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

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    Zanubrutinib

    APIs // Active Pharmaceutical Ingredients

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    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 MSN Laboratories (1)

    02 Olon S.p.A (1)

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    01 ZANUBRUTINIB (2)

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    01 India (1)

    02 Italy (1)

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    MSN LABORATORIES PRIVATE LTD

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    ZANUBRUTINIB

    PDF Supplier PDF
    URL Supplier Web Content
    38215
    Active
    2023-03-31
    Complete
    2023-08-08
    2023-05-30
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    OLON SPA

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    ZANUBRUTINIB

    PDF Supplier PDF
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    38350
    Active
    2023-05-12
    Complete
    2023-06-27
    2023-05-10
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    Looking for 1651179-04-2 / Zanubrutinib API manufacturers, exporters & distributors?

    Zanubrutinib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Zanubrutinib

    Synonyms

    1691249-45-2, Brukinsa, Bgb-3111, Zanubrutinib [inn], Zanubrutinib [usan], Ag9mhg098z

    Cas Number

    1651179-04-2

    Unique Ingredient Identifier (UNII)

    AG9MHG098Z

    About Zanubrutinib

    Zanubrutinib is an inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, zanubrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways, which leads to the inhibition of the growth of malignant B-cells that overexpress BTK. BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B-lymphocyte development, activation, signaling, proliferation and survival.

    Zanubrutinib Manufacturers

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

    Zanubrutinib Suppliers

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

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

    Zanubrutinib USDMF

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

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

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

    Zanubrutinib Manufacturers | Traders | Suppliers

    Zanubrutinib Manufacturers, Traders, Suppliers 1
    58

    We have 2 companies offering Zanubrutinib

    Get in contact with the supplier of your choice:

    1. MSN Laboratories
    2. Olon S.p.A
    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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