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

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    Filgotinib

    APIs // Active Pharmaceutical Ingredients

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    01 Cambrex Charles City, Inc (1)

    02 Gilead Alberta ULC (1)

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    01 Korea Eisai Co., Ltd. (2)

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    01 Filgotinib maleate (2)

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    01 U.S.A (2)

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    Cambrex Corporation

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    Filgotinib maleate

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    Korea Eisai Co., Ltd.
    2022-04-01
    Wed205-26-ND
    Cambrex Charles City, Inc
    U.S.A
    1205 11th Street - Charle...
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    Gilead Sciences

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    Filgotinib maleate

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    Korea Eisai Co., Ltd.
    2022-04-01
    Wed205-27-ND
    Gilead Alberta ULC
    Canada
    1021 Hayter Road, Edmonto...
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    Looking for 1206161-97-8 / Filgotinib API manufacturers, exporters & distributors?

    Filgotinib manufacturers, exporters & distributors 1

    23

    PharmaCompass offers a list of Filgotinib 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 Filgotinib manufacturer or Filgotinib supplier for your needs.

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

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

    API | Excipient name

    Filgotinib

    Synonyms

    1206101-20-3, Glpg0634, 1206161-97-8, Glpg-0634, N-(5-(4-((1,1-dioxidothiomorpholino)methyl)phenyl)-[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide, Filgotinib (glpg0634)

    Cas Number

    1206161-97-8

    Unique Ingredient Identifier (UNII)

    3XVL385Q0M

    About Filgotinib

    Filgotinib is an orally bioavailable inhibitor of the tyrosine kinase Janus kinase 1 (JAK1), with potential anti-inflammatory and immunomodulating activities. Upon oral administration, filgotinib specifically targets, binds to, and inhibits the phosphorylation of JAK1, which interferes with JAK/STAT (signal transducer and activator of transcription)-dependent signaling. As JAK1 mediates signaling of many pro-inflammatory cytokines, JAK1 inhibition prevents cytokine signaling and activity in many inflammatory and immune-mediated processes and leads to a decrease in inflammation and activation of certain immune cells. JAK1 plays a key role in the signaling and activity of many cytokines and growth factors and is often dysregulated in a variety of autoimmune and inflammatory diseases, as well as some malignancies.

    Filgotinib Manufacturers

    A Filgotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Filgotinib, including repackagers and relabelers. The FDA regulates Filgotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Filgotinib 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 Filgotinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Filgotinib Suppliers

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

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

    Filgotinib KDMF

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

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

    After submitting a Filgotinib 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 Filgotinib API can apply through the Korea Drug Master File (KDMF).

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

    Filgotinib Manufacturers | Traders | Suppliers

    Filgotinib Manufacturers, Traders, Suppliers 1
    19

    We have 2 companies offering Filgotinib

    Get in contact with the supplier of your choice:

    1. Cambrex Corporation
    2. Gilead Sciences
    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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