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

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    Fedratinib

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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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 Teva Pharmaceutical Industries (1)

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    01 FEDRATINIB HYDROCHLORIDE (1)

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    TEVA PHARMACEUTICAL INDUSTRIES LTD

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    FEDRATINIB HYDROCHLORIDE

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    37888
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    2023-03-22
    Complete
    2023-05-09
    2023-01-31
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    Looking for 936091-26-8 / Fedratinib API manufacturers, exporters & distributors?

    Fedratinib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Fedratinib

    Synonyms

    936091-26-8, Tg-101348, Tg101348, Sar302503, Sar-302503, N-(tert-butyl)-3-((5-methyl-2-((4-(2-(pyrrolidin-1-yl)ethoxy)phenyl)amino)pyrimidin-4-yl)amino)benzenesulfonamide

    Cas Number

    936091-26-8

    Unique Ingredient Identifier (UNII)

    6L1XP550I6

    About Fedratinib

    Fedratinib is an orally bioavailable, small-molecule, ATP-competitive inhibitor of Janus-associated kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3; CD135; STK1; FLK2), with potential antineoplastic activity. Upon oral administration, fedratinib competes with wild-type JAK2 as well as mutated forms for ATP binding, which may result in inhibition of JAK2 activation, inhibition of the JAK-STAT signaling pathway, inhibition of tumor cell proliferation and induction of tumor cell apoptosis. JAK2 is the most commonly mutated gene in bcr-abl-negative myeloproliferative disorders (MPDs). In addition, fedratinib targets, binds to and inhibits the activity of FLT3. This inhibits uncontrolled FLT3 signaling and results in the inhibition of proliferation in tumor cells overexpressing FLT3. FLT3, a class III receptor tyrosine kinase (RTK), is overexpressed or mutated in most B-lineage neoplasms and in acute myeloid leukemias and plays a key role in tumor cell proliferation.

    Fedratinib Manufacturers

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

    Fedratinib Suppliers

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

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

    Fedratinib USDMF

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

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

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

    Fedratinib Manufacturers | Traders | Suppliers

    Fedratinib Manufacturers, Traders, Suppliers 1
    62

    We have 1 companies offering Fedratinib

    Get in contact with the supplier of your choice:

    1. Teva Pharmaceutical Industries
    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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