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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius SE & Co. KGaA

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    FRESENIUS SE & CO. KGAA

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    Fresenius SE & Co. KGaA
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    Country
    Germany
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    Address
    Else-Kröner-Str. 1 61352 Bad Homburg
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    Telephone
    +49 6172 608-0
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    enquiries@pharmacompass.com
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    https://www.fresenius.com/
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    Gemcitabine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2008-131 - Rev 04
    Valid
    Gemcitabine hydrochloride
    2022-02-11
    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0115
    Expired
    Gemcitabine Hydrochloride (Ph. Eur....
    2019-07-08
    Application Number
    R1-CEP 2008-131 - Rev 04
    Indian CDSCO WC-0115
    Status
    Valid
     
    Expired
    2022-07-07
    Filing Details
    Gemcitabine hydrochloride
    Gemcitabine Hydrochloride (Ph. Eur....
    Issue/Submission Date
    2022-02-11
    2019-07-08
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    Gemcitabine

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    USDMF

    Found USDMF

    21399
    Active
    GEMCITABINE HYDROCHLORIDE
    2008-04-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    21399
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE
    Issue/Submission Date
    2008-04-22
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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2023-271 - Rev 00
    Valid
    Gemcitabine hydrochloride, Alternat...
    2023-12-06
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2023-271 - Rev 00
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride, Alternat...
    Issue/Submission Date
    2023-12-06
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    Gemcitabine

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2012-080 - Rev 01
    Valid
    Gemcitabine hydrochloride, Alternat...
    2019-10-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-080 - Rev 01
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride, Alternat...
    Issue/Submission Date
    2019-10-08
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    Gemcitabine

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    224MF10032
    Gemcitabine hydrochloride at Echelo...
    2012-02-15
    Written Confirmation

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    Application Number
    224MF10032
    Status
     
    Filing Details
    Gemcitabine hydrochloride at Echelo...
    Issue/Submission Date
    2012-02-15
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