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

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    Osimertinib

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    01 Alembic Pharmaceuticals Limited (1)

    02 Hetero Drugs (1)

    03 MSN Laboratories (1)

    04 ScinoPharm Taiwan, Ltd (1)

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    01 OSIMERTINIB MESYLATE (4)

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    01 India (3)

    02 Taiwan (1)

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    01 Active (4)

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    ALEMBIC PHARMACEUTICALS LTD

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    OSIMERTINIB MESYLATE

    PDF Supplier PDF
    URL Supplier Web Content
    33409
    Active
    2018-12-31
    Complete
    2019-02-26
    2018-12-12
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    HETERO LABS LTD

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    OSIMERTINIB MESYLATE

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    35581
    Active
    2021-02-04
    N/A
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    MSN LABORATORIES PRIVATE LTD

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    OSIMERTINIB MESYLATE

    PDF Supplier PDF
    URL Supplier Web Content
    32143
    Active
    2017-12-29
    Complete
    2019-05-06
    2019-03-14
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    SCINOPHARM TAIWAN LTD

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    OSIMERTINIB MESYLATE

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    36546
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    2021-12-24
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    Looking for 1421373-66-1 / Osimertinib Mesylate API manufacturers, exporters & distributors?

    Osimertinib Mesylate manufacturers, exporters & distributors 1

    71

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

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

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

    API | Excipient name

    Osimertinib Mesylate

    Synonyms

    1421373-66-1, Azd-9291 mesylate, Azd9291 mesylate, Azd-9291 (mesylate), Mereletinib mesylate, Tagrisso

    Cas Number

    1421373-66-1

    Unique Ingredient Identifier (UNII)

    RDL94R2A16

    About Osimertinib Mesylate

    Osimertinib Mesylate is the mesylate salt form of osimertinib, a third-generation, orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor, with potential antineoplastic activity. Upon oral administration, osimertinib covalently binds to and inhibits the activity of numerous mutant forms of EGFR, including the secondarily-acquired resistance mutation T790M, L858R, and exon 19 deletions, thereby preventing EGFR-mediated signaling. This may both induce cell death and inhibit tumor growth in EGFR-overexpressing tumor cells. EGFR, a receptor tyrosine kinase mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization. As this agent is selective towards mutant forms of EGFR, its toxicity profile may be reduced when compared to non-selective EGFR inhibitors which also inhibit wild-type EGFR.

    Osimertinib Manufacturers

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

    Osimertinib Suppliers

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

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

    Osimertinib USDMF

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

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

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

    Osimertinib Manufacturers | Traders | Suppliers

    Osimertinib Manufacturers, Traders, Suppliers 1
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    We have 4 companies offering Osimertinib

    Get in contact with the supplier of your choice:

    1. Alembic Pharmaceuticals Limited
    2. Hetero Drugs
    3. MSN Laboratories
    4. ScinoPharm Taiwan, Ltd
    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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