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

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    Acalabrutinib

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    01 Dottikon Exclusive Synthesis AG (2)

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    01 AstraZeneca Korea Co., Ltd. (2)

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    01 Acalabrutinib (1)

    02 Acalabrutinib maleate monohydrate (1)

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    01 Switzerland (2)

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    DOTTIKON EXCLUSIVE SYNTHESIS AG

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    Acalabrutinib

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    AstraZeneca Korea Co., Ltd.
    2021-02-05
    Wed248-15-ND
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17, 5605 ...
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    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Contact Supplier
    • FDA
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
    Post an Enquiry Post an Enquiry
    Flag Switzerland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Acalabrutinib maleate monohydrate

    PDF Supplier PDF
    URL Supplier Web Content
    AstraZeneca Korea Co., Ltd.
    2023-02-25
    Wed248-19-ND
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17, 5605 ...
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    Looking for 1420477-60-6 / Acalabrutinib API manufacturers, exporters & distributors?

    Acalabrutinib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Acalabrutinib

    Synonyms

    1420477-60-6, Acp-196, Calquence, Acalabrutinib (acp-196), Acalabrutinib [inn], I42748elqw

    Cas Number

    1420477-60-6

    Unique Ingredient Identifier (UNII)

    I42748ELQW

    About Acalabrutinib

    Acalabrutinib is an orally available inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, acalabrutinib 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. This leads to an 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.

    Acalabrutinib Manufacturers

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

    Acalabrutinib Suppliers

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

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

    Acalabrutinib KDMF

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

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

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

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

    Acalabrutinib Manufacturers | Traders | Suppliers

    Acalabrutinib Manufacturers, Traders, Suppliers 1
    34

    We have 1 companies offering Acalabrutinib

    Get in contact with the supplier of your choice:

    1. DOTTIKON EXCLUSIVE SYNTHESIS AG
    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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