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

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    ALUNBRIG

    APIs // Active Pharmaceutical Ingredients

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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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    URL Supplier Web Content
    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.

    ALUNBRIG Manufacturers

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

    ALUNBRIG Suppliers

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

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

    ALUNBRIG KDMF

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

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

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

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

    ALUNBRIG Manufacturers | Traders | Suppliers

    ALUNBRIG Manufacturers, Traders, Suppliers 1
    64

    We have 2 companies offering ALUNBRIG

    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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