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

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    Neratinib Maleate

    APIs // Active Pharmaceutical Ingredients

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    01 ESTEVE QUIMICA, SA@Esteve Quimica, SA (1)

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    Esteve Quimica

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    Neratinib maleate

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    Big Think Co., Ltd.
    2021-10-19
    Number 954-1-ND
    ESTEVE QUIMICA, SA@Esteve...
    Spain
    C/Ter, 94. Polígon Indus...
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    Looking for 915942-22-2 / Neratinib API manufacturers, exporters & distributors?

    Neratinib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Neratinib

    Synonyms

    915942-22-2, Neratinib maleate [mi], Neratinib (maleate), 9rm7xy23zs, 915942-22-2 (maleate), (e)-n-(4-((3-chloro-4-(pyridin-2-ylmethoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide maleate

    Cas Number

    915942-22-2

    Unique Ingredient Identifier (UNII)

    9RM7XY23ZS

    About Neratinib

    Neratinib Maleate is the maleate salt form of neratinib, an orally available, quinazoline-based, irreversible inhibitor of both the receptor tyrosine kinases (RTKs) human epidermal growth factor receptor 2 (HER2; ERBB2) and human epidermal growth factor receptor (EGFR), with potential antineoplastic activity. Upon administration, neratinib targets and covalently binds to the cysteine residue in the ATP-binding pockets of both HER2 and EGFR. This inhibits their activity and results in the inhibition of downstream signal transduction events, induces cell cycle arrest, apoptosis and ultimately decreases cellular proliferation in HER2- and EGFR-expressing tumor cells. EGFR and HER2, RTKs that are mutated or overactivated in many tumor cell types, play key roles in tumor cell proliferation and tumor vascularization.

    Neratinib Maleate Manufacturers

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

    Neratinib Maleate Suppliers

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

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

    Neratinib Maleate KDMF

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

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

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

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

    Neratinib Maleate Manufacturers | Traders | Suppliers

    Neratinib Maleate Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Neratinib Maleate

    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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