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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Orgapharm & Kyrapharm

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    01 5-Methoxyindole-3-Carboxaldehyde (1)

    02 Articaine Hydrochloride (1)

    03 CAS 150975-95-4 (1)

    04 Ethionamide (1)

    05 Fenofibrate (1)

    06 Flecainide (1)

    07 Glibenclamide (1)

    08 Hematoporphyrin Dihydrochloride (1)

    09 Protoporphyrin IX Dimethyl Ester (1)

    10 Thiothixene (1)

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    01 Active (6)

    02 Inactive (2)

    03 Blank (2)

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    01 Valid (3)

    02 Blank (7)

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    01 Blank (10)

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    01 Blank (10)

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    Articaine Hydrochloride

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    USDMF

    Found USDMF

    16469
    Active
    ARTICAINE HYDROCHLORIDE DRUG SUBSTA...
    2003-03-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-191 - Rev 01
    Valid
    Articaine hydrochloride
    2012-10-01
    Japanese DMF

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    Written Confirmation

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    Application Number
    16469
    R1-CEP 2003-191 - Rev 01
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    ARTICAINE HYDROCHLORIDE DRUG SUBSTA...
    Articaine hydrochloride
    Issue/Submission Date
    2003-03-18
    2012-10-01
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    5-Methoxyindole-3-Carboxaldehyde

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    USDMF

    Found USDMF

    18848
    Active
    3-FORMYL-5-METHOXYINDOLE INTERMEDIA...
    2005-10-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    18848
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    3-FORMYL-5-METHOXYINDOLE INTERMEDIA...
    Issue/Submission Date
    2005-10-07
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    Ethionamide

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    USDMF

    Found USDMF

    23640
    Active
    ETHIONAMIDE DRUG SUBSTANCE
    2010-03-17
    CEP/COS

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    Application Number
    23640
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ETHIONAMIDE DRUG SUBSTANCE
    Issue/Submission Date
    2010-03-17
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    Flecainide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2005-278 - Rev 07
    Valid
    Flecainide acetate
    2019-08-30
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2005-278 - Rev 07
    Status
    Valid
     
    Filing Details
    Flecainide acetate
    Issue/Submission Date
    2019-08-30
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    Glibenclamide

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2006-134 - Rev 02
    Valid
    Glibenclamide, Micronised
    2013-07-19
    Japanese DMF

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    Application Number
    R1-CEP 2006-134 - Rev 02
    Status
    Valid
     
    Filing Details
    Glibenclamide, Micronised
    Issue/Submission Date
    2013-07-19
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    Hematoporphyrin Dihydrochloride

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    USDMF

    Found USDMF

    11008
    Active
    HEMATOPORPHYRIN DIHYDROCHLORIDE
    1994-07-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    11008
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    HEMATOPORPHYRIN DIHYDROCHLORIDE
    Issue/Submission Date
    1994-07-26
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    Protoporphyrin IX Dimethyl Ester

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    USDMF

    Found USDMF

    20372
    Active
    PROTOPORPHYRIN IX DIMETHYL ESTER (P...
    2007-03-16
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    20372
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    PROTOPORPHYRIN IX DIMETHYL ESTER (P...
    Issue/Submission Date
    2007-03-16
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    Thiothixene

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    USDMF

    Found USDMF

    5566
    Active
    THIOTHIXENE
    1984-09-28
    CEP/COS

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    Japanese DMF

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    Application Number
    5566
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    THIOTHIXENE
    Issue/Submission Date
    1984-09-28
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    CAS 150975-95-4

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    USDMF

    Caution USDMF

    10929
    Inactive
    METHYL SULFONAMIDE INDOLE-2- CAROXY...
    1994-06-02
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    10929
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    METHYL SULFONAMIDE INDOLE-2- CAROXY...
    Issue/Submission Date
    1994-06-02
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    Fenofibrate

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    USDMF

    Caution USDMF

    14157
    Inactive
    FENOFIBRATE DRUG SUBSTANCE
    1999-05-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    14157
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    FENOFIBRATE DRUG SUBSTANCE
    Issue/Submission Date
    1999-05-26
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