 31, 2025, the company filed 111 Drug Master Files (‘DMFs’) worldwide, of which 14 were filed in the United States, 8 were filed in Canada, 8 were filed in Europe and 81 were filed in other countries. Cumulatively, the company’s total active DMFs filed worldwide as of March 31, 2025, were 1,629, including 264 active DMFs filed in the United States.
The company exports APIs to more than 70 countries, and its main markets include North America (the United States and Canada), Europe and Southeast Asia, Middle East and Africa. The research and development group within the company’s API business contributes to its business by creating intellectual properties, principally by developing novel and non-infringing manufacturing processes and polymorphs.
Pharmaceutical Services business – Aurigene Pharmaceutical Services Limited
The company’s PSAI segment also includes its Pharmaceutical Services business, which provides contract discovery (research), development, and manufacturing to global pharmaceutical companies. As a contract development and manufacturing organization (‘CDMO’), the business is operated independently under its own entity Aurigene Pharmaceutical Services Limited and works on new chemical entities (‘NCEs’) and new biological entities (‘NBEs’) for global pharmaceutical companies and biotechnology companies. The pharmaceutical services (contract research, development and manufacturing) arm of the company’s PSAI segment was established in 2001 to leverage its strength in research and development to serve the niche segment of the innovator pharmaceutical and biotechnology companies.
The focus is to leverage the company’s skills in discovery, CDMO (process and analytical development for drug substance and formulation), and large-scale commercial manufacturing to serve outsourcing needs of global pharmaceutical and biotechnology companies. The company has positioned its PSAI segment’s Pharmaceutical Services business to be the partner of choice for large, medium and emerging innovator companies across the globe, with service offerings spanning the entire value chain of pharmaceutical services.
Effective June 1, 2020, the company carved out its discovery service business from Aurigene Oncology Limited (‘AOL’) and the company’s contract development and manufacturing services business from Dr. Reddy’s Limited and the integrated business model was commenced under Aurigene Pharmaceutical Services Limited (‘APSL’). APSL is a subsidiary of AOL within the company’s group. APSL was formed to service the needs of innovator customers in the areas of discovery, development and manufacturing services for clinical and commercial needs. The company’s aspiration is to make APSL a global leader in offering end-to-end integrated solutions across discovery, development and manufacturing.
Sales, Marketing and Distribution
The company supports its local customers through the company’s commercial offices in various markets, including Brazil, China, Europe, India, Japan, Mexico, the United States, United Arab Emirates and Russia with colleagues from regulatory affairs and commercial.
Developed Markets: The company’s PSAI segment’s principal overseas markets are the United States and Europe, which contributed for 48% of its PSAI segment’s revenue for the year ended March 31, 2025.
In the United States and Europe, in recent years expirations of the patent protection for high value branded pharmaceutical products were much less frequent, which resulted in a decrease in new opportunities in these markets for the customers of the company’s PSAI segment. The company markets its products through the company’s subsidiaries in the United States and Europe. These subsidiaries are engaged in all aspects of marketing activity and support the company’s customers’ pursuit of regulatory approval for their products, focusing on building long-term partnerships through customer service excellence.
India: India is an important market for the company’s PSAI segment that accounted for 7% of the PSAI segment’s revenues in the year ended March 31, 2025. The market in India is highly competitive, with severe pricing pressure and competition from lower cost imports.
Other Key Markets: The company’s PSAI segment’s sales to all of the other markets (excluding the United States, Europe and India) for the year ended March 31, 2025, and accounted for 46% of its PSAI segment’s revenues for the year.
The company’s commitment to the Chinese market shows through a strong pipeline of products for the Chinese market and its local presence of business development and regulatory affairs experts. Further key markets include Brazil, Mexico Korea and Japan. While the company works through its agents in some of these markets the company’s local marketing and regulatory affairs associates are an important interface to understand and serve customers in those regions.
For the company’s contract development and manufacturing services line of business, it has focused business development teams dedicated to the company’s key geographies of North America (the United States and Canada), the European Union and Asia Pacific. These teams target large, medium and emerging innovator companies to build long-term business relationships focused on catering to their outsourcing needs from discovery to commercialization.
Going forward, the company expect its PSAI segment to show growth on account of its investments in technologies and platforms such as peptides. The company is also pursuing a partnership model to enable its customers to reach more markets faster and efficiently by leveraging the company’s cost leadership and presence across the globe. The company’s PSAI Segment has been investing in digital solutions to revitalize its engagement and transparency with the company’s customers. The company laid an important foundation with these initiatives, which it continues to build on.
The company is committed to enhancing the accessibility and affordability of medicines for vulnerable populations, promoting greater equity in healthcare.
PSAI Manufacturing
The infrastructure for the company’s PSAI segment consists of eight U.S. FDA-inspected plants (six in India, including one in a Special Economic Zone, one in Mexico, and one in Mirfield, United Kingdom) and two technology development centers (one in Hyderabad, India and one in Cambridge, United Kingdom).
India: All the company’s facilities in India are in the states of Andhra Pradesh and Telangana. The company has the flexibility to produce quantities that range from a few kilograms to several metric tons. The manufacturing process consumes a wide variety of raw materials that the company obtains from various sources that comply with the requirements of regulatory authorities in the markets to which it supplies its products. The company procures raw materials based on its requirement planning cycles. The company utilizes a broad base of suppliers to minimize risk arising from dependence on a single supplier.
Mexico: The company’s manufacturing plant in Cuernavaca, Mexico (the ‘Mexico facility’) was acquired from Roche during the year ended March 31, 2006. In addition to active pharmaceutical ingredients, naproxen and naproxen sodium and a range of intermediates, the Mexico facility manufactures steroids as active ingredients for use in human and veterinary pharmaceutical products.
United Kingdom: The small molecules business continues to supply complex APIs to customers at a range of scales. This business is also able to provide cost effective contract development and manufacturing organization solutions to innovators developing new pharmaceutical products, tapping into the expertise of the company’s parent company as required.
The company has invested in this business to update equipment and implement modern data acquisition systems to meet today’s stringent regulatory requirements.
For the company’s contract development and manufacturing services, it has well-resourced synthetic organic chemistry laboratories, medicinal chemistry analytical laboratories and kilo laboratories at the company’s research and development centers at Hyderabad and Bengaluru in India. The company’s chemists and process engineers are experts in discovery, development and manufacturing services, from the pre-clinical stage to commercialization. To complete the full value chain in development services, the company also provides formulation development services. The company has facilities for pre-formulation and formulation development, analytical development, clinical trial supplies, pilot scale and product regulatory support. This facility also follows rigorous Safety and Information Security practices and is certified against ISO 27001:2013 standards for information security. Larger quantities of APIs can be manufactured from the company’s API plants in India, the United Kingdom and Mexico. The company also offers end to end project management support for effective deliveries.
The company’s contract development and manufacturing services are uniquely positioned in the market where it utilizes assets (both in terms of physical assets and technical know-how) of a vertically integrated pharmaceutical company and combines this with the service model which it has built over the years.
Competition
The company’s main competitors in this segment are Divis Laboratories Limited, Aurobindo Pharma Limited, Cipla Limited, Mylan Laboratories Limited, Sun Pharmaceutical Industries Limited and MSN Laboratories Limited, all based or operating in India. In addition, the company experiences competition from European and Chinese manufacturers such as Zhejiang Huahai, Tianyu, as well as from Teva Pharmaceuticals Industries Limited, based in Israel.
Government Regulations
The company submits a DMF for active pharmaceutical ingredients to be commercialized in the United States. For European markets, the company submits a European DMF and, wherever applicable, obtain a certificate of suitability from European Directorate for the Quality of Medicines.
Others Segment
AOL: AOL is a clinical stage biotech company committed to developing innovative and effective cancer therapeutics. AOL has successfully discovered 21 novel chemical entities for clinical development. Some of these molecules were developed in collaboration with global pharmaceutical and biotechnology companies while others were developed independently. The company has out-licensed several first-in-class and best-in-class assets to pharmaceutical and biotechnology companies for global clinical development, while undertaking clinical proof of concept studies for a few programs on its own. Over the years, AOL has developed multiple discovery platforms, including kinase inhibitors, targeted protein degraders, antibody engineering and cell and gene therapy, resulting in a pipeline of first-in-class and best-in-class assets.
Proprietary Products: The company’s Proprietary Products business, over the years, focused on the development of differentiated pharmaceutical products across multiple therapeutic areas including dermatology and central nervous system. Initially the commercialization of these products was carried out through launching in the U.S. market and subsequently through product divestiture and out-licensing to various partners in the United States and Europe. The products licensed out included not only the approved and marketed products but also the ones in the development stages. The company derives revenues from these products through event specific milestones and royalties.
Agreement with Nestlé India Limited (‘Nestlé India’)
In April 2024, the company entered into a definitive agreement with Nestlé India Limited (‘Nestlé India’), for manufacturing, developing, promoting, marketing, selling, distributing, and commercializing nutraceutical products and supplements in India.
Agreement with Alvotech hf. (‘Alvotech’)
In May 2024, the company entered into a license and supply agreement with Alvotech for the commercialization of 'AVT03, Alvotech’s biosimilar candidate to Prolia and Xgeva (denosumab). This product is intended for the treatment of various diseases, including osteoporosis in postmenopausal women, and for the prevention of skeletal-related events in adults with advanced malignancies. This collaboration combines the company’s global commercial presence with Alvotech’s proven capabilities in developing biosimilars for worldwide markets.
In March 2025, the U.S. FDA accepted a Biologic License Application submission for AVT03, which marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.
Distribution Agreement with Novartis Pharma LLC (‘Novartis Pharma’)
In May 2024, the company entered into a distribution agreement with Novartis Pharma LLC (‘Novartis Pharma’) to sell and distribute the anti-diabetes products Galvus and Galvus Met, which are leading brands among Dipeptidyl Peptidase-4 (DPP4) molecules. This partnership brings the company synergies in its cardio and diabetes portfolio in the Russia territory.
Acquisition of business from Haleon UK Enterprises Limited (‘Haleon’)
In June 2024, the company entered into a definitive agreement with Haleon UK Enterprises Limited (‘Haleon’) to acquire Haleon’s global portfolio outside of the United States of consumer healthcare brands in the Nicotine Replacement Therapy category (the ‘NRT Business’).
Agreement with Shanghai Henlius Biotech, Inc. (‘Henlius’)
In February 2025, the company entered into a licensing agreement with Shanghai Henlius Biotech, Inc. (''Henlius'') to commercialize both the subcutaneous and intravenous formulations of the biosimilar product, ‘daratumumab biosimilar HLX15' in the United States and Europe. This product is intended for the treatment of multiple myeloma. This collaboration combines the company’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide.
Research and Development
The company's research and development expenses were Rs.27,380 million for the year ended March 31, 2025.
History
Dr. Reddy's Laboratories Limited was founded in 1984. The company was incorporated in India under the Companies Act, 1956, by its promoter and the company's former Chairman, the late Dr. K. Anji Reddy, in 1984.
