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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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    AXPLORA

    EVENTS

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    PRESENTATION(s)

    VIDEO(s)

    DIGITAL CONTENT

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Acetylcysteine

    • Balsalazide Disodium

    • Beclomethasone Dipropionate

    • Carbocisteine

    • Carbocysteine Lysine

    • Lysine

    • Lysine Acetate

    • Lysine Hydrochloride

    • Mesalazine

    • Methylene Blue

    • Olaparib

    • Propafenone Hydrochloride

    • Triamcinolone

    • Triamcinolone Acetonide

    • Triamcinolone Diacetate

    • Triamcinolone Hexacetonide

    • Ursodeoxycholic Acid

    • Zavegepant HCl

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Complex API Development Services

    • CDMO for Small Molecule APIs

    • API Custom Synthesis

    • Hazardous Chemistry

    • Flow Chemistry

    • Industrial Chromatography

    • Contract Development & Manufacturing for ADCs

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

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    5-AMINOSALICYLIC ACID (MESALAZINE/M...

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    PHARMAZELL GMBH
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    8070
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    2014-12-16
    2014-11-28
    1989-05-09
    II
    Axplora CB

    ChemOutsourcing

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    ADAPALENE

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    FINORGA SAS
    Active
    8784
    N/A
    1990-10-12
    II
    Axplora CB

    ChemOutsourcing

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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
    Axplora CB

    ChemOutsourcing

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    BECLOMETASONE DIPROPIONATE MONOHYDR...

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    FARMABIOS SPA
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    21972
    N/A
    2008-09-11
    II
    Axplora CB

    ChemOutsourcing

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    BECLOMETHASONE DIPROPIONATE

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    FARMABIOS SPA
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    12813
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    2019-04-25
    2019-04-22
    1998-01-05
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    Axplora CB

    ChemOutsourcing

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    BETAMETHASONE DIPROPIONATE MICRONIZ...

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    FARMABIOS SPA
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    23118
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    2013-10-07
    2013-09-26
    2009-09-16
    II
    Axplora CB

    ChemOutsourcing

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    BETAMETHASONE VALERATE

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

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    BUDESONIDE

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    18910
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    2013-05-03
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    ChemOutsourcing

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    BUDESONIDE MICRONIZED STERILE

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    FARMABIOS SPA
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    25615
    N/A
    2011-12-20
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    ChemOutsourcing

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    BUSULFAN

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    FARMABIOS SPA
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    25933
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    2013-08-08
    2012-12-17
    2012-03-27
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    ChemOutsourcing

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    CANNABIDIOL

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    34029
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    2019-07-24
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    ChemOutsourcing

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    CEFUROXIME SODIUM STERILE USP

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    FARMABIOS SPA
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    ChemOutsourcing

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    CELECOXIB USP

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    PHARMAZELL INDIA PRIV...
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    ChemOutsourcing

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    CLOBETASOL PROPIONATE

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    FARMABIOS SPA
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    8336
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    2015-02-23
    2015-02-17
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    ChemOutsourcing

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    CLOCORTOLONE PIVALATE (MICRONIZED)

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    FARMABIOS SPA
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    22421
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    ChemOutsourcing

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    CYPROTERONE ACETATE

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    FARMABIOS SPA
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    18043
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    2005-02-01
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    ChemOutsourcing

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    DELTA-1-CORTIENIC ACID

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    FARMABIOS SPA
    Active
    27008
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    2013-03-21
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    Axplora CB

    ChemOutsourcing

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    DESONIDE DRUG SUBSTANCE

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    FARMABIOS SPA
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    19574
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    2014-09-03
    2006-07-06
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    DESOXIMETASONE

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    17759
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    2012-11-28
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    ChemOutsourcing

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    DEXAMETHASONE USP

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    FARMABIOS SPA
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    31532
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    2018-03-15
    2017-03-10
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    DIFLUPREDNATE (MICRONIZED)

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    FARMABIOS SPA
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    25228
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    2014-08-27
    2014-04-14
    2011-08-23
    II
    Axplora CB

    ChemOutsourcing

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    EPOXIDE DESOXYMETASONE (INTERMEDIAT...

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    FARMABIOS SPA
    Active
    33961
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    2019-06-26
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    Axplora CB

    ChemOutsourcing

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    ESMOLOL HYDROCHLORIDE

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    FINORGA SAS
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    6868
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    2020-02-28
    2020-02-24
    1987-01-20
    II
    Axplora CB

    ChemOutsourcing

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    EXEMESTANE MICRONIZED USP

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    FARMABIOS SPA
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    26291
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    2014-03-15
    2013-11-14
    2012-07-26
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    Axplora CB

    ChemOutsourcing

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    FLUDROCORTISONE ACETATE

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    FARMABIOS SPA
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    14136
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    1999-05-12
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    Axplora CB

    ChemOutsourcing

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    FLUMETHASONE

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    FARMABIOS SPA
    Active
    15534
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    2001-07-18
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    Axplora CB

    ChemOutsourcing

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    FLUNISOLIDE ANHYDROUS USP

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    FARMABIOS SPA
    Active
    19477
    Complete
    2013-03-07
    2013-02-15
    2006-05-31
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    Axplora CB

    ChemOutsourcing

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    FLUNISOLIDE HEMIHYDRATE (MICRONIZED...

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    FARMABIOS SPA
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    26148
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    2014-06-02
    2014-05-27
    2012-06-12
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    Axplora CB

    ChemOutsourcing

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    FLUOCINOLONE ACETONIDE

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    FARMABIOS SPA
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    17395
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    2013-05-16
    2013-05-07
    2004-05-19
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    Axplora CB

    ChemOutsourcing

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    FLUOCINONIDE, MICRONIZED BP/USP

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    FARMABIOS SPA
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    21430
    Complete
    2014-08-20
    2014-01-16
    2008-03-13
    II
    Axplora CB

    ChemOutsourcing

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    FLUOROMETHOLONE

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    FARMABIOS SPA
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    35780
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    2021-04-13
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    Axplora CB

    ChemOutsourcing

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    FLURANDRENOLIDE

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    FARMABIOS SPA
    Active
    16492
    Complete
    2012-10-23
    2012-11-28
    2003-03-26
    II
    Axplora CB

    ChemOutsourcing

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    FLUTICASONE PROPIONATE USP/PH.EUR. ...

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    FARMABIOS SPA
    Active
    20463
    Complete
    2018-11-02
    2018-10-31
    2007-04-24
    II
    Axplora CB

    ChemOutsourcing

    Booth #58

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    FORMOTEROL FUMARATE

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    FARMABIOS SPA
    Active
    32936
    N/A
    2018-07-27
    II
    Axplora CB

    ChemOutsourcing

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    FULVESTRANT

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    32949
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    2020-12-29
    2020-07-17
    2018-07-27
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    Axplora CB

    ChemOutsourcing

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    HALCINONIDE

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    FARMABIOS SPA
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    18352
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    2016-11-10
    2016-09-29
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    ChemOutsourcing

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    HYDROCORTISONE HEMISUCCINATE

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    FARMABIOS SPA
    Active
    37639
    N/A
    2023-01-24
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    Axplora CB

    ChemOutsourcing

    Booth #58

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    • FDA
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    ICOSAPENT ETHYL

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    FINORGA SAS
    Active
    27182
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    2023-06-07
    2023-06-05
    2013-05-23
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    Axplora CB

    ChemOutsourcing

    Booth #58

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    LOTEPREDNOL ETABONATE

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    FARMABIOS SPA
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    26937
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    2013-03-05
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    ChemOutsourcing

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    LOTEPREDNOL ETABONATE STERILE MICRO...

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    FARMABIOS SPA
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    27717
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    2023-07-05
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    2013-11-11
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    ChemOutsourcing

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    MEDROXYPROGESTERONE ACETATE

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    FARMABIOS SPA
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    12695
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    1997-10-15
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    Axplora CB

    ChemOutsourcing

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    MEGESTROL ACETATE

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    FARMABIOS SPA
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    12662
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    2021-03-25
    2021-03-22
    1997-09-20
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    ChemOutsourcing

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    MELPHALAN HYDROCHLORIDE

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    25791
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    2014-02-21
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    2012-02-14
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    ChemOutsourcing

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    METHYLENE BLUE USP

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    PHARMAZELL GMBH
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    32900
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    2023-12-26
    2023-09-26
    2023-09-21
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    ChemOutsourcing

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    METHYLPREDNISOLONE ACETATE STERILE

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    2014-06-23
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    2013-07-19
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    ChemOutsourcing

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    METHYLTESTOSTERONE (MICRONIZED)

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    MIVACURIUM CHLORIDE

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    20232
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    2016-03-02
    2016-02-23
    2007-01-31
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    Axplora CB

    ChemOutsourcing

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    MOMETASONE FUROATE

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    FARMABIOS SPA
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    22319
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    2014-03-31
    2014-03-20
    2008-12-18
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    Axplora CB

    ChemOutsourcing

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    MOMETASONE FUROATE (ALTERNATE PROCE...

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    FARMABIOS SPA
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    33446
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    2019-12-09
    2019-09-18
    2019-03-11
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    Axplora CB

    ChemOutsourcing

    Booth #58

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    N-ACETYL-L-CYSTEINE

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    PHARMAZELL GMBH
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    5836
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    2014-08-07
    2013-04-03
    1985-03-29
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    Axplora CB

    ChemOutsourcing

    Booth #58

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