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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Samyang Biopharmaceuticals

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    01 Docetaxel (2)

    02 Paclitaxel (2)

    03 Pemetrexed Disodium (2)

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    01 Active (3)

    02 Inactive (1)

    03 Blank (2)

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    01 Expired (2)

    02 Blank (4)

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    01 221MF10165 (1)

    02 224MF10143 (1)

    03 302MF10055 (1)

    04 302MF10105 (1)

    05 Blank (2)

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    01 Blank (6)

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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25672
    Active
    DOCETAXEL ANHYDROUS
    2012-01-04
    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-240 - Rev 01
    Expired
    Docetaxel trihydrate
    2014-06-26
    Japanese DMF

    Found JDMF

    224MF10143
    Docetaxel at 31 Jongno 33-gil, Jong...
    2012-07-31
    Written Confirmation

    Close WC

    Application Number
    25672
    R0-CEP 2012-240 - Rev 01
    224MF10143
    Status
    Active
    Fees Unpaid
    N/A
    Expired
     
    Filing Details
    DOCETAXEL ANHYDROUS
    Docetaxel trihydrate
    Docetaxel at 31 Jongno 33-gil, Jong...
    Issue/Submission Date
    2012-01-04
    2014-06-26
    2012-07-31
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    Paclitaxel

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    USDMF

    Found USDMF

    14338
    Active
    PACLITAXEL
    1999-08-04
    CEP/COS

    Caution CEP/COS

    R0-CEP 2014-061 - Rev 00
    Expired
    Paclitaxel, Produced by a semi-synt...
    2016-01-14
    Japanese DMF

    Found JDMF

    221MF10165
    Paclitaxel at 31 Jongno 33-gil, Jon...
    2009-07-23
    Written Confirmation

    Close WC

    Application Number
    14338
    R0-CEP 2014-061 - Rev 00
    221MF10165
    Status
    Active
    Fees Unpaid
    N/A
    Expired
     
    Filing Details
    PACLITAXEL
    Paclitaxel, Produced by a semi-synt...
    Paclitaxel at 31 Jongno 33-gil, Jon...
    Issue/Submission Date
    1999-08-04
    2016-01-14
    2009-07-23
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    Paclitaxel

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    USDMF

    Found USDMF

    27560
    Active
    SEMISYNTHETIC PACLITAXEL
    2013-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27560
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SEMISYNTHETIC PACLITAXEL
    Issue/Submission Date
    2013-09-16
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    Pemetrexed Disodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10105
    Pemetrexed sodium hemipenta hydrate...
    2020-08-27
    Written Confirmation

    Close WC

    Application Number
    302MF10105
    Status
     
    Filing Details
    Pemetrexed sodium hemipenta hydrate...
    Issue/Submission Date
    2020-08-27
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    Pemetrexed Disodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    302MF10055
    Pemetrexed sodium hydrate at 295, P...
    2020-05-12
    Written Confirmation

    Close WC

    Application Number
    302MF10055
    Status
     
    Filing Details
    Pemetrexed sodium hydrate at 295, P...
    Issue/Submission Date
    2020-05-12
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25678
    Inactive
    DOCETAXEL TRIHYDRATE
    2012-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25678
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DOCETAXEL TRIHYDRATE
    Issue/Submission Date
    2012-01-04
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