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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 Polpharma Group

      Polpharma Group

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of PolandPoland

      Sites

      Flag of AlbaniaAlbania
      Flag of PolandPoland
      Flag of South KoreaSouth Korea
      Flag of IndiaIndia

      Regulatory compliance

      GMP
      JDMF
      KDMF
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (Finished Dosage)

      Company description

      Polpharma Group serves as a top-tier pharmaceutical manufacturer in Europe and a reliable partner for pharmaceutical firms globally. With a wide range of products (Rx, CHC, APIs), expert services, and competencies across the value chain, along with extensive knowledge of local CEE/CIS markets, it provides distinct growth opportunities for B2B partners. Collaborating with Polpharma Group offers access to a supportive environment, guidance from skilled professionals, and cutting-edge resources. The company actively seeks partners across various areas of operation, from product development and production to commercial cooperation. Additionally, Polpharma API, a Poland-based CDMO specializing in active pharmaceutical ingredients (APIs), stands as a significant European API supplier, catering to pharmaceutical companies worldwide. The company is in the process of a $45 million manufacturing expansion, incorporating HPAPI and cryogenic technologies, with investments in a pilot plant and R&D capabilities. Operations are set to expand from mid-2023, with full completion expected by 2026.

    • Small logo of Aurobindo Pharma

      Aurobindo Pharma

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of NetherlandsNetherlands

      Regulatory compliance

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

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      Founded in 1986 by Mr. P. V. Ramprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and anti-biotics, among others.

    • Hubei Biocause Heilen 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
      GDUFA
      GMP
      KDMF
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Hubei Biocause Group is a public listed company, involves Pharmaceutical, Chemical and new energy fuel. The company is also the biggest share holder of two insurance companies (Life Insurance and Motor Insurance).Biocause’s pharmaceutical part involves Contract Research, Contract Manufacture and production of API, intermediates and formulations, including tablets, granules, capsules and etc.Biocause is one leading pharmaceutical producer and exporter in China, with strong Production, R&D and Quality system. The company has 8 APIs registered in FDA and 4 APIs with CEP. The company has passed US FDA inspections, EU GMP inspection all on first attempts, covering 3 API facilities and multi-APIs, including kilo production site as well as hundreds tons commercial site. The product has been exported to over 85 countries globally and half of them sold into regulatory market as USA and EU.

    • 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 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 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 Olon

      Olon

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly
      Flag of IndiaIndia
      Flag of United States of AmericaUnited States of America
      Flag of SpainSpain

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      OLON Group is a prominent worldwide firm specializing in the creation and manufacture of active pharmaceutical ingredients for CDMO and Generics. It serves as a dependable and preferred partner for the pharmaceutical, biotech, and specialty ingredients sectors. With a 2021 turnover of 580 million dollars, OLON provides 300 APIs for the Generic market. The company benefits from a workforce of 2,300 employees, including a highly skilled R&D team of over 300 individuals. This enables OLON to offer comprehensive integrated packages and services to facilitate the full development of APIs, leveraging extensive expertise in both Chemical and Biological processes, all within a full cGMP and regulatory framework. OLON holds approximately 160 active US DMFs and 79 granted CoS. OLON's headquarters is located in Rodano, near Milan, Italy, and it operates 11 manufacturing facilities - 8 in Italy, 1 in Spain, 1 in the USA, and 1 in India. These facilities are designed in accordance with the most stringent international standards. Additionally, OLON has 3 branch offices in Hamburg (Germany), Florham Park, NJ (USA), and Shanghai (China).

    • Small logo of Dishman Carbogen Amcis

      Dishman Carbogen Amcis

      Manufacturer
      Audited
      Non-Compliance Report

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia
      Flag of NetherlandsNetherlands
      Flag of SwitzerlandSwitzerland
      Flag of FranceFrance

      Regulatory compliance

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

      Company description

      For more than three decades, we have been providing support to the pharmaceutical and biopharmaceutical sectors in the development of medications. Our aim is to aid our clients in the creation and introduction of new drugs to the market, ultimately enhancing the well-being of patients globally. We are dedicated to assisting our partners in producing and manufacturing intricate and demanding compounds, highly active ingredients, and pioneering advancements in vitamin, healthcare, and industrial products with the goal of making the world a better place.

    • 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 Polepharma

      Polepharma

      Manufacturer

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of PolandPoland

      Regulatory compliance

      EDQM
      FDA
      GDUFA

      Company description

      Polepharma has been organizing and advancing the pharmaceutical industry in France, specializing in the biopharmaceutical sector for two decades. It has developed into the leading European hub for drug production, facilitating collaboration between excellence centers and industry stakeholders. Polepharma is committed to three collective principles, including the bold ambition to position France as the global leader in pharmaceutical development. On the other hand, Polpharma is a prominent CDMO and API producer based in Poland. With over 70 years of expertise, it stands as the largest API manufacturer in Poland, offering a comprehensive range of materials from clinical quantities to market supply. The company has fully integrated its operations, covering R&D to manufacturing, to provide cost-effective and timely solutions to its clients. Furthermore, Polpharma has made significant investments to enhance its API plant in Starogard Gdanski, incorporating HPAPI and cryogenic technologies, along with a pilot plant and R&D capabilities.

    • Small logo of Mac-Chem Products

      Mac-Chem Products

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      EU WC
      WHO GMP
      KDMF
      FDA
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Mac-Chem has a National and Global footprint with a wide presence across the globe. Mac-Chem has carved a niche for itself in the exceedingly competitive and quality conscious sphere of Active Pharmaceutical Ingredients (API) manufacturing with US-FDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP and ISO certified facilities

    • Small logo of ScinoPharm

      ScinoPharm

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of TaiwanTaiwan

      Sites

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

      Regulatory compliance

      EDQM
      KDMF
      JDMF
      GDUFA
      FDA
      NDC API
      USDMF
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Products and Services ScinoPharm delivers high-value solutions to its customers with speed and flexibility through a full range of services from API development to commercialization, in addition to cGMP manufacture of materials for clinical trials. Our success is built on the growing partnerships with customers around the world in supply of generic APIs, custom process research services and custom manufacturing services.

    • Small logo of Archimica

      Archimica

      Manufacturer
      Audited

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly

      Regulatory compliance

      FDA
      JDMF
      KDMF
      GDUFA
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Our proprietary products (APIs) cater to the general pharmaceutical sector. We consistently deliver high-quality products and services, utilizing some of the most challenging chemical technologies in the world responsibly and continuously

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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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