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    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Axplora to the Review Authority in Japan (PMDA). Original Data : PMDA

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Acetylcysteine

    • Beclomethasone Dipropionate

    • Carbocisteine

    • Diflucortolone Valerate

    • Icosapent Ethyl

    • Medroxyprogesterone Acetate

    • Megestrol Acetate

    • Mesalazine

    • Nitroglycerin

    • Omega-3-Acid Ethyl Esters 90

    • Propafenone Hydrochloride

    • Triamcinolone

    • Triamcinolone Acetonide

    • Triamcinolone Diacetate

    • Triamcinolone Hexacetonide

    • Ursodeoxycholic Acid

    INTERMEDIATES

    SERVICES

    Key Products KEY SERVICES

    • Complex API Development Services

    • Development of Small Molecule APIs

    • API Custom Synthesis

    • Hazardous Chemistry

    • Flow Chemistry

    • Industrial Chromatography

    • Contract Development & Manufacturing for ADCs

    EXCIPIENTS

    INSPECTIONS & REGISTRATIONS

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    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    "Japan-station" L- carboxymethyl cysteine ​​(produc...

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell (India) Privat...
    2008-02-25
    2006-01-27
    218MF10008
    Plot No. B5 & B6, MEPZ, T...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Acetylcysteine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell GmbH
    2007-12-19
    2007-12-19
    219MF10377
    ROSENHEIMER STR. 43, D-83...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Amcinonide

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2023-04-12
    2023-04-12
    305MF10048
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Atenolol

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell (India) Privat...
    2008-01-09
    2008-01-09
    220MF10018
    Plot No. B5 & B6, MEPZ, T...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Betamethasone Valerate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2022-07-06
    2022-07-06
    304MF10098
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Betaxolol hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    FINORGA S. A. S.
    2007-10-05
    2007-10-05
    219MF10314
    Route de Givors-B. P. 9-3...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Chlormadinone Acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2019-07-04
    2006-12-18
    218MF10991
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Diflucortolone valerate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2008-07-31
    2008-07-31
    220MF10182
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    Diflucortolone Valerate Micronized

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2022-05-18
    2022-05-18
    304MF10077
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Difluprednate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2019-08-20
    2019-08-20
    301MF10046
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Fluocinolone Acetonide

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2010-03-17
    2006-04-27
    218MF10445
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Fluocinonide

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2010-03-17
    2006-04-27
    218MF10444
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Flurandrenolide

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2008-06-10
    2008-06-10
    220MF10142
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    L- carbocisteine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell (India) Privat...
    2021-07-16
    2015-07-13
    227MF10185
    Plot No. B5 & B6, MEPZ, T...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    L- carbocisteine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell (India) Privat...
    2021-07-16
    2013-11-14
    225MF10208
    Plot No. B5&B6, MEPZ, Tam...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Medroxyprogesterone acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2019-05-27
    2010-03-17
    222MF10098
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell GmbH
    2014-01-21
    2014-01-21
    226MF10019
    ROSENHEIMER STR. 43 D-830...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell (India) Privat...
    2014-03-11
    2014-03-11
    226MF10064
    Plot No. 115, Ramky Pharm...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
    PharmaZell GmbH
    2016-02-02
    2007-02-13
    219MF10036
    ROSENHEIMER STR. 43 D-830...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
    • WHO-GMP
    Virtual BoothAxplora- The partner of choice for complex APIs.

    Prednisolone valerate acetate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2009-01-13
    2009-01-13
    221MF10010
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Produced only clobetasol propionate

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2019-04-09
    2010-04-12
    222MF10130
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
    • EDQM
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    Virtual BoothAxplora- The partner of choice for complex APIs.

    Triamcinolone Acetonide

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2023-07-19
    2023-07-19
    305MF10085
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    Contact Supplier
    • FDA
    • EDQM
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    Triamcinolone acetonide sterile

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2020-01-31
    2011-04-12
    223MF10049
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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    • FDA
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    Ursodeoxycholic acid URSODEOXYCHOLIC ACID

    PDF Supplier PDF
    URL Supplier Web Content
    Farmabios S. p. A.
    2022-06-28
    2021-04-27
    303MF10073
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    PEAK 2024

    Not Confirmed

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