List of APIs/Active Pharmaceutical Ingredients Companies with Phase 4 Active Clinical Trial - 12

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Amneal Pharmaceuticals Inc.

Amneal Pharmaceuticals Inc.

Bridgewater, New Jersey, United States of America

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.

Cipla

Cipla

Mumbai, India

Cipla is a leading global pharmaceutical company trusted by healthcare professionals and patients across the world since 1935. A compassionate approach to healthcare that goes beyond the pursuit of profit and growth has been the force impelling Cipla’s history over the years. Our credo and our purpose of ‘Caring for Life' continues to guide our actions towards our people and the planet for creating a sustainable future. Cipla today has presence in 80+ countries, providing over 1,500 products across various therapeutic categories in 50+ dosage forms. Keeping with our legacy of care, we constantly strive to ensure access to high-quality medicines that make a difference in the lives of patients. Our paradigm-changing offer of a triple anti-retroviral (ARV) therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 was pivotal in bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. An unmatched presence across the care continuum (awareness, prevention, diagnosis, treatment and adherence) and the widest range of drug-device combinations has established Cipla’s respiratory leadership in India and other key emerging markets. Armed with this legacy and a deep understanding of the lungs, we have articulated our aspiration to become a global lung leader and help millions breathe free.

CSPC Pharmaceutical Group

CSPC Pharmaceutical Group

276 zhongshan west road, shijiazhuang shi, hebei sheng, china

CSPC Pharmaceutical Group Limited is a leading pharmaceutical company based in Shijiazhuang, Hebei, China. The company focuses on the research, development, manufacture, and sale of a wide range of pharmaceutical products. With a strong emphasis on innovation, CSPC has a robust research and development team of over 2,000 members, including many with advanced degrees and international experience. Their R&D efforts span multiple locations, including Shijiazhuang, Shanghai, Beijing, and the United States. CSPC offers a diverse array of pharmaceutical products, including finished drugs like capsules, tablets, and injections, as well as bulk drugs such as active pharmaceutical ingredients. Their product range addresses various therapeutic areas, including oncology, cardiovascular health, respiratory conditions, anti-infectives, and diabetes management. The company also has an extensive pipeline of over 300 projects focused on innovative drug development, highlighting its commitment to advancing healthcare solutions. CSPC's products are available in multiple regions, including the Americas, Europe, and Asia, serving a broad customer base in the healthcare sector.

entrinsic bioscience

entrinsic bioscience

100 River Ridge Drive, #206, Norwood, MA 02062, US

Entrinsic Bioscience is a biotechnology company that specializes in developing functional ingredients and Active Pharmaceutical Ingredients (APIs) through a proprietary platform centered on amino acid combinations. The company utilizes a biomapping and electrophysiology platform to identify and patent specific amino acid combinations that influence protein regulation and cell signaling. This technology has its origins in research conducted with NASA, aimed at addressing gastrointestinal damage from ionizing radiation during deep space missions. The company offers a range of applications, including products for pulmonary health, digestive health, immune regulation, metabolism, hydration, and skin health. One of its notable products is enterade IBS-D, a non-prescription medical food designed to manage symptoms of IBS-D. Entrinsic collaborates with healthcare providers, academic institutions, and global partners to commercialize its formulations, focusing on science-backed, plant-based solutions that enhance health outcomes.

Givaudan

Givaudan

Geneva, Switzerland

Givaudan is a global leader in Fragrance & Beauty and Taste & Wellbeing. We celebrate the beauty of human experience by creating for happier, healthier lives with love for nature. Together with our customers we deliver food experiences, craft inspired fragrances, and develop beauty and wellbeing solutions that make people look and feel good. With over 163 locations in 52 countries and over 78 production sites, of which 31 are located in Europe, 22 in North America, 17 in Latin America, 8 in Asia-Pacific, and 1 across South Asia, the Middle East, and Africa, we are committed to driving purpose-led growth that makes a positive impact. Givaudan: Human by nature. www.givaudan.com

Insud Pharma

Insud Pharma

Calle Manuel Pombo Angulo, 28, Madrid, Madrid 28050, ES

INSUD PHARMA operates across the entire pharmaceutical value chain, delivering specialized expertise and experience in scientific research, development, manufacturing, sales and marketing of a wide range of value-adding active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceuticals, for human and animal health. While the main offices are located in Madrid, Lugano, Buenos Aires, INSUD PHARMA is acting worldwide, creating a broad and balanced manufacturing and commercial network across Europe, America, Asia and Africa, to address global opportunities and customers`​ needs in all major pharmaceutical markets. INSUD PHARMA's activity is organized in three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotech (mAbxience), with over 7,300 professionals in more than 50 countries, 18 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices and more than 35 pharmaceutical affiliates, serving 1,150 customers in 96 countries around the world. INSUD PHARMA believes in innovation and sustainable development. Our commitment is to improve people`s health and quality of life, providing access to quality medicines at affordable prices, and to continuously expand our efforts and R&D investment to develop new and better therapies.

Italfarmaco

Italfarmaco

Alcobendas, Madrid, Spain

Italfarmaco, one of the leading Italian pharmaceutical groups, operates in both the pharmaceutical and the fine chemical industries. The company was founded in Milan in 1938. The Italfarmaco Group now markets ethical products in Italy, Spain, Portugal and Greece, where it employs a workforce of over 1400 and has a total turnover exceeding 300 million euros. Its products, all of which have a high therapeutic content, are mainly used in the cardiovascular, immuno-oncological, gynaecological, dermatological, orthopaedic and neurological areas.

Jeil Pharmaceutical

Jeil Pharmaceutical

Seoul, Korea

Jeil Pharmaceutical - Founded in 1959, Jeil has developed and supplied superior pharmaceutical products to promote the happiness and health of mankind and has contributed to the growth and development of the pharmaceutical industry in Korea. Jeil has been listed on KOSPI since 1988. As of 2018, Jeil is constituted of 1143 employees and has sales amount reaching above 680 billion Korean wons. The Central R&D Center established in 1980 forms the core of the R&D activities of Jeil. Currently, as of 2018, the new drug development laboratory, the pharmacology & toxicology laboratory, the organic synthesis laboratory, the formulation laboratory, and the analysis laboratory are actively engaged in conducting research into the complete manufacture and ingredients of innovative new drugs, incrementally modified drugs, and generic drugs. Jeil’s factory established in 1986 and located in Yongin-si, Korea was accredited as fulfilling KGMP in 1987, and produces tablets, capsules, injections, finished pharmaceutical products including patches, and Active Pharmaceutical Ingredients(APIs) such as anti-biotic ingredients, etc. The construction of new factory with the most up-to-dated facilities, which complies with EU-GMP and US-GMP, has been completed in 2016. In May of 2018, Jeil established Pharmaceutical Technology Research Institute, a formulation and analysis lab, at Yongin Technovalley in Yongin-si, Korea to further improve and invest in research and development of Incrementally Modified Drug (IMD) and generic products. Jeil, equipped with global-class research centers and production facilities, has been recognized for its outstanding value on the world market as well. In the ingredients sector, Jeil exports synthetic ingredients such as Cefditoren Pivoxil, Epinastine HCl, etc. to Japan and China, while also supplies finished products such as Kefentech Plaster (Ketoprofen), Cilapenem Injection (Imipenem / Cilastatin Sodium), etc. to more than 40 countries in ASEAN, Central and South America, Africa, etc. Within the South Korean market, Jeil operates a well-trained MR organization to cover the nation-wide market based on science and evidence, and thereby has become a supplier of over 70 prescription drugs and over 30 over-the-counter drugs. Beginning in the period between 1970 and 1980, Jeil has engaged in technological partnerships (licensing) with global pharmaceutical companies to provide the domestic market with outstanding new drugs. It has also been the first Korean company to engage in co-promotion successfully with the globally renowned company Pfizer, executing a win-win strategy with our overseas collaborative partners and thus winning recognition as an advanced pharmaceutical company adapted to internationalized business practices. We thank all of the visitors to our Jeil’s homepage for their interest and encourage you to contact us for further business progress.

Novaliq

Novaliq

Heidelberg, Germany

Novaliq is a pharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the first water-free technology worldwide for ophthalmology products. With an initial focus on dry eye disease (DED), Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye disease. With an initial focus on dry eye disease (DED), Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye disease. NOV03 and CyclASol® are the two late stage development compounds. NOV03 is the first drug developed to treat evaporative DED associated with meibomian gland dysfunction in a highly effective way. CyclASol®, an ophthalmic solution of 0.1% cyclosporine A in EyeSol®, is an anti-inflammatory and immunomodulating drug for the treatment of aqueous deficient DED. Both compounds have shown superior clinical benefit, with an onset of action and an excellent tolerability profile. NovaTears® water-free eye drops for dry eye disease have CE certification and are commercialized in Australia/New Zealand by AFT Pharmaceuticals and in Europe as EvoTears® by Ursapharm. Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech Holding, an active investor in Life and Health Sciences companies.

Qilu Pharmaceuticals

Qilu Pharmaceuticals

243 Gong Ye Bei Road, Jinan City, Shandong Province 250100, CN

Qilu Pharmaceuticals is a leading Chinese pharmaceutical company founded in 1958, recognized as one of the top three players in China's pharmaceutical industry. The company operates as a vertically integrated enterprise, focusing on human medicines, veterinary medicines, and crop protection products. It has 12 subsidiaries and 11 manufacturing sites across China. Qilu's product portfolio includes over 300 finished dosage forms, making it a prominent manufacturer of injectables and solid-dose medications. The company also produces a wide range of active pharmaceutical ingredients (APIs) and has a robust pipeline with more than 200 generic drugs, 20–30 biosimilars, and 80–90 innovative drugs in development. With a global reach, Qilu exports products to over 100 countries and has established subsidiaries in the U.S., Europe, and Brazil. The company employs over 39,000 people worldwide, with a strong emphasis on affordable medicines and improving global health.

SUN PHARMA

SUN PHARMA

Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is a prominent global pharmaceutical company based in India. Established in 1983, it has grown to become the largest pharmaceutical company in India and the fifth-largest specialty generic pharmaceutical company worldwide. Sun Pharma specializes in generic and specialty pharmaceuticals, focusing on chronic therapies in areas such as cardiology, psychiatry, neurology, gastroenterology, and oncology. The company operates in over 100 countries, with significant markets in the U.S., India, and emerging economies. Sun Pharma produces a diverse range of off-patent generic drugs, including tablets, capsules, injectables, and topical formulations. It also develops complex generics and specialty products for various conditions. The company has a strong commitment to research and development, investing in novel drug delivery systems and biosimilars. With 43 manufacturing facilities across five continents and a workforce of over 37,000, Sun Pharma continues to expand its global footprint and enhance its product offerings.

Yuhan Corporation

Yuhan Corporation

74 Noryangjin-ro, Dongjak-gu, Seoul Teugbyeolsi, KR, 06927

Yuhan Corporation is an integrated healthcare company founded in 1926. It has achieved top market value and sales revenue in Korean pharmaceutical industries, and been awarded for the most respected and trusted company in Korea for recent 11 consecutive years. It has two subsidiaries, Yuhan Chemical and Yuhan Medica, and the affiliates including Joint Ventures with Janssen(Belgium), the Clorox Company(USA), and Kimbery-Clark Corporation(USA). The core business of Yuhan can be classified into Primary & Specialty care, Dietary supplement, Household & Animal care, and contract manufacturing of active pharmaceutical ingredients.