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    List of Drug Master Files (KDMF) for Upadacitinib Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Upadacitinib

    APIs // Active Pharmaceutical Ingredients

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    PharmaCompass

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 AbbVie Ireland NL BV (1)

    02 CURIA SPAIN SAU (1)

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    01 AbbVie Korea Co., Ltd. (1)

    02 Samo Pharmaceutical Co., Ltd. (1)

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    01 Upadacitinib (1)

    02 Upadacitinib hemihydrate (1)

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    01 U.S.A (2)

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    AbbVie Inc

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    • EDQM
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    Upadacitinib hemihydrate

    PDF Supplier PDF
    URL Supplier Web Content
    AbbVie Korea Co., Ltd.
    2020-06-04
    Wed325-12-ND
    AbbVie Ireland NL BV
    Ireland
    Manorhamilton Road Sligo,...
    Abbvie Company Banner

    Iran Expo

    Not Confirmed

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    Curia

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    • WHO-GMP
    • Audit Compliance
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    Upadacitinib

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    URL Supplier Web Content
    Samo Pharmaceutical Co., Ltd.
    2023-11-30
    Wed207-61-ND
    CURIA SPAIN SAU
    Spain
    Parque Tecnológico de Bo...
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    Looking for 1310726-60-3 / Upadacitinib API manufacturers, exporters & distributors?

    Upadacitinib manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Upadacitinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Upadacitinib manufacturer or Upadacitinib supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Upadacitinib manufacturer or Upadacitinib supplier.

    PharmaCompass also assists you with knowing the Upadacitinib API Price utilized in the formulation of products. Upadacitinib API Price is not always fixed or binding as the Upadacitinib Price is obtained through a variety of data sources. The Upadacitinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Upadacitinib

    Synonyms

    1310726-60-3, Abt-494, Rinvoq, Upadacitinib anhydrous, 4ra0kn46e0, (3s,4r)-3-ethyl-4-(1,5,7,10-tetrazatricyclo[7.3.0.02,6]dodeca-2(6),3,7,9,11-pentaen-12-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide

    Cas Number

    1310726-60-3

    Unique Ingredient Identifier (UNII)

    4RA0KN46E0

    About Upadacitinib

    Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor and a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis to slow down disease progression. Rheumatoid arthritis is a chronic autoimmune inflammatory disease affecting the peripheral joints. It is characterized by synovial inflammation and hyperplasia, autoantibody production, cartilage damage and bone destruction, leading to co-morbidities. Despite a variety of therapeutic agents available for treatment, up to 40% of the patients do not respond to current therapies, including biological therapies. The etiology of the disease is mostly unknown; however, the role of JAK as a driver of immune-mediated conditions was discovered, leading to the use of JAK as therapeutic targets for rheumatoid arthritis. To reduce dose-related toxicity (as seen with some pan-JAK inhibitors) without significantly affecting efficacy, more selective JAK1 inhibitors, upadacitinib and [filgotinib], were developed. The FDA approved Upadacitinib in August 2019 for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, it was additionally approved by the European Commission for the same indication in patients with inadequate response or intolerance to one or more DMARDs and can be used as monotherapy or in combination with methotrexate. Upadacitinib is marketed under the brand name RINVOQ for oral administration. It is currently being investigated in several clinical trials assessing its therapeutic effectiveness in other inflammatory diseases, such as psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and atopic dermatitis.

    Upadacitinib Manufacturers

    A Upadacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Upadacitinib, including repackagers and relabelers. The FDA regulates Upadacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Upadacitinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Upadacitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Upadacitinib Suppliers

    A Upadacitinib supplier is an individual or a company that provides Upadacitinib active pharmaceutical ingredient (API) or Upadacitinib finished formulations upon request. The Upadacitinib suppliers may include Upadacitinib API manufacturers, exporters, distributors and traders.

    click here to find a list of Upadacitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Upadacitinib KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Upadacitinib Drug Master File in Korea (Upadacitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Upadacitinib. The MFDS reviews the Upadacitinib KDMF as part of the drug registration process and uses the information provided in the Upadacitinib KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Upadacitinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Upadacitinib API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Upadacitinib suppliers with KDMF on PharmaCompass.

    Upadacitinib Manufacturers | Traders | Suppliers

    Upadacitinib Manufacturers, Traders, Suppliers 1
    99

    We have 2 companies offering Upadacitinib

    Get in contact with the supplier of your choice:

    1. AbbVie Inc
    2. Curia
    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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