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

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    01 ARIPIPRAZOLE (1)

    02 BENZNIDAZOLE (CODE 50954) (1)

    03 CARIPRAZINE HYDROCHLORIDE (1)

    04 DILTIAZEM HCL (1)

    05 ENALAPRIL MALEATE (2)

    06 FINGOLIMOD HYDROCHLORIDE (CODE 50996) (1)

    07 FLECAINIDE ACETATE PROCESS I (CODE 50064) (1)

    08 FLECAINIDE ACETATE PROCESS II (CODE 50856) (1)

    09 FLECAINIDE ACETATE PROCESS III (CODE 50970) (1)

    10 KETOROLAC TROMETHAMINE (1)

    11 LEFLUNOMIDE (1)

    12 LOSARTAN POTASSIUM (1)

    13 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EUGENIO GARZON, BUENOS AIRES. (1)

    14 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MORGUIONDO 2011, ARGENTINA (1)

    15 NICARDIPINE HYDROCHLORIDE (1)

    16 NITAZOXANIDE (1)

    17 OZANIMOD HYDROCHLORIDE (1)

    18 RANITIDINE HYDROCHLORIDE (1)

    19 RASAGILINE MESYLATE (CODE 50855) (1)

    20 TAMSULOSIN HYDROCHLORIDE (1)

    21 TERIFLUNOMIDE (1)

    22 ZOLEDRONIC ACID MONOHYDRATE (CODE 50787) (1)

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    01 MAPRIMED SA (23)

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    01 Argentina (23)

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    01 Active (10)

    02 Inactive (13)

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    01 Complete (8)

    02 Blank (15)

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    ARIPIPRAZOLE

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    MAPRIMED SA
    Inactive
    26921
    N/A
    2013-02-26
    II
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    BENZNIDAZOLE (CODE 50954)

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    MAPRIMED SA
    Inactive
    28359
    N/A
    2014-12-15
    II
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    CARIPRAZINE HYDROCHLORIDE

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    MAPRIMED SA
    Active
    33623
    Complete
    2019-08-14
    2019-03-15
    2019-03-22
    II
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    DILTIAZEM HCL

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    MAPRIMED SA
    Inactive
    7887
    N/A
    1989-02-07
    II
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    ENALAPRIL MALEATE

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    MAPRIMED SA
    Inactive
    20317
    N/A
    2007-03-02
    II
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    ENALAPRIL MALEATE

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    MAPRIMED SA
    Inactive
    11656
    N/A
    1995-09-18
    II
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    FINGOLIMOD HYDROCHLORIDE (CODE 5099...

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    MAPRIMED SA
    Active
    28322
    Complete
    2014-10-24
    2014-09-03
    2014-07-08
    II
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    FLECAINIDE ACETATE PROCESS I (CODE ...

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    MAPRIMED SA
    Active
    10688
    N/A
    1994-01-24
    II
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    FLECAINIDE ACETATE PROCESS II (CODE...

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    MAPRIMED SA
    Inactive
    24309
    N/A
    2010-10-13
    II
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    FLECAINIDE ACETATE PROCESS III (COD...

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    MAPRIMED SA
    Active
    28158
    Complete
    2014-09-22
    2014-04-28
    2014-05-15
    II
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