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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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    01 "Japan-station" L- carboxymethyl cysteine ​​(production only) (1)

    02 Acetylcysteine (1)

    03 Amcinonide (1)

    04 Atenolol (1)

    05 Betamethasone Valerate (1)

    06 Betaxolol hydrochloride (1)

    07 Chlormadinone Acetate (1)

    08 Diflucortolone Valerate Micronized (1)

    09 Diflucortolone valerate (1)

    10 Difluprednate (1)

    11 Fluocinolone Acetonide (1)

    12 Fluocinonide (1)

    13 Flurandrenolide (1)

    14 L- carbocisteine (2)

    15 Medroxyprogesterone acetate (1)

    16 Mesalazine (3)

    17 Prednisolone valerate acetate (1)

    18 Produced only clobetasol propionate (1)

    19 Triamcinolone Acetonide (1)

    20 Triamcinolone acetonide sterile (1)

    21 Ursodeoxycholic acid URSODEOXYCHOLIC ACID (1)

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    01 FINORGA S. A. S. (1)

    02 Farmabios S. p. A. (15)

    03 PharmaZell (India) Private Limited (5)

    04 PharmaZell GmbH (3)

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    01 France (1)

    02 Germany (4)

    03 India (5)

    04 Italy (14)

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

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

    Iran Expo

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    Acetylcysteine

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    PharmaZell GmbH
    2007-12-19
    2007-12-19
    219MF10377
    ROSENHEIMER STR. 43, D-83...
    Axplora CB

    Iran Expo

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    Amcinonide

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    Farmabios S. p. A.
    2023-04-12
    2023-04-12
    305MF10048
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    Iran Expo

    Not Confirmed

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    Atenolol

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

    Iran Expo

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    Betamethasone Valerate

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    Farmabios S. p. A.
    2022-07-06
    2022-07-06
    304MF10098
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    Iran Expo

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    Betaxolol hydrochloride

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    FINORGA S. A. S.
    2007-10-05
    2007-10-05
    219MF10314
    Route de Givors-B. P. 9-3...
    Axplora CB

    Iran Expo

    Not Confirmed

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    Chlormadinone Acetate

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

    Iran Expo

    Not Confirmed

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    Diflucortolone valerate

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    Farmabios S. p. A.
    2008-07-31
    2008-07-31
    220MF10182
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    Iran Expo

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    Diflucortolone Valerate Micronized

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    Farmabios S. p. A.
    2022-05-18
    2022-05-18
    304MF10077
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    Iran Expo

    Not Confirmed

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    Difluprednate

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    Farmabios S. p. A.
    2019-08-20
    2019-08-20
    301MF10046
    Via Pavia, 1-27027 Gropel...
    Axplora CB

    Iran Expo

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