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    • Small logo of Teva Pharmaceutical Industries

      Teva Pharmaceutical Industries

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IsraelIsrael

      Sites

      Flag of IndiaIndia
      Flag of SpainSpain
      Flag of NetherlandsNetherlands
      Flag of PolandPoland
      Flag of Czech RepublicCzech Republic
      Flag of IsraelIsrael
      Flag of HungaryHungary
      Flag of ItalyItaly
      Flag of CroatiaCroatia
      Flag of MaltaMalta
      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of Puerto RicoPuerto Rico
      Flag of MexicoMexico
      Flag of United States of AmericaUnited States of America
      Flag of GermanyGermany
      Flag of LithuaniaLithuania
      Flag of United KingdomUnited Kingdom
      Flag of IrelandIreland
      Flag of CanadaCanada

      Regulatory compliance

      EDQM
      WHO GMP
      FDA
      JDMF
      KDMF
      GDUFA
      EU WC
      GDP
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (Finished Dosage)
      Sterile FDF
      GMP (APIs)

      Company description

      TAPI stands as the primary global provider of active pharmaceutical ingredients (APIs). With the most extensive range of over 370 high-caliber API products in the industry, we cater to almost 1,000 clients across more than 100 nations. Operating as an independent division under Teva Pharmaceutical Industries, our legacy in the generic API sector spans over 80 years. Situated in close proximity to Tel Aviv, Israel, TAPI boasts a workforce of over 5,000 professionals spread across 19 facilities worldwide. Our cutting-edge manufacturing plants are situated in Italy, Hungary, the Czech Republic, Croatia, Israel, India, China, Mexico, and several other locations.

    • Small logo of Sicor

      Sicor

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly
      Flag of MexicoMexico
      Flag of GermanyGermany
      Flag of LithuaniaLithuania
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      JDMF
      KDMF
      FDA
      GDUFA
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Sicor, situated in the northern region of Italy, is a component of the Teva API business and offers a worldwide platform for the production and promotion of APIs for injectable, inhalation, topical, and nasal products. These specialized facilities possess a significant level of skill, manufacturing approximately 60 active pharmaceutical ingredients.

    • Small logo of Jiangsu Hengrui Pharmaceuticals Co., Ltd

      Jiangsu Hengrui Pharmaceuticals Co., Ltd

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      GMP
      EDQM
      JDMF
      FDA
      KDMF
      GDUFA
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Hengrui Medicine is a prominent pharmaceutical corporation situated in China, focusing on the exploration, production, manufacturing, and marketing of groundbreaking and superior healthcare goods. It underwent restructuring into a joint-stock company in 1997 and was subsequently listed on the Shanghai Stock Exchange under stock code 600276 in 2000. With a market capitalization exceeding 55 billion USD, the company is ranked among the top 30 pharmaceutical firms globally and employs over 21,900 personnel worldwide. Hengrui is recognized as a pioneer in the field of cancer medications, contrast agents, and surgical innovations.

    • Small logo of Zhejiang Hisun Pharmaceutical Co., Ltd

      Zhejiang Hisun Pharmaceutical Co., Ltd

      Manufacturer
      Audited
      Audit report available
      Non-Compliance Report

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of People's Republic of ChinaPeople's Republic of China
      Flag of JapanJapan

      Regulatory compliance

      EDQM
      GDUFA
      CE
      KDMF
      FDA
      JDMF
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Founded in 1956, Zhejiang Hisun Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise featuring whole chain, multi-regional integration of research, production and marketing as well as development of drug substances and preparations. In 2000, an A-share was issued in order to enter the stock market as a state-owned listed company. As of 2021, Hisun Pharmaceutical is now one of the largest producers of antibiotics and anti-tumor drugs in China and has been listed in the Top 500 Chinese manufacturing enterprises and the Top 100 Chinese pharmaceutical enterprises multiple times. In 2020 Hisun Pharmaceuticals received special recognition from the Joint Prevention and Control Team from the State Council of the People’s Republic of China for their extraordinary efforts in the fight against the epidemic, and Hisun Pharmaceutical was awarded with the “Anti COVID-19 Advanced Collective in Ministry of Industry and Information Technology".

    • Small logo of Qilu Pharmaceutical

      Qilu Pharmaceutical

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      EDQM
      KDMF
      JDMF
      FDA
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Established in 1958, Qilu Pharmaceutical is now one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures and distributes both Finished Dosage Forms (FDFs) and Active Pharmaceutical Ingredients (APIs). Qilu currently has 12 subsidiaries, 11 domestic manufacturing sites and over 3,9000 employees worldwide. Qilu ranks among Top 5 in Chinese pharmaceutical industry in 2022. Dedicated to offering high-quality & trustworthy medicines to the world and improving people‘s well-being, Qilu is vigorously exporting its products to over 100 countries and regions around the world.

    • Small logo of MSN Life Sciences Pvt. Ltd.

      MSN Life Sciences Pvt. Ltd.

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      EU WC
      GDUFA
      KDMF
      JDMF
      FDA
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible.

    • Small logo of Intas Pharmaceuticals

      Intas Pharmaceuticals

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of United KingdomUnited Kingdom
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      EDQM
      WHO GMP
      KDMF
      EU WC
      GDUFA
      FDA
      USDMF
      CEP COS

      Audit standards

      GMP (Finished Dosage)

      Company description

      Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world. Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown both organically and via acquisition, expanding its product portfolio and operations year on year. It is currently present in more than 85 countries worldwide with robust sales, marketing and distribution infrastructure in markets like North America, Europe, Central & Latin America, Asia-Pacific as well as CIS and MENA countries. Intas’ remarkable success in North America and European operations have helped us emerge as a global brand in the world’s largest pharmaceutical markets.

    • Small logo of Cdymax

      Cdymax

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EU WC
      USDMF
      CEP COS
      NDC API
      KDMF
      JDMF

      Company description

      Cdymax (India) Pharma Private Limited was established in 1994. The organization's primary function involves the production, construction, or transformation of medications in pharmaceutical formulations for either human or veterinary application. CDYMAX guarantees and complies with HSE guidelines. Systems and protocols are implemented to oversee and regulate. All staff members undergo routine health assessments annually, and twice a year for oncology personnel. The wastewater treatment facility meets governmental standards.

    • Small logo of Viatris

      Viatris

      Manufacturer

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of CanadaCanada
      Flag of IrelandIreland
      Flag of IndiaIndia
      Flag of PolandPoland
      Flag of Puerto RicoPuerto Rico
      Flag of AustraliaAustralia

      Regulatory compliance

      WHO GMP
      FDA
      GDUFA
      EDQM
      GDP

      Company description

      VIATRIS™ represents a fresh approach to healthcare, dedicated to ensuring medicine accessibility, promoting sustainable practices, pioneering creative remedies, and enhancing patient results. Founded in 2020 through the merger of Mylan and Upjohn, Viatris unites top-notch scientific, production and distribution skills with established regulatory, medical and commercial proficiencies.

    • Small logo of Dr. Reddy's Laboratories

      Dr. Reddy's Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of MexicoMexico
      Flag of United KingdomUnited Kingdom
      Flag of United States of AmericaUnited States of America
      Flag of RomaniaRomania

      Regulatory compliance

      EDQM
      GDUFA
      EU WC
      JDMF
      FDA
      KDMF
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
      GMP (Excipients)

      Company description

      Dr. Reddy’s Laboratories Ltd. functions as an integrated pharmaceutical firm, dedicated to supplying cost-effective and innovative medications to promote healthier lifestyles. With a focus on Pharmaceutical Services & Active Ingredients, Global Generics, and Proprietary Products, Dr. Reddy’s delivers a range of products and services such as APIs, customized pharmaceutical services, generics, biosimilars, and distinct formulations. The primary therapeutic areas of concentration encompass gastro-intestinal, cardiovascular, diabetology, oncology, pain management, and dermatology. Dr. Reddy’s has a presence in various global markets, with significant engagements in the USA, Europe, India, Russia, and other CIS nations.

    • Small logo of Sun Pharmaceutical Industries

      Sun Pharmaceutical Industries

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of AustraliaAustralia
      Flag of IndiaIndia
      Flag of NetherlandsNetherlands
      Flag of United States of AmericaUnited States of America
      Flag of United KingdomUnited Kingdom
      Flag of HungaryHungary
      Flag of IsraelIsrael
      Flag of IrelandIreland
      Flag of CanadaCanada

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      FDA
      KDMF
      EU WC
      GDP
      JDMF
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Sun Pharma is a global, comprehensive, specialized pharmaceutical company with production facilities for API and FDF in India, the United States, Latin America, and Europe. It produces and sells a wide range of pharmaceutical formulations as branded generics and generic drugs in India, the US, and various other global markets. It is supported by 2 advanced R&D Centers with a team of over 600 scientists for projects in Chemical Synthesis, Clinical Research, and formulation development. Sun is a frontrunner in specific therapy areas and possesses robust expertise in product development, process chemistry, and manufacturing.

    • Small logo of Cipla

      Cipla

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of NetherlandsNetherlands
      Flag of United KingdomUnited Kingdom
      Flag of BelgiumBelgium
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      EU WC
      FDA
      KDMF
      JDMF
      GDP
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (Finished Dosage)

      Company description

      Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of Caring for Life and deep-rooted community links wherever it is present, make it a partner of choice for global health bodies and stakeholders.

    • Small logo of Hetero Drugs

      Hetero Drugs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of MaltaMalta

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      EU WC
      FDA
      KDMF
      JDMF
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)

      Company description

      We are one of world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector. We endeavour to serve patients by moulding science and technology into therapies to improve health outcomes and people’s lives.

    • Small logo of Fareva

      Fareva

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
      Flag of GermanyGermany
      Flag of SwitzerlandSwitzerland
      Flag of United States of AmericaUnited States of America
      Flag of AustriaAustria

      Regulatory compliance

      EDQM
      GDUFA
      CE
      GMP
      JDMF
      KDMF
      FDA
      GDP
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (Finished Dosage)

      Company description

      FAREVA stands as a prominent global pharmaceutical CDMO with leading expertise in the development and production of a wide variety of Drug Products and Active Pharmaceutical Ingredients (APIs). The company has a workforce of 13,000 individuals spread across 41 manufacturing facilities situated in 13 countries across EMEA and the Americas. Among these facilities, 18 are exclusively dedicated to pharmaceutical operations. FAREVA’s API division carries out its activities in 3 European locations situated in France and Germany.

    • Small logo of Laurus Labs

      Laurus Labs

      Manufacturer
      Audited

      Sites

      Flag of IndiaIndia
      Flag of United KingdomUnited Kingdom

      Regulatory compliance

      EDQM
      GDUFA
      JDMF
      EU WC
      KDMF
      FDA
      USDMF
      CEP COS
      NDC API

      Company description

      In just over a decade, Laurus has positioned itself as one of the largest and most innovative API producers globally. Expanding upon its established expertise in chemistry, Laurus has recently adopted full vertical integration, including a strong finished dosage capacity, dedicated capacity for backward integration, and also Synthesis R&D operations in India and the USA.

    • Small logo of Shilpa Medicare

      Shilpa Medicare

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of PolandPoland

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      CE
      EU WC
      KDMF
      JDMF
      FDA
      NDC API
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      We specialize in premium Active Pharmaceutical Ingredients (APIs), Formulations, Innovative Drug Delivery Systems, and Specialty Chemicals using advanced technology with precision to adhere to global standards/specifications. Presently, we are recognized as one of the foremost global providers of Oncology/non-Oncology APIs, intermediates, and Formulations. Shilpa Medicare’s establishments have garnered significant regulatory endorsements from USFDA, EUGMP, TGA, PMDA, Cofepris, Anvisa, and KFDA, encompassing diverse regulatory approved manufacturing standards.

    • Small logo of Granules India

      Granules India

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      GDUFA
      EU WC
      KDMF
      FDA
      EDQM
      JDMF
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Granules India Limited is a rapidly expanding pharmaceutical company with top-notch amenities for APIs, PFIs and Finished Dosages, catering to clients in more than 60 nations. We are dedicated to upholding high standards in production, excellence and client relations. Our main office is situated in Hyderabad, and we also have branches in the United States, United Kingdom, Colombia and China, as well as production facilities in India and China.

    • Small logo of Patheon

      Patheon

      Manufacturer
      Audited

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

      Flag of United States of AmericaUnited States of America
      Flag of AustriaAustria
      Flag of CanadaCanada
      Flag of SwitzerlandSwitzerland
      Flag of ItalyItaly
      Flag of United KingdomUnited Kingdom
      Flag of NetherlandsNetherlands
      Flag of FranceFrance

      Regulatory compliance

      EDQM
      FDA
      JDMF
      KDMF
      GDUFA
      GDP
      NDC API
      CEP COS
      USDMF

      Company description

      Committed to excellence, scientific quality, and exceptional client engagement, Patheon is a prominent global supplier of contractual drug development and manufacturing services. With eight centers of excellence for development and thirteen manufacturing facilities spanning North America and Europe, Patheon offers pharmaceutical and biotechnology firms direct access to expertise, quality, and a full range of solid and sterile dosage forms to advance drug candidates from preclinical stages through production, and to introduce products globally.

    • Small logo of Symed Labs

      Symed Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EU WC
      KDMF
      FDA
      EDQM
      GDUFA
      CEP COS
      NDC API
      USDMF

      Audit standards

      GMP (APIs)

      Company description

      Situated in Hyderabad, India, Symed Labs Ltd is a prominent and innovative producer of Active Pharmaceutical Ingredients (APIs) & a comprehensive solution provider for the pharmaceutical sector for chemistry related services. Symed labs has autonomously created processes for more than fifty APIs across various therapeutic categories in the laboratory and upscaled them to plant, as well as vending them to over 600 clients in 30 nations in the regulated and less regulated markets

    • Acebright Group

      Manufacturer

      Headquarters

      Flag of People's Republic of ChinaPeople's Republic of China

      Sites

      Flag of AustraliaAustralia
      Flag of IndiaIndia
      Flag of People's Republic of ChinaPeople's Republic of China

      Regulatory compliance

      EDQM
      WHO GMP
      GDUFA
      EU WC
      KDMF
      JDMF
      FDA
      USDMF
      CEP COS
      NDC API

      Company description

      Shanghai Acebright Pharmaceuticals Group Co Ltd was established in 1996. Over 12 manufacturing facilities conforming to GMP standards are situated in China and India. The company specializes in a range of Vitamin products, ARV APIs & intermediates, and oncology APIs & finished pharmaceutical products. It serves as an integrated CDMO service partner from R&D to commercial manufacturing.

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    Some information included may be sourced from the European Medicines Agency website (https://www.ema.europa.eu/) or the U.S. Food & Drug administration website (https://www.fda.gov/). Please note that Qualifyze does not guarantee the completeness or timeliness of the content. Qualifyze is not liable for any inaccuracies, errors or omissions in the content sourced from such sources.

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