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    List of Drug Master Files (DMF) of Gilteritinib Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Gilteritinib

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    01 GILTERITINIB FUMARATE (1)

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    GILTERITINIB FUMARATE

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    36745
    Active
    2022-01-31
    Complete
    2022-06-23
    2022-06-10
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    Looking for 1254053-84-3 / Gilteritinib Fumarate API manufacturers, exporters & distributors?

    Gilteritinib Fumarate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Gilteritinib Fumarate

    Synonyms

    Gilteritinib hemifumarate, Asp-2215 hemifumarate, 1254053-84-3, Gilteritinib fumarate [usan], Asp2215 hemifumarate, 5rzz0z1gjt

    Cas Number

    1254053-84-3

    Unique Ingredient Identifier (UNII)

    5RZZ0Z1GJT

    About Gilteritinib Fumarate

    Gilteritinib Fumarate is the fumarate salt form of gilteritinib, an orally bioavailable inhibitor of the receptor tyrosine kinases (RTKs) FMS-like tyrosine kinase 3 (FLT3; STK1; FLK2), AXL (UFO; JTK11), anaplastic lymphoma kinase (ALK; CD246), and leukocyte receptor tyrosine kinase (LTK), with potential antineoplastic activity. Upon administration, gilteritinib binds to and inhibits both the wild-type and mutated forms of FLT3, AXL, ALK and LTK. This may result in an inhibition of FLT3-, AXL-, ALK-, and LTK-mediated signal transduction pathways and reduced proliferation in cancer cells that overexpress these RTKs. FLT3, AXL, ALK, and LTK, which are overexpressed or mutated in a variety of cancer cell types, play key roles in tumor cell growth and survival.

    Gilteritinib Manufacturers

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

    Gilteritinib Suppliers

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

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

    Gilteritinib USDMF

    A Gilteritinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Gilteritinib active pharmaceutical ingredient (API) in detail. Different forms of Gilteritinib DMFs exist exist since differing nations have different regulations, such as Gilteritinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Gilteritinib DMF submitted to regulatory agencies in the US is known as a USDMF. Gilteritinib USDMF includes data on Gilteritinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gilteritinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Gilteritinib suppliers with USDMF on PharmaCompass.

    Gilteritinib Manufacturers | Traders | Suppliers

    Gilteritinib Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Gilteritinib

    Get in contact with the supplier of your choice:

    1. MSN Laboratories
    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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