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    • Pliva Hrvatska

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of CroatiaCroatia

      Sites

      Flag of CroatiaCroatia
      Flag of United States of AmericaUnited States of America
      Flag of PolandPoland
      Flag of IndiaIndia
      Flag of Czech RepublicCzech Republic

      Regulatory compliance

      FDA
      JDMF
      KDMF
      GDUFA
      NDC API
      CEP COS
      USDMF

      Audit standards

      GMP (APIs)
      GMP (Finished Dosage)

      Company description

      We are committed to providing innovative and quality medicines to the nearly 200 million people we serve around the world every day; we make contact with patients, families and communities for better health and better days.

    • Small logo of Sanofi

      Sanofi

      Manufacturer
      Audited
      Audit report available
      Warning letter

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
      Flag of GermanyGermany
      Flag of SingaporeSingapore
      Flag of TürkiyeTürkiye
      Flag of BrazilBrazil
      Flag of HungaryHungary
      Flag of United States of AmericaUnited States of America

      Regulatory compliance

      EDQM
      WHO GMP
      KDMF
      JDMF
      GDP
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (Finished Dosage)
      GMP (APIs)
      GDP (Distribution)

      Company description

      Sanofi is a global healthcare leader committed to improving lives around the world. With a strong focus on research and development, Sanofi strives to transform scientific innovation into healthcare solutions that address unmet medical needs. The company's extensive portfolio spans prescription medicines, vaccines, consumer healthcare products, and biopharmaceuticals, covering a wide range of therapeutic areas, including diabetes, cardiovascular disease, oncology, immunology, rare diseases, and vaccines.

    • Small logo of Midas Pharma

      Midas Pharma

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of GermanyGermany
      Flag of FranceFrance

      Regulatory compliance

      GDP
      USDMF
      CEP COS

      Audit standards

      GDP (Distribution)

      Company description

      Midas Pharma, a medium-sized pharmaceutical company, offers a wide range of products and services throughout the entire industry value chain. With nearly 25 years of experience, we serve as a facilitator for collaboration and have contributed to unleashing undiscovered potential for our clients and partners

    • Small logo of Kinsy

      Kinsy

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of SpainSpain

      Sites

      Flag of SpainSpain

      Regulatory compliance

      KDMF
      EDQM
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      KINSY is an independent chemical company, located in Murcia (Spain), having broad expertise in development, scale-up and commercial production of fine chemicals, with a strong focus on development and manufacturing of key pharmaceutical intermediates and APIs under cGMP.

    • Temmler Pharma

      Manufacturer

      Headquarters

      Flag of GermanyGermany

      Sites

      Flag of GermanyGermany
      Flag of IrelandIreland

      Regulatory compliance

      FDA
      USDMF
    • Credo Life Sciences

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Company description

      Credo Life stands as one of the foremost producers and suppliers of Specialized Pellet and Taste Mask Granules / DC Granules situated in Hyderabad, India. The organization's principles are anchored in trustworthiness, dedication, excellence, and punctual delivery.

    • Small logo of Zhejiang Jiuzhou Pharmaceutical

      Zhejiang Jiuzhou 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
      FDA
      JDMF
      KDMF
      GDUFA
      USDMF
      CEP COS
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (Abbreviated Name: Jiuzhou Pharma, Stock Code: 603456.SH), founded in 1998 and headquartered in Taizhou, Zhejiang, is a leading contract development and manufacturing organization (CDMO) that successfully evolved from a generic API manufacturer. We provide pharmaceutical companies worldwide with one-stop innovative drug development and manufacturing solutions and services throughout the development lifecycle of an innovative drug—from preclinical chemical manufacturing and control (CMC) through phase I/II/III clinical trials and new drug applications (NDA) to commercialization. As a leader in green pharmaceutical manufacturing, we have developed frontier environmentally-friendly pharmaceutical technologies with independent intellectual property rights. We are committed to providing our customers with industry-leading technical solutions that enhance R&D efficiency and success while reducing costs. Serve life, guard health. We are committed to becoming a distinguished global life science company that provides innovative drug solutions to help our partners accelerate the time to market of innovative drugs and benefit patients worldwide.

    • Enaltec Labs

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (Subcontracted Laboratory)

      Company description

      Enaltec was established in 2006 by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology-driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world.

    • Titan Laboratories

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      WHO GMP
      EU WC
      KDMF
      EDQM

      Audit standards

      GMP (Finished Dosage)

      Company description

      Since our inception in 2006, Titan Laboratories has focused on formulating new-age solutions in diversified spectrums of Pellets, Granules, Tablets and Capsule manufacturing. With the expertise of such widespread specialties, we at Titan Laboratories take great pride in our proficiency in providing Quality Analytical Services that focus on the formulation & packaging of both solid and semi-solid finished products. Backed by our holistic approach towards catering to multifarious integrated services, we aim to meet the concept-to-commercialization needs of our customers while providing quality pellets, granules or finish formulations.

    • Small logo of Euroapi

      Euroapi

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of FranceFrance

      Sites

      Flag of FranceFrance
      Flag of HungaryHungary
      Flag of GermanyGermany
      Flag of United KingdomUnited Kingdom
      Flag of ItalyItaly
      Flag of SlovakiaSlovakia

      Regulatory compliance

      EDQM
      GDUFA
      KDMF
      JDMF
      FDA
      CEP COS
      USDMF
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Euroapi focuses on revolutionizing active component solutions to sustainably fulfill the demands of clients and patients globally. As a prominent figure in active pharmaceutical ingredients, we possess a comprehensive portfolio of around 200 products, encompassing a wide range of technologies, and are constantly developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO). Our 3,350 employees are driven by the commitment to improving access to essential therapies and promoting health

    • Small logo of Veranova

      Veranova

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of United States of AmericaUnited States of America

      Sites

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

      Regulatory compliance

      EDQM
      GDUFA
      GMP
      KDMF
      FDA
      JDMF
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      Veranova boasts over 50 years of expertise and is a frontrunner in the creation and fabrication of intricate and specialized APIs for the pharmaceutical and biotech sectors. It was previously a segment of Johnson Matthey, specializing in intricate and regulated chemical processes. The company delivers customized services throughout all phases of drug development and is split into Generics and Originators. It possesses a variety of development technologies and areas of expertise, along with a cooperative approach to API manufacturing and procedures.

    • Small logo of Solara Active Pharma Sciences

      Solara Active Pharma Sciences

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

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

      Audit standards

      GMP (APIs)

      Company description

      Solara is an API manufacturer focused on research and customer satisfaction, operating in over 75 countries. They specialize in producing APIs for niche therapeutic categories, including complex products like polymer-based APIs and injectable APIs. The company has a team of experienced scientists supported by 6 manufacturing facilities and 2 R&D centers. Additionally, Solara offers Contract Research and Manufacturing Services (CRAMS) from discovery to late phase commercial manufacturing. Solara Active Pharma Sciences, with roots in Strides Shasun Ltd. and Sequent Scientific Ltd., is committed to providing value-based products while prioritizing customer needs. The company has 140+ scientists working at 2 R&D centers and 4 API manufacturing facilities, all with global approvals and 2 dedicated R&D facilities.

    • Small logo of Egis Pharmaceuticals

      Egis Pharmaceuticals

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of HungaryHungary

      Sites

      Flag of HungaryHungary

      Regulatory compliance

      KDMF
      JDMF
      GDUFA
      FDA
      EDQM
      GDP
      CEP COS
      USDMF
      NDC API

      Audit standards

      GMP (APIs)

      Company description

      Egis Pharmaceuticals PLC is a prominent generic pharmaceutical firm engaged primarily in Central and Eastern Europe. The company's operations encompass all aspects of the pharmaceutical value chain from research and development to the manufacturing of APIs and final products, as well as sales and marketing in over 60 nations. Egis possesses extensive expertise in the advancement of value-added generic compounds, effective production processes, reliable analytical techniques for impurity determination, comprehensive understanding of organic chemical reactions, and robust IP support.

    • Small logo of Boehringer Ingelheim

      Boehringer Ingelheim

      Manufacturer

      Headquarters

      Flag of GermanyGermany

      Sites

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

      Regulatory compliance

      EDQM
      KDMF
      JDMF
      GDP
      CEP COS
      USDMF
      NDC API
    • 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 Summit Pharmaceuticals Europe

      Summit Pharmaceuticals Europe

      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of GermanyGermany

      Audit standards

      ISO 9001

      Company description

      Summit Pharmaceuticals Europe S.r.l. (SPE) forms part of Sumitomo Corporation, a Japanese trading and investment company. Operating in Europe, SPE focuses on serving the chemical-pharma industries. Our offerings encompass a wide range of services, intermediates, and APIs, extending to finished dosage forms. Leveraging our extensive network, we provide support for your business expansion into new markets. For additional details, visit www.summipharmaeurope.com and https://www.youtube.com/channel/UCbwT6cHHr4gVrAgwmaImfOQ

    • Small logo of Cosma

      Cosma

      Manufacturer
      Audited
      Audit report available

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly

      Regulatory compliance

      GDUFA
      JDMF
      KDMF
      FDA
      USDMF
      NDC API
      CEP COS

      Audit standards

      GMP (APIs)

      Company description

      COSMA S. P. A. (established in 1977) and AMSA S. P. A. (established in 1953) are a pair of chemical facilities widely recognized globally and particularly valued in the occidental world and in the nations that adhere to the Pharmaceutical Inspection Convention (PIC). They are part of the CFM Group, a privately-owned company engaged in the fields of chemistry and pharmaceuticals since 1949

    • Small logo of S.I.M.S.

      S.I.M.S.

      Manufacturer
      Audited

      Headquarters

      Flag of ItalyItaly

      Sites

      Flag of ItalyItaly

      Regulatory compliance

      FDA
      GDUFA

      Company description

      Società Italiana Medicinali Scandicci, known as S.I.M.S. srl, was established in Scandicci in 1937 by Mr Ugo Rangoni. During the 1950s and 1960s, it experienced growth in both production and personnel. In 1972, the first DMF (phenylbutazone) was presented to the FDA. The current API facility in Reggello has been operational since 1974 and has been regularly examined by the Agency ever since. Since the 1980s, the company has garnered increasing recognition in the field of custom-toll manufacturing through GMP status with major partners. The company has more than 20 APIs with registered DMF and, when applicable, the corresponding CEP.

    • Small logo of Zim Laboratories

      Zim Laboratories

      Manufacturer

      Headquarters

      Flag of IndiaIndia

      Sites

      Flag of IndiaIndia

      Regulatory compliance

      EDQM
      WHO GMP
      EU WC

      Company description

      Zim offers innovative solutions for administering medications, focusing on enhancing patient convenience and compliance. The company utilizes its own advanced technologies, such as modified release and taste masking, to create and produce distinct pharmaceutical products. Their range includes oral solid dosage formulations and pre-formulations (PFI), encompassing tablets, capsules, dry syrups, pellets, granules, and orally disintegrating strips (ODS). Additionally, they provide services for site transfer/variation for sustained release tablets, oral disintegrating tablets, fast disintegrating capsules, and more.

    • Small logo of Aenova Group

      Aenova Group

      Manufacturer
      Audited

      Headquarters

      Flag of GermanyGermany

      Sites

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

      Regulatory compliance

      EDQM
      FDA
      GDUFA
      USDMF

      Company description

      The Aenova Group is a prominent global provider of contract manufacturing and development services for the pharmaceutical and healthcare sectors. Aenova offers comprehensive services in the development, production, and packaging of various pharmaceutical and food supplement dosage forms, catering to both human and animal health needs. With a workforce of approximately 4,200 individuals spread across 16 locations worldwide, Aenova is dedicated to enhancing its development and production portfolio in areas such as bioavailability of active pharmaceutical ingredients and specialized technologies for complex therapeutic systems.

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