Top 17 Leading Generic Drugs Companies Worldwide

Generic drugs first appeared in 1984, when the Hatch-Waxman Act encouraged the manufacture of generic drugs and developed system regulation. In contrast to branded products, generic drugs have the same API pharmacokinetic and pharmacodynamic properties. It is also bioequivalent to currently available branded drugs but differs in fillers, preservatives, form, packaging, and flavor.

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• Hisun Pharmaceutical is a comprehensive pharmaceutical enterprise that specializes in the research, development, production, and sales of innovative drugs, biological drugs, and generic drugs.
• The cost-effectiveness of these drugs and the growing adoption of pure generic drugs in developing countries primarily drive the segment’s growth.
• In many emerging markets, our products are available under a brand name, such as Omez (Omeprazole), Nise (Nimesulide),Ketorol (Ketorolac Thromethamine), Stamlo (Amlodipine Besylate), Razo (Rabeprazole), among many others.
• They specialize in pharmaceutical trading, contract development and manufacturing, and pharmacovigilance.
• In South East Asia, Thailand has implemented the ‘National List of Essential Medicines’, which prioritises generics in government procurement and healthcare delivery, ensuring that the public healthcare system provides cost-effective treatment options.

In 2020, Mylan merged with Upjohn to form Viatris Inc., marking the end of its independent existence. Aspen Pharmacare Holdings Ltd (Aspen) is a prominent supplier of specialty and generic pharmaceuticals for the treatment of various acute and chronic ailments. Aspen Pharmacare has a robust quality management system and adheres to strict regulatory compliance standards and is approved by multiple regulatory agencies on a global level. Aspen’s generic drugs provide a cost-effective option for patients, thereby enhancing accessibility to its products for a broader population, particularly in emerging markets. The company operates across various regions, including Sub-Saharan Africa, South East Asia, Latin America, Eastern Europe, Western Europe, and the Commonwealth of Independent States. Lupin Limited is an Indian pharmaceutical firm, that has firmly established a prominent presence in the global generic drug market.

Expanding Access to Medicines: The Role of Generics in Emerging Markets

In Europe, Freseniusswiftly introduced Sugammadex, a neuromuscular block reversal agent, to themarket upon patent expiry. The administration said claims suggesting the generic drug is less effective are based on personal experiences. The ongoing study centers on assessing the availability, affordability, and acceptability of essential medicines under the PMBJP initiative. Learn more about the BMI products and services that empower you to make critical business decisions with confidence.

Access to Medicine Foundation

One of the sub-industries within pharmaceuticals is the generic drugs sector, which focuses on producing affordable versions of brand-name drugs. The top 10 generic drugscompanies in the world represent the pinnacle of innovation, efficiency, andcommitment to providing high-quality and affordable medications to millions ofpatients worldwide. These companies have demonstrated exceptional growth, strategicforesight, and operational excellence, enabling them to navigate complexregulatory environments and fierce competition within the pharmaceuticalindustry. Amneal Pharmaceuticals is a pharmaceutical company that specializes in the development and production of essential medicines. They have a broad portfolio of approximately 270 generic and specialty pharmaceuticals, and they are committed to improving the lives of patients and care for the communities they serve.

Top 17 Leading Generic Drugs Companies Worldwide

Healthcare costs are growing significantly, making it difficult for people to afford quality healthcare. Due to this, the demand for affordable healthcare is growing in the Latin American region, driving the generic drugs market in Latin America as these drugs are an effective alternative to branded drugs. In addition, the growing chronic disease patient population in the Latin American region and the increasing number of generic drug manufacturing activities further fuel the growth of the generic drugs market in Latin America. On the other hand, the branded generic drugs market had decent occupancy in the global market in 2023 and is predicted to showcase a CAGR of 8.8% during the forecast period. The growing demand for quality drugs with a trusted brand name is majorly boosting segmental growth.

• Their commitment to producing affordable medicines without compromising quality has reshaped the global pharmaceutical landscape.
• The Emerging Markets sector includes the Company’s ARV franchise as well as activities in countries with developing markets and emerging economies, including Asia, the Middle East, South, and Central America, Africa, and Eastern Europe.
• The generic drugs industry has a profound influence on various sectors, including healthcare, insurance, and consumer spending.
• Specializing in prescription medicines, vaccines, and consumer healthcare products, GSK offers a diverse portfolio spanning respiratory, HIV, oncology, and vaccines.
• Viatris seeks to provide improved access to inexpensive, high-quality medications for patients worldwide, regardless of region or circumstance, by combining the assets of these two businesses.

Victoza & Saxenda Revenue, USDmn (FY2015-FY2024e)

The Indian pharmaceutical industry is a global leader, with the domestic market poised to reach US$ 65 billion by 2024 and an expected surge to US$ 130 billion by 2030. Currently ranked 3rd globally in pharmaceutical production by volume and 14th by value, India commands a 20% share in global generic medicine supply and dominates vaccine manufacturing with a 60% market share. The generics industry is positioned to enhance access to essential health products in low- and middle-income countries.

MARKET RESTRAINTS

Auro Peptides, a subsidiary of Aurobindo Pharma Limited,concentrates on the development of peptide-based generic APIs, with aparticular focus on the oncology and diabetology segments. Teva Argentina is a leading pharmaceutical laboratory that develops and produces high-quality medications to improve the lives of patients and their communities. Committed to health, Teva is a global leader in generic and specialty medicines across various therapeutic areas. Sandoz is a pharmaceutical company that focuses on prescription and over-the-counter medicines. Normon is a pharmaceutical company that has been manufacturing high-quality prescription and non-prescription drugs for 80 years.

The Importance of Generics in Emerging Markets

Sun Pharmaceutical Industries Limited is a Mumbai-based Indian multinational pharmaceutical firm that develops and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States. Psychiatry, anti-infectives, neurology, cardiology, orthopedics, diabetology, gastroenterology, ophthalmology, nephrology, urology, dermatology, gynecology, respiratory, oncology, dental, and nutrition are among the therapeutic categories covered by the goods. Its API products include Acamprosate Calcium, Alendronate Sodium, Amifostine trihydrate, Budesonide, and Carvedilol. Viatris has over 1,400 approved compounds across a broad spectrum of therapeutic areas, including globally renowned iconic and key brands, generics, complex generics, and biosimilars. Viatris manufactures oral solid dosages, injectable, complicated dosage forms, and APIs at roughly 50 manufacturing sites across the world. Viatris is based in Pittsburgh, Pennsylvania, with global offices in Shanghai, China, and Hyderabad, India.

Generic Drugs Market

In2023, Teva obtained tentative approvals for generic counterparts of variousproducts including Tofacitinib Tablets, Fidaxomicin Tablets, EncorafenibCapsules, among others, while ensuring no duplication of applications. Discover the Top 17 Healthcare Diagnostics Companies revolutionizing healthcare with innovative diagnostic solutions. The concept of digital health is having a big impact on healthcare, especially when it comes to improving … InFebruary 2023, a wholly owned subsidiary of Sun Pharma secured final approvalfrom the US Food and Drug Administration (FDA) for its Abbreviated New DrugApplication (ANDA) concerning generic lenalidomide Capsules in multiplestrengths. Similarly, in May 2022, the company received final FDAapproval for its ANDA for generic Mesalamine Extended Release Capsules, 500 mg,based on Pentasa® Extended-Release Capsules, 500mg as the reference product. To enhance oversight of bulk-buy medications, the administration said it is committed to conducting regular and random checks on drugmakers that win bids and will promptly address any issues.

Top 27 Manufacturers of Quality Road Bikes

• These are companies producing drugs that have exactly the same active ingredients as brand-name drugs, but are accessible at a fraction of the cost.
• By producing bioequivalentversions of brand-name medications, generic drug companies dramatically reducecosts while maintaining the same therapeutic efficacy.
• Inthe European market, Aurobindo Pharma Limited maintains a robust presenceacross 10 countries, boasting fully operational pharmacies, hospitalfacilities, and a comprehensive infrastructure for tender sales.
• The export of generic medicines enables countries to share their pharmaceutical resources and expertise with others.
• Generic drugs first appeared in 1984, when the Hatch-Waxman Act encouraged the manufacture of generic drugs and developed system regulation.
• India excels in generic medicine production, commanding 20% of global supply and leading vaccine manufacturing.
• In 2023, notable additions included the anticoagulant apixaban, thediabetes medication sitagliptin, and the analgesic tapentadol.
• These drugs undergo stringent testing to ensure they are bioequivalent to their branded counterparts, offering the same safety and efficacy.

The company’s overarching objective is to assume a prominent globalposition in generics, pioneering medicines, and biopharmaceuticals, therebyenhancing patient well-being. Sun Pharma is a global pharmaceutical company committed to conducting business with the highest standards of professional integrity and ethical behavior. They offer a wide range of pharmaceutical products and aim to improve the health and well-being of people around the world.

Companies are engaging in adaptive R&D, tailoring products to the needs of people in LMICs

With the prevalence of T2D increasing globally, the demand for effective and affordable treatments is expected to rise, creating a sizeable market for generics. When it comes to expanding access to medicine, the power of the generics industry is often underestimated. It’s more than the transactional relationship of selling drugs at volume and competing on price.

Top 16 Affordable Generic Medications Companies

Metformin, metoprolol, amphetamine salt combo, acyclovir, bupropion HCL tablet, cholestyramine, ibuprofen tablet, letrozole, and verapamil are some examples of generic drugs. The Sandoz Division of the corporation is a global leader in generic pharmaceuticals and biosimilars, pioneering unique techniques to help people access high-quality medications all around the world. Sandoz is the only generics firm in the top three in all major regions of the world, reaching over 500 million people annually and helping healthcare systems save money around the world. They have over 1,000 molecules covering a wide range of therapeutic areas and are a renowned pioneer in antimicrobials with over 150 product and technology combinations. Avet Pharmaceuticals Inc. is a pharmaceutical company that specializes in the production and distribution of various medications, including tablets, capsules, and injectables.

Par Pharmaceutical is a pharmaceutical company dedicated to helping people by providing quality medicines. They specialize in modified-release oral solid dosage forms and alternative drug delivery platforms such as nasal sprays and patches. In low and middle-income countries (LMICs), generics make up 70-80% of the private sector market share. However, while Europe and the United States have seen a significant increase in generic medicine usage, there has been little change in Asia and the Middle East/South Asia region. In Europe, generic medicine volume rose from 42% in 2005 to 49.0% in 2009, and in the US, around 80% of prescriptions in retail pharmacies were for generics.

Industry

Encouragingly, the report found strong examples of how companies are engaging in adaptive R&D to tailoring products to the needs of people in LMICs, with nine adaptive R&D projects identified among the companies in scope. These include products specifically adapted for children; products adapted so that they do not require refrigeration; and formulations that simplify dosing regimens. BCC Research provides objective, unbiased measurement and assessment of market opportunities with detailed market research reports. Our experienced industry analysts assess growth opportunities, market sizing, technologies, applications, supply chains and companies with the singular goal of helping you make informed business decisions, free of noise and hype. Beyond his professional achievements, Anil is deeply passionate about the intersection of technology and healthcare. He is committed to staying at the forefront of industry innovations, ensuring that his work consistently exceeds client expectations.

Aurobindo Pharma Limited

However, challenges such as patent litigations and strict regulations continue to shape the industry. Teva Pharmaceutical Industries Ltd. is a global leader in the generic drug market, with a history dating back to 1901. Specializing in affordable alternatives to brand-name medications, Teva offers a diverse portfolio covering various therapeutic areas.

Viatris is a global pharmaceutical company offering a wide range of therapeutic products and services. They focus on providing branded and generic medications, active pharmaceutical ingredients (APIs), and over-the-counter products. With a commitment to sustainability and corporate responsibility, Viatris aims to improve global healthcare and enhance patient outcomes. Lupin is a global pharmaceutical company that specializes in the development, manufacture, and sale of a wide range of generic and specialty drugs. With a focus on key therapeutic areas like cardiovascular and respiratory health, Lupin offers innovative and cost-effective solutions to patients and healthcare providers worldwide.

Companies are engaging in adaptive R&D, tailoring products to the needs of people in LMICs

They started with the production of solid dosage forms and later expanded to other types of dosages. Their goal is to provide reliable and affordable pharmaceutical facilities to all types of customers. This is the first research report from the Generic & Biosimilar Medicines Programme, with analysis carried out using the Analytical Framework published in February 2023.

Given their portfolios and footprints, these five companies – Cipla, Hikma, Sun Pharma, Teva and Viatris – can have a huge impact on access in LMICs. They can now work to significantly enhance their efforts by acting on the opportunities and the tailored recommendations set out in their respective company profiles. The report highlights untapped potential for companies to register more essential products in low- and middle-income countries (LMICs). Promisingly, in 90 out of 108 countries in scope, at least one company has registered a product, which indicates that the companies’ existing regulatory reach in LMICs is collectively broad. In March 1996, Ciba-Geigy and Sandoz merged, forming Novartis, a separate company with pharmaceutical and agrochemical operations.

Additionally, the company expanded its portfolio through theacquisition of the US generic prescription product portfolio of Australia-basedMayne Pharma Group Limited. Thecompany exhibits a robust presence in intricate generics such as injectablesand respiratory inhalers. Its generic offerings span various therapeuticdomains, including cardiovascular, central nervous system, oncology, infectiousdiseases, pain management, and respiratory ailments.

• Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.
• Established Pharmaceutical Products, Diagnostic Products, Nutritional Products, and Medical Devices are the four reportable segments for Abbott.
• The company operates across various regions, including Sub-Saharan Africa, South East Asia, Latin America, Eastern Europe, Western Europe, and the Commonwealth of Independent States.
• Asthe 10th largest generics company in the United States, Sun Pharma possesses aformidable research and development infrastructure, equipped to developtechnologically advanced products in both generics and specialty segments.
• They specialize in the development, manufacturing, and marketing of high-quality pharmaceuticals for various medical conditions.
• Laurus Labs is an innovative company with world-class research capabilities, specializing in the manufacturing and marketing of pharmaceutical products.
• It’s more than the transactional relationship of selling drugs at volume and competing on price.
• Headquartered in Israel, the company holds the top spot in revenue and maintains a robust presence in both developed and emerging markets.
• Some amendments, such as the US Generic Drug User Fee Act, are expected to result in a much stronger focus on quality with a much shorter approval process for these generic medicines.

Whether working with small start-ups or large enterprises, Anil consistently delivers high-quality research that supports informed decision-making and drives impactful results in the healthcare industry. Aurobindohas garnered approvals for sophisticated injectable suspension products,including generic versions of Kenalog®, Depot-Medrol®, and Depo-Provera®,typically characterized by an extended duration of action lasting up to severalweeks. Discover the top human resources software companies offering innovative solutions for workforce management, including Workday and BambooHR. The Nutritional Products segment encompasses a vast range of pediatric and adult nutritional items that are developed, marketed, and sold all over the world. Abbott-owned distribution centers or third-party distributors advertise and sell these items directly to customers, institutions, wholesalers, retailers, health care facilities, government organizations, and third-party distributors.

With a portfolio comprising over 200 brands across26 therapeutic categories, the generics segment has achieved remarkable 9%growth, driven by the robust performance of flagship brands and successfullaunches of new products. AurobindoPharma Limited, headquartered in Hyderabad, India, stands as a leading globalpharmaceutical entity renowned for its expertise in manufacturing both genericformulations and active pharmaceutical ingredients (API). With a strategicemphasis on crafting intricate pharmaceutical products for global markets,Aurobindo specializes in tackling complex and challenging manufacturingprocesses.

Viatris seeks to provide improved access to inexpensive, high-quality medications for patients worldwide, regardless of region or circumstance, by combining the assets of these two businesses. Laurus Labs is an innovative company with world-class research capabilities, specializing in the manufacturing and marketing of pharmaceutical products. Laurus Labs is committed to developing new cures, building a profitable business, and improving the quality of life through affordable medicines. The success of these top companies can be attributed to several shared elements and approaches. Firstly, they have invested heavily in research and development, constantly striving to bring new and improved generic drugs to the market.

The inception of generic medicine in India dates back to the post-independence era in 1947 when the pharmaceutical landscape was dominated by foreign companies, holding over 90% of the market share. Despite this foreign dominance, India has emerged as a significant global player in the generic medicine market, marking key milestones revolade price philippines in its history. Driven by Knowledge and Services, InviMeds to become essential to its customers by providing access to most advanced treatment medicines and related services to help improve people’s quality of life. Recent studies reveal concerning trends in the availability and pricing of generic drugs for Hepatitis B and C.

The FDA generic drug program conducts a thorough review before approving the medicines to ensure they meet these requirements. In the event of negative reactions or patient side effects resulting in the report, the FDA investigates and makes required changes in the usage and manufacturing of these medicines. These medicines cost less than branded medicines as they do not involve repeated animal and clinical studies required for branded medicines. However, the issue of these medicines in certain countries is about something other than being expensive but about dubious quality.

Oxialfarm aims to contribute to the social and economic stability of its workforce and achieve significant growth in the local market. By producing bioequivalentversions of brand-name medications, generic drug companies dramatically reducecosts while maintaining the same therapeutic efficacy. This democratization ofmedicine ensures that essential treatments—from antibiotics to cardiovasculardrugs—are not reserved solely for the privileged few but are accessible to allwho need them. It’s a cornerstone of healthcare equity, leveling the playingfield and empowering individuals to take charge of their health without theburden of financial strain.

As Indian companies continue to invest in R&D, they are poised to play an even more substantial role in shaping the future of the global pharmaceutical landscape. Indian pharmaceutical companies are not merely suppliers of generic drugs but have also become significant players in the global pharmaceutical market. These firms are expanding their global footprint through strategic partnerships, acquisitions, and collaborations. By establishing a presence in diverse markets, they contribute to healthcare access and the overall economic development of their regions.

Ratiopharm is a pharmaceutical company that offers a wide range of prescription and over-the-counter medications, as well as generic versions of existing drugs. In India, for example, the ‘Pradhan Mantri Bharatiya Janaushadhi Pariyojana’ scheme is pivotal in the nation’s efforts to increase the domestic availability of low-cost generics. Under this initiative, the government has set up thousands of Janaushadhi Kendras (generic drug stores) to ensure that citizens have access to a wide range of medications at a fraction of the branded drug cost. However, maintaining stringent quality control standards remains a key focus to foster trust and sustained use of these generics. We’re able to make these medicines affordable because we manage the entire value chain – from producing the active ingredients to developing formulations to distributing them through our streamlined supply chain.

Generic medicines play a vital role in enhancing healthcare accessibility, particularly in low- and middle-income countries where financial constraints hinder access to essential treatments. Their cost-effectiveness serves as a practical solution, bridging the availability gap between developed and developing nations. Additionally, by enabling broader production and distribution, generic drugs help alleviate medicine scarcity in underserved regions, contributing significantly to global health equity and addressing healthcare disparities worldwide. The quality issues of generic drugs are another significant challenge to the global market growth. To get approval from the Food and Drug Administration (FDA), generic medicines should be demonstrated to be the same as brand-name medicines in dosage, effectiveness, strength, safety, quality, stability, and how they are taken.

Their responsibilities include compliance with health, safety, and regulatory standards, and ensuring the efficacy and quality of the products. The industry plays a crucial role in enhancing global healthcare systems, offering affordable alternatives to more expensive branded drugs. Future growth and expansion of the industry are projected due to factors such as growing drug patent expiracies and an increasing emphasis on cost-effective healthcare solutions. The generic drugs industry is a sector that focuses on the production and distribution of medications that are bioequivalent to brand-name drugs but are sold under their generic names. There are several types of companies in this industry, including large multinational pharmaceutical companies, smaller local manufacturers, and distributors.