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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by K.D. Pharma Bexbach GmbH

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    K.D. PHARMA BEXBACH GMBH

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    K.D. Pharma Bexbach GmbH
    Germany Flag
    Country
    Country
    Germany
    Address
    Address
    KD-Pharma GmbH Am Kraftwerk 6 D-66450 Bexbach, Germany
    Telephone
    Telephone
    49 (0) 6826979700
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.kd-pharma.com/
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    Linkedin
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    • FDA
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    Icosapent Ethyl

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    USDMF

    Found USDMF

    26892
    Active
    EICOSAPENTAENOIC ACID ETHYL ESTER
    2013-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10081
    Eicosapentaenoic acid ethyl at Am K...
    2016-04-06
    Written Confirmation

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    Application Number
    26892
    228MF10081
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EICOSAPENTAENOIC ACID ETHYL ESTER
    Eicosapentaenoic acid ethyl at Am K...
    Issue/Submission Date
    2013-02-26
    2016-04-06
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    • FDA
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    Icosapent Ethyl

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    USDMF

    Found USDMF

    28140
    Active
    EPA 550/DHA 200 FFA
    2014-03-31
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28140
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPA 550/DHA 200 FFA
    Issue/Submission Date
    2014-03-31
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    • FDA
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    Omega-3

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    USDMF

    Found USDMF

    22100
    Active
    OMEGA-3 ACIDS ETHYL ESTERS USP
    2008-11-07
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    22100
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OMEGA-3 ACIDS ETHYL ESTERS USP
    Issue/Submission Date
    2008-11-07
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-042 - Rev 00
    Valid
    Omega-3-acid ethyl esters 60, Conta...
    2015-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-042 - Rev 00
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 60, Conta...
    Issue/Submission Date
    2015-12-14
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-118 - Rev 01
    Valid
    Omega-3-acid ethyl esters 90, Conta...
    2021-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2015-118 - Rev 01
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, Conta...
    Issue/Submission Date
    2021-11-16
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2009-326 - Rev 01
    Valid
    Omega-3-acid ethyl esters 60, Conta...
    2016-03-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-326 - Rev 01
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 60, Conta...
    Issue/Submission Date
    2016-03-03
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-327 - Rev 03
    Valid
    Omega-3-acid ethyl esters 90, Conta...
    2021-11-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-327 - Rev 03
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, Conta...
    Issue/Submission Date
    2021-11-30
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-328 - Rev 03
    Valid
    Omega-3-acid ethyl esters 90, Conta...
    2021-11-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-328 - Rev 03
    Status
    Valid
     
    Filing Details
    Omega-3-acid ethyl esters 90, Conta...
    Issue/Submission Date
    2021-11-24
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    • FDA
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    OMEGA-3-ACIDS ETHYL ESTER

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    USDMF

    Caution USDMF

    23905
    Inactive
    OMEGA-3-ACIDS ETHYL ESTER
    2010-07-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    23905
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OMEGA-3-ACIDS ETHYL ESTER
    Issue/Submission Date
    2010-07-12
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