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

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    Tucatinib

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

    GLOBAL SALES INFORMATION

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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 ESTEVE QUIMICA, S.A. (1)

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    01 MSD Korea Co., Ltd. (1)

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    01 Tucatinib (1)

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    01 Spain (1)

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    Esteve Quimica

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    Tucatinib

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    MSD Korea Co., Ltd.
    2023-12-14
    Wed90-30-ND
    ESTEVE QUIMICA, S.A.
    Spain
    C/Ter, 94. Polígon Indus...
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    Looking for 937263-43-9 / Tucatinib API manufacturers, exporters & distributors?

    Tucatinib manufacturers, exporters & distributors 1

    70

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

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

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

    API | Excipient name

    Tucatinib

    Synonyms

    Irbinitinib, 937263-43-9, Ont-380, Tukysa, 6-diamine, N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)-n4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine

    Cas Number

    937263-43-9

    Unique Ingredient Identifier (UNII)

    234248D0HH

    About Tucatinib

    Tucatinib is an orally bioavailable inhibitor of the human epidermal growth factor receptor tyrosine kinase ErbB-2 (also called HER2) with potential antineoplastic activity. Tucatinib selectively binds to and inhibits the phosphorylation of ErbB-2, which may prevent the activation of ErbB-2 signal transduction pathways, resulting in growth inhibition and death of ErbB-2-expressing tumor cells. ErbB-2 is overexpressed in a variety of cancers and plays an important role in cellular proliferation and differentiation.

    Tucatinib Manufacturers

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

    Tucatinib Suppliers

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

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

    Tucatinib KDMF

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

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

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

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

    Tucatinib Manufacturers | Traders | Suppliers

    Tucatinib Manufacturers, Traders, Suppliers 1
    95

    We have 1 companies offering Tucatinib

    Get in contact with the supplier of your choice:

    1. Esteve Quimica
    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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