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

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    Ivosidenib

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    01 Alembic Pharmaceuticals Limited (1)

    02 Teva Pharmaceutical Industries (1)

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    01 IVOSIDENIB (2)

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    02 Israel (1)

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    ALEMBIC PHARMACEUTICALS LTD

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    IVOSIDENIB

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    36786
    Active
    2022-02-17
    Complete
    2022-05-11
    2022-05-04
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    TEVA PHARMACEUTICAL INDUSTRIES LTD

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    IVOSIDENIB

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    36151
    Active
    2022-02-04
    Complete
    2022-03-02
    2021-12-14
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    Looking for 1448347-49-6 / Ivosidenib API manufacturers, exporters & distributors?

    Ivosidenib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Ivosidenib

    Synonyms

    1448347-49-6, Tibsovo, Ag-120, Ag120, Ivosidenib [inn], Ivosidenib [usan]

    Cas Number

    1448347-49-6

    Unique Ingredient Identifier (UNII)

    Q2PCN8MAM6

    About Ivosidenib

    Ivosidenib is an orally available inhibitor of isocitrate dehydrogenase type 1 (IDH1), with potential antineoplastic activity. Upon administration, AG-120 specifically inhibits a mutated form of IDH1 in the cytoplasm, which inhibits the formation of the oncometabolite, 2-hydroxyglutarate (2HG). This may lead to both an induction of cellular differentiation and an inhibition of cellular proliferation in IDH1-expressing tumor cells. IDH1, an enzyme in the citric acid cycle, is mutated in a variety of cancers; it initiates and drives cancer growth by both blocking cell differentiation and catalyzing the formation of 2HG.

    Ivosidenib Manufacturers

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

    Ivosidenib Suppliers

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

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

    Ivosidenib USDMF

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

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

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

    Ivosidenib Manufacturers | Traders | Suppliers

    Ivosidenib Manufacturers, Traders, Suppliers 1
    82

    We have 2 companies offering Ivosidenib

    Get in contact with the supplier of your choice:

    1. Alembic Pharmaceuticals Limited
    2. 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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