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    List of Korea Drug Master Files (KDMF) for Formoterol Fumarate Dihydrate Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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    Inke Formoterol Fumarate

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Chemistry

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    Also known as: Mls001401438, Chembl1895091, Hms2051p14, Hms2233m10, Ccg-101038, Nc00288
    Molecular Formula
    C23H30N2O9
    Molecular Weight
    478.5  g/mol
    InChI Key
    AXAGNMKWGBWLMO-GQMFVQBYSA-N
    Formoterol Fumarate
    1 2D Structure

    Formoterol Fumarate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-but-2-enedioic acid;N-[2-hydroxy-5-[(1S)-1-hydroxy-2-[[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide;hydrate
    2.1.2 InChI
    InChI=1S/C19H24N2O4.C4H4O4.H2O/c1-13(9-14-3-6-16(25-2)7-4-14)20-11-19(24)15-5-8-18(23)17(10-15)21-12-22;5-3(6)1-2-4(7)8;/h3-8,10,12-13,19-20,23-24H,9,11H2,1-2H3,(H,21,22);1-2H,(H,5,6)(H,7,8);1H2/b;2-1+;/t13-,19+;;/m0../s1
    2.1.3 InChI Key
    AXAGNMKWGBWLMO-GQMFVQBYSA-N
    2.1.4 Canonical SMILES
    CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O.C(=CC(=O)O)C(=O)O.O
    2.1.5 Isomeric SMILES
    C[C@@H](CC1=CC=C(C=C1)OC)NC[C@H](C2=CC(=C(C=C2)O)NC=O)O.C(=C/C(=O)O)\C(=O)O.O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Mls001401438

    2. Chembl1895091

    3. Hms2051p14

    4. Hms2233m10

    5. Ccg-101038

    6. Nc00288

    7. Smr000471620

    2.3 Create Date
    2007-12-08
    3 Chemical and Physical Properties
    Molecular Weight 478.5 g/mol
    Molecular Formula C23H30N2O9
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count10
    Exact Mass478.19513054 g/mol
    Monoisotopic Mass478.19513054 g/mol
    Topological Polar Surface Area166 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity507
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

    API Reference Price

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    21-Jan-2021
    28-Aug-2024
    KGS
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    DOSAGE - POWDER;INHALATION - 0.012MG/INH **Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20831

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    DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH

    USFDA APPLICATION NUMBER - 210595

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH

    USFDA APPLICATION NUMBER - 21929

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

    USFDA APPLICATION NUMBER - 21929

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH

    USFDA APPLICATION NUMBER - 22518

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    USFDA APPLICATION NUMBER - 22518

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

    USFDA APPLICATION NUMBER - 22518

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    Formoterol Fumarate Dihydrate Manufacturers | Traders | Suppliers

    Formoterol Fumarate Dihydrate Manufacturers, Traders, Suppliers 1
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    7. ST Pharma
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