List of Generics Companies with Phase 3 Active Clinical Trial - 15

Partner of choice in specialty, hospital, and rare disease medicines ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

四川百利天恒药业股份有限公司 百利药业是一家集研发、生产、营销为一体的现代化高新技术企业。拥有2个新药研发中心、1个抗体及ADC药物生产企业、1个化学中间体生产企业及1个化学原料药生产企业、2个化学。

Biocon: Enhancing Global Healthcare Biocon Limited, publicly listed in 2004, is India's largest and fully-integrated, innovation-led biopharmaceutical company. It is an emerging global biopharmaceutical enterprise serving customers in over 120 countries. Driven by a vision to enhance global healthcare through innovative and affordable biopharmaceuticals, we have enabled access to advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high. The early anticipation of the increasing dominance of biologics in global development pipelines helped us to be ahead of the curve in crafting a differentiated product portfolio based on fermentation and recombinant technologies, which straddles fermentation-derived small molecules and biologics, both novel as well as biosimilars. The significant brand equity that we have built worldwide for our small molecule APIs across statins, immunosuppresants and other specialty products has made us a leading global supplier of these products. We have also built one of the largest and most diverse biosimilar pipelines, spanning insulins, monoclonal antibodies and other recombinant proteins that address critical chronic diseases such as diabetes, cancer and autoimmune disorders. Ranked among the Top 3 biosimilar players globally for rh-insulin and insulin glargine in volume terms, we are the first Indian company to launch a biosimilar in Japan with Insulin Glargine, which also has been approved for sale in EU and Australia. Our insulin products have made a difference to the lives of millions of people with diabetes across the globe. We now aim to provide our insulin products to ‘one in five’ people with diabetes in need of insulin-based therapy anywhere in the world within the next 10 years. We are also making a huge impact in the area of cancer care. Our biosimilar Trastuzumab, which was the first to be approved anywhere in the world and launched in India in 2014, has helped treat several thousand HER2-positive metastatic breast cancer patients. We are also the first company from India to get its biosimilar approved by the USFDA; Ogivri™, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in the US. In addition to Trastuzumab, several of our biosimilar assets are on track for anticipated regulatory approvals in developed markets. We are also developing a pipeline of patented biologics to address global unmet medical needs. We have successfully launched a couple of novel biologics in India: Nimotuzumab for the treatment of head and neck cancer and Itolizumab to tackle psoriasis. Besides these, we have a basket of novel assets are under various stages of clinical development, including a high potential oral insulin. Through our subsidiary, Syngene, we offer a suite of integrated, end-to-end discovery and development services for novel molecular entities (NMEs) to the global life sciences sector. Ranked by the prestigious Science magazine among the Top 10 Best employers in the biotech industry, Biocon is passionately pursuing a mission to rationalize healthcare spends, enhance access to life-saving therapies and make a significant impact to global healthcare through ‘blockbuster’ drugs with the potential to benefit a billion patients.

Chengdu Kanghong Pharmaceutical Group Co., Ltd. is a publicly traded pharmaceutical company based in Chengdu, Sichuan Province, China. Founded in 1996, it is listed on the Shenzhen Stock Exchange and employs over 4,000 people worldwide. The company specializes in the research, development, production, and distribution of pharmaceuticals and medical devices, adhering to international quality standards with GMP-certified manufacturing facilities. Kanghong focuses on several therapeutic areas, including ophthalmic care, central nervous system treatments, and medications for digestive and endocrine systems. Its product offerings include chemical drugs, traditional Chinese medicines, and biological products. The company operates in over 12 countries and territories, emphasizing global expansion and maintaining strong in-house R&D capabilities. Kanghong is committed to advancing medical innovation through academic and scientific communication.

CinnaGen is an Iranian biotechnology company founded in 1994 and headquartered in Tehran. It is recognized as a leading biopharmaceutical manufacturer and exporter in the Middle East and North Africa (MENA) region. The company adheres to modern quality standards and complies with Good Manufacturing Practice (GMP) regulations for food and pharmaceutical products. CinnaGen offers contract development and manufacturing services, supporting the development of biopharmaceutical products. The company specializes in biosimilars, particularly for immunological diseases, infertility, hormone disorders, and oncology. Notable products include Cinnovex, a biosimilar for multiple sclerosis, as well as therapeutic recombinant proteins, molecular diagnostic kits, and synthetic peptides. CinnaGen's products are exported to various countries, aiming to enhance patient outcomes in the healthcare sector. The company has achieved significant milestones, including being the first in the MENA region to manufacture Taq DNA polymerase and monoclonal antibodies, and it has received GMP certification from the European Medicines Agency for its biologic plant.

Eusol Biotech was founded in March 2005 in Taipei, Taiwan. The company is involved in the R&D and GMP process development of recombinant human acid fibroblast.

Hyundai Pharm is eager to share our happiness to all of you. Our all executives and staffs have been building up happiness in Hyundai Pharm as if we are a family. Through this inside circumstance, we are performing moral and qualified management to make all costumers be satisfied with us. Moreover, we have tried to carry out social responsibility with conducting social-minded activities consistently to make the sociality be more peaceful and attractive. We are now going to the next step for the global company. Fear for the changes could be hard to expect for better tomorrow. Hyundai Pharm has been growing up for the best pharmaceutical company in the world through our vision that is “going to the next step with changes and innovation.” For that reason, we are focusing on R&D more to make a new product which contributes to the everyone’s happiness, and eager to be a leading company with our speedy sharing of information and decision. We firmly promise that we will be the best pharmaceutical company in the world in spite of the rapidly changing management circumstances and do our best to achieve our goal.

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing organization in the world. It has been growing at 19% CAGR and crossed the $2.5 billion mark in the past financial year. The company has set up a network of subsidiaries, under the name Accord Healthcare in the EU, US, Canada, SA, Australia, APAC as well as CIS & MENA regions. Intas is present in 85+ countries, with more than 70% of its revenue coming from global business. Currently ranked 6th in the Indian pharmaceutical market, it’s the largest privately owned Indian generic pharma company. Intas has established leadership in key therapeutic segments like CNS, Cardio, Diabeto, Gastro, Urology, Oncology & Animal Health in India. We are among the top 10 generic players in the highly regulated markets of EU, US & UK. Intas operates 17 advanced formulations, R&D, and distribution facilities, of which 10 are in India and the rest in the UK, Mexico & Greece with the help of our 23,000+ Human Capital. Between them, the facilities are accredited by global regulators such as USFDA, EMA, MHRA, TGA, and others. The company invests ~6-7% of its revenues in R&D and has over 10,000 product registrations worldwide with a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars, and NDDS products. Intas' highly advanced EU-GMP Certified Biopharma division is fueled by a mission to provide affordable “Biosimilars for Billions” across niche segments such as oncology, auto-immune, ophthalmology, nephrology, rheumatology, and hormone-based therapies. The Plasma Fractionation Unit of Intas Pharmaceuticals is a pioneer in manufacturing plasma-derived therapeutics. It houses a full-fledged R&D lab and a state-of-the-art WHO-GMP-certified manufacturing facility complemented with a GLP-compliant QC lab. Our values of Innovation, Customer Delight, Ownership & Collaboration, Performance Focus & Care for Society are the driving forces toward excellence.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Develop and market generic and biosimilar drugs. Locations throughout the world.

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

海思科医药集团成立于2000年，是一家以新药研发为核心，销售能力特别突出的医药类集团化上市公司。集团是肠外营养行业领导者，在肝病领域细分市场占据重要地位，是全国排名前列的肝病用药生产销售基地，现有员工超过1900名。 公司自2012年1月17日在深圳证券交易所A股上市以来，在资本市场有着良好的表现，目前股票市值约270亿人民币，A股排名前380、中小板排名前59、全国医药上市公司中长期排名25、化学药子行业上市公司排名第7 位、上市公司市值管理绩效百佳榜第9位、中国上市公司市值管理绩效百佳、中国医药行业最具影响力榜单成长50强企业、2014福布斯中国上市潜力企业100强位列第三位、医药类企业第一位、2015福布斯中国潜力企业。 公司坚持以新产品研发作为企业发展的核心驱动力，经过多年积累与实践，公司已建立450人的研发团队，其中包括50余名博士、近百名硕士，95%以上成员具有药学或相关专业本科以上学历，公司研发团队技术水平、团队人数在国内医药企业处于领先水平，公司首仿成功率行业第一，近五年新药批件取得数量全国第三。 公司于2015年正式进军高端医疗器械市场。

Was established in 1993 and is headquartered in the core area of ​​the Eastern Smart City of Guangzhou, covering an area of ​​50,000 square meters. It is the world's leading bioprotein biopharmaceutical company, focusing on the sales and development of biopharmaceuticals in the field of critical illness. and production. The company adheres to the core values ​​of "integrity, integrity; passion, perseverance; commitment, efficiency; care, participation; innovation, learning; cooperation, communication", and owns the national Class II new drug (domestic exclusive variety) Templuoan® (urinol for injection) The company has the exclusive distribution rights in mainland China for the world's first Class 1 new drug Kailikan® (Eurexalin for injection), and the first-line drug Bonroli (ibandronic acid injection) in the field of tumor bone metastasis treatment.

Wockhardt is a global pharmaceutical and biotechnology organization, providing affordable, high-quality medicines for a healthier world. It is India’s leading research-based global healthcare enterprise with relevance in the fields of Pharmaceuticals, Biotechnology and a chain of advanced Super Specialty Hospitals. Wockhardt is a true Indian Multi-National Company with a multi-ethnic workforce of 3000 Wockhardt Associates from 21 different nationalities globally. It has 3 research centers and 12 manufacturing plants, with businesses ranging from the manufacture and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines. Headquartered in Mumbai, India, Wockhardt has full-fledged operations in the USA, UK, Ireland and France. It also has its marketing presence in emerging markets of Russia, Brazil, Mexico, Vietnam, Philippines, Nigeria, Kenya, Ghana, Tanzania, Uganda, Nepal, Myanmar, Sri Lanka, Mauritius, Lebanon and Kuwait. Wockhardt’s core business is innovation. It uses science and technology to develop medicines and other products that improve the quality of millions people’s lives through better health. Wockhardt aspires to create a healthier world. Its strategic vision of ‘More & More with Less & Less’ has transformed into new ways of thinking, a new journey for growth, medical breakthroughs for patients and continuing value for all stakeholders.