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

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    01 3-FORMYL-5-METHOXYINDOLE INTERMEDIATE (1)

    02 ARTICAINE HYDROCHLORIDE DRUG SUBSTANCE (1)

    03 ETHIONAMIDE DRUG SUBSTANCE (1)

    04 FENOFIBRATE DRUG SUBSTANCE (1)

    05 HEMATOPORPHYRIN DIHYDROCHLORIDE (1)

    06 LAMOTRIGINE DRUG SUBSTANCE (1)

    07 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CEDEX, FRANCE. (1)

    08 METHYL SULFONAMIDE INDOLE-2- CAROXYLIC ACID (1)

    09 PROTOPORPHYRIN IX DIMETHYL ESTER (PPIX-DME) (1)

    10 THIOTHIXENE (1)

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    01 CALAIRE CHIMIE SAS (1)

    02 ORGAPHARM (2)

    03 ORGAPHARM SAS (6)

    04 SYNTHEXIM CALAIRE CHIMIE (1)

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    01 France (10)

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    01 Active (7)

    02 Inactive (3)

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    01 Blank (10)

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    3-FORMYL-5-METHOXYINDOLE INTERMEDIA...

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    ORGAPHARM SAS
    Active
    18848
    N/A
    2005-10-07
    II
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    ARTICAINE HYDROCHLORIDE DRUG SUBSTA...

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    ORGAPHARM SAS
    Active
    16469
    N/A
    2003-03-18
    II
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    ETHIONAMIDE DRUG SUBSTANCE

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    ORGAPHARM SAS
    Active
    23640
    N/A
    2010-03-17
    II
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    FENOFIBRATE DRUG SUBSTANCE

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    ORGAPHARM
    Inactive
    14157
    N/A
    1999-05-26
    II
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    HEMATOPORPHYRIN DIHYDROCHLORIDE

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    ORGAPHARM
    Active
    11008
    N/A
    1994-07-26
    II
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    LAMOTRIGINE DRUG SUBSTANCE

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    SYNTHEXIM CALAIRE CHI...
    Active
    23740
    N/A
    2010-04-22
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    METHYL SULFONAMIDE INDOLE-2- CAROXY...

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    ORGAPHARM SAS
    Inactive
    10929
    N/A
    1994-06-02
    II
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    PROTOPORPHYRIN IX DIMETHYL ESTER (P...

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    ORGAPHARM SAS
    Active
    20372
    N/A
    2007-03-16
    II
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    THIOTHIXENE

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    ORGAPHARM SAS
    Active
    5566
    N/A
    1984-09-28
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    MANUFACTURING SITE, FACILITIES, PER...

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    CALAIRE CHIMIE SAS
    Inactive
    11633
    N/A
    1995-08-25
    II
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