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    Pirtobrutinib

    ACTIVE PHARMA INGREDIENTS

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    Bioprocess International Europe
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    Msn Laboratories Private Ltd

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 43823

    Submission : 2026-03-24

    Status : Active

    Type : II

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    Dr Reddys Laboratories Ltd

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    Dr Reddys Laboratories Ltd

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    DMF Review : N/A

    Rev. Date :

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    DMF Number : 43730

    Submission : 2026-03-31

    Status : Active

    Type : II

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    Looking for 2101700-15-4 / Pirtobrutinib API manufacturers, exporters & distributors?

    Pirtobrutinib manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Pirtobrutinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pirtobrutinib manufacturer or Pirtobrutinib supplier for your needs.

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

    API | Excipient name

    Pirtobrutinib

    Synonyms

    Loxo-305, 2101700-15-4, Pirtobrutinib [usan], Jna39i7zvb, (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, Ly3527727

    Cas Number

    2101700-15-4

    Unique Ingredient Identifier (UNII)

    JNA39I7ZVB

    About Pirtobrutinib

    Pirtobrutinib is an orally available, selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor with potential antineoplastic activity. Upon oral administration, pirtobrutinib selectively and reversibly binds to BTK. This prevents both the activation of the B-cell antigen receptor (BCR) signaling pathway and BTK-mediated activation of downstream survival pathways, thereby inhibiting the growth of malignant B-cells that overexpress BTK. Reversible binding of LOXO-305 may preserve antitumor activity in the presence of certain acquired resistance mutations, including C481 mutated BTK, and limit toxicity associated with inhibition of other non-BTK kinases. BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed or mutated in B-cell malignancies; it plays an important role in the development, activation, signaling, proliferation and survival of B-lymphocytes.

    Pirtobrutinib Manufacturers

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

    Pirtobrutinib Suppliers

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

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

    Pirtobrutinib USDMF

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

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

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

    Pirtobrutinib Manufacturers | Traders | Suppliers

    Pirtobrutinib Manufacturers, Traders, Suppliers 1
    67

    We have 1 companies offering Pirtobrutinib

    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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