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

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    01 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE) (1)

    02 ADAPALENE (1)

    03 BALSALAZIDE DISODIUM (1)

    04 BECLOMETASONE DIPROPIONATE MONOHYDRATE MICRONIZED (1)

    05 BECLOMETHASONE DIPROPIONATE (1)

    06 BETAMETHASONE DIPROPIONATE MICRONIZED (1)

    07 BETAMETHASONE VALERATE (1)

    08 BUDESONIDE (1)

    09 BUDESONIDE MICRONIZED STERILE (1)

    10 BUSULFAN (1)

    11 CANNABIDIOL (1)

    12 CEFUROXIME SODIUM STERILE USP (1)

    13 CELECOXIB USP (1)

    14 CLOBETASOL PROPIONATE (1)

    15 CLOCORTOLONE PIVALATE (MICRONIZED) (1)

    16 CYPROTERONE ACETATE (1)

    17 DELTA-1-CORTIENIC ACID (1)

    18 DESONIDE DRUG SUBSTANCE (1)

    19 DESOXIMETASONE (1)

    20 DEXAMETHASONE USP (1)

    21 DIFLUPREDNATE (MICRONIZED) (1)

    22 EPOXIDE DESOXYMETASONE (INTERMEDIATE) (1)

    23 ESMOLOL HYDROCHLORIDE (1)

    24 EXEMESTANE MICRONIZED USP (1)

    25 FLUDROCORTISONE ACETATE (1)

    26 FLUMETHASONE (1)

    27 FLUNISOLIDE ANHYDROUS USP (1)

    28 FLUNISOLIDE HEMIHYDRATE (MICRONIZED) (1)

    29 FLUOCINOLONE ACETONIDE (1)

    30 FLUOCINONIDE, MICRONIZED BP/USP (1)

    31 FLUOROMETHOLONE (1)

    32 FLURANDRENOLIDE (1)

    33 FLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED) (1)

    34 FORMOTEROL FUMARATE (1)

    35 FULVESTRANT (1)

    36 HALCINONIDE (1)

    37 HYDROCORTISONE HEMISUCCINATE (1)

    38 ICOSAPENT ETHYL (1)

    39 LOTEPREDNOL ETABONATE (1)

    40 LOTEPREDNOL ETABONATE STERILE MICRONIZED (1)

    41 MEDROXYPROGESTERONE ACETATE (1)

    42 MEGESTROL ACETATE (1)

    43 MELPHALAN HYDROCHLORIDE (1)

    44 METHYLPREDNISOLONE ACETATE STERILE (1)

    45 METHYLTESTOSTERONE (MICRONIZED) (1)

    46 MIVACURIUM CHLORIDE (1)

    47 MOMETASONE FUROATE (1)

    48 MOMETASONE FUROATE (ALTERNATE PROCESS) (1)

    49 N-ACETYL-L-CYSTEINE (1)

    50 PACLITAXEL (1)

    51 PROPAFENONE HYDROCHLORIDE (1)

    52 SG-3249 (INTERMEDIATE DRUG LINKER) (1)

    53 STERILE PREDNISOLONE-21-ACETATE MICRONIZED (1)

    54 STERILIZED MEDROXYPROGESTERONE ACETATE USP (MICRONIZED) (1)

    55 TERIFLUNOMIDE (1)

    56 TIROFIBAN HYDROCHLORIDE MONOHYDRATE (1)

    57 TRIAMCINOLONE ACETONIDE (1)

    58 TRIAMCINOLONE ACETONIDE MICRONIZED STERILE (1)

    59 TRIAMCINOLONE DIACETATE (1)

    60 TRIAMCINOLONE HEXACETONIDE (1)

    61 ZOLPIDEM TARTRATE MODIFIED SYNTHESIS (1)

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    01 FARMABIOS SPA (49)

    02 FINORGA SAS (4)

    03 PHARMAZELL GMBH (5)

    04 PHARMAZELL INDIA PRIVATE LTD (1)

    05 SERIPHARM SAS (2)

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    01 France (6)

    02 Germany (5)

    03 India (1)

    04 Italy (49)

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    01 Active (61)

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    01 Complete (38)

    02 Blank (23)

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    5-AMINOSALICYLIC ACID (MESALAZINE/M...

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    PHARMAZELL GMBH
    Active
    8070
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    2014-12-16
    2014-11-28
    1989-05-09
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    ADAPALENE

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    FINORGA SAS
    Active
    8784
    N/A
    1990-10-12
    II
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    BALSALAZIDE DISODIUM

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    PHARMAZELL GMBH
    Active
    16425
    Complete
    2021-08-10
    2021-08-06
    2003-02-17
    II
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    BECLOMETASONE DIPROPIONATE MONOHYDR...

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    FARMABIOS SPA
    Active
    21972
    N/A
    2008-09-11
    II
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    BECLOMETHASONE DIPROPIONATE

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    FARMABIOS SPA
    Active
    12813
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    2019-04-25
    2019-04-22
    1998-01-05
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    BETAMETHASONE DIPROPIONATE MICRONIZ...

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    FARMABIOS SPA
    Active
    23118
    Complete
    2013-10-07
    2013-09-26
    2009-09-16
    II
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    BETAMETHASONE VALERATE

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    FARMABIOS SPA
    Active
    12749
    Complete
    2018-08-14
    2018-07-09
    1997-11-18
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    BUDESONIDE

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    FARMABIOS SPA
    Active
    18910
    Complete
    2013-05-16
    2013-05-03
    2005-10-26
    II
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    BUDESONIDE MICRONIZED STERILE

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    FARMABIOS SPA
    Active
    25615
    N/A
    2011-12-20
    II
    Axplora CB

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    BUSULFAN

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    FARMABIOS SPA
    Active
    25933
    Complete
    2013-08-08
    2012-12-17
    2012-03-27
    II
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