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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Fortune 22 to the U.S. FDA. Original Data : FDA Website

    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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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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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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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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    01 13-DEOXY-3-[18F]FLUOROTHYMIDINE ([18F]FLT)

    02 1FLUOROMISONIDAZOLE F 18 INJECTION

    03 1FLUOROMISONIDAZOLE F18 INJECTION([18F]FMISO)

    04 1GALLIUM GA-68 CHLORIDE SOLUTION

    05 1SODIUM ACETATE C-11 INJECTION

    06 1SODIUM FLUORIDE F18 INJECTION

    07 1TAZAROTENE 1.5 MG AND 4.5 MG CAPSULES

    08 1TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER (I) TETRAFLUOROBORATE DRUG SUBSTANCE

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    01

    3-deoxy-3-[18f]fluorothymidine ([18f...

    U.S.A
    Discovery on Target
    Not Confirmed
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    02

    Fluoromisonidazole F 18 Injection

    U.S.A
    Discovery on Target
    Not Confirmed
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    03

    Fluoromisonidazole F18 Injection([18...

    U.S.A
    Discovery on Target
    Not Confirmed
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    04

    Sodium Acetate C-11 Injection

    U.S.A
    Discovery on Target
    Not Confirmed
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    05

    Sodium Fluoride F18 Injection

    U.S.A
    Discovery on Target
    Not Confirmed
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    06

    Tazarotene 1.5 Mg And 4.5 Mg Capsule...

    U.S.A
    Discovery on Target
    Not Confirmed
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    07

    Tetrakis (2-methoxyisobutylisonitril...

    U.S.A
    Discovery on Target
    Not Confirmed
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    08

    Gallium Ga-68 Chloride Solution

    U.S.A
    Discovery on Target
    Not Confirmed
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    Gallium Ga-68 Chloride Solution

    U.S.A
    arrow
    Discovery on Target
    Not Confirmed
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    Cardinal Health

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38571

    Submission : 2024-04-18

    Status : Active

    Type : II

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