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

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    Brigatinib

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    01 Ajinomoto OmniChem nv (1)

    02 Ampac Fine Chemicals (1)

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    01 Takeda Pharmaceutical Korea Co., Ltd. (2)

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    01 Brigatinib (2)

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    01 Japan (1)

    02 U.S.A (1)

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    Ajinomoto Company

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    Brigatinib

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    URL Supplier Web Content
    Takeda Pharmaceutical Korea Co., Ltd.
    2020-04-21
    Wed108-11-ND
    Ajinomoto OmniChem nv
    Belgium
    Cooppallaan 91 Wetteren, ...
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    AMPAC Fine Chemicals

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    Brigatinib

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    Takeda Pharmaceutical Korea Co., Ltd.
    2020-04-21
    Wed108-10-ND
    Ampac Fine Chemicals
    U.S.A
    Highway 50 & Hazel Avenue...
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    Looking for 1197953-54-0 / Brigatinib API manufacturers, exporters & distributors?

    Brigatinib manufacturers, exporters & distributors 1

    25

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

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

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

    API | Excipient name

    Brigatinib

    Synonyms

    1197953-54-0, Alunbrig, Ap-26113, Brigatinib [usan], Brigatinib (ap-26113), Hyw8db273j

    Cas Number

    1197953-54-0

    Unique Ingredient Identifier (UNII)

    HYW8DB273J

    About Brigatinib

    Brigatinib is an orally available inhibitor of receptor tyrosine kinases anaplastic lymphoma kinase (ALK) and the epidermal growth factor receptor (EGFR) with potential antineoplastic activity. Brigatinib binds to and inhibits ALK kinase and ALK fusion proteins as well as EGFR and mutant forms. This leads to the inhibition of ALK kinase and EGFR kinase, disrupts their signaling pathways and eventually inhibits tumor cell growth in susceptible tumor cells. In addition, AP26113 appears to overcome mutation-based resistance. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development; ALK dysregulation and gene rearrangements are associated with a series of tumors. EGFR is overexpressed in a variety of cancer cell types.

    Brigatinib Manufacturers

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

    Brigatinib Suppliers

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

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

    Brigatinib KDMF

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

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

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

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

    Brigatinib Manufacturers | Traders | Suppliers

    Brigatinib Manufacturers, Traders, Suppliers 1
    54

    We have 2 companies offering Brigatinib

    Get in contact with the supplier of your choice:

    1. Ajinomoto Company
    2. AMPAC Fine Chemicals
    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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