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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Synbias Pharma Limited Liability Company

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    Synbias Pharma Limited Liability Company

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    01 Clofarabine (1)

    02 Doxorubicin Hydrochloride (1)

    03 Epirubicin Hydrochloride (1)

    04 Idarubicin Hydrochloride (2)

    05 Nelarabine (1)

    06 Topotecan Hydrochloride (1)

    07 Valrubicin (1)

    08 Vinorelbine Tartrate (2)

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    01 Active (5)

    02 Inactive (5)

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    01 Valid (1)

    02 Blank (9)

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    01 222MF10019 (1)

    02 Blank (9)

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    01 Blank (10)

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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    16178
    Active
    DOXORUBICIN HYDROCHLORIDE
    2002-10-09
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-186 - Rev 00
    Valid
    Doxorubicin Hydrochloride
    2022-09-15
    Japanese DMF

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    Written Confirmation

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    Application Number
    16178
    R0-CEP 2020-186 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE
    Doxorubicin Hydrochloride
    Issue/Submission Date
    2002-10-09
    2022-09-15
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    Epirubicin Hydrochloride

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    USDMF

    Found USDMF

    16258
    Active
    EPIRUBICIN HYDROCHLORIDE
    2002-10-31
    CEP/COS

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    Japanese DMF

    Found JDMF

    222MF10019
    Epirubicin hydrochloride at Georgie...
    2010-01-14
    Written Confirmation

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    Application Number
    16258
    222MF10019
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPIRUBICIN HYDROCHLORIDE
    Epirubicin hydrochloride at Georgie...
    Issue/Submission Date
    2002-10-31
    2010-01-14
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    Idarubicin Hydrochloride

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    USDMF

    Found USDMF

    36526
    Active
    IDARUBICIN HCL
    2021-12-02
    CEP/COS

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    Application Number
    36526
    Status
    Active
    Fees Paid
    Reviewed
     
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    IDARUBICIN HCL
    Issue/Submission Date
    2021-12-02
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    Nelarabine

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    USDMF

    Found USDMF

    30575
    Active
    NELARABINE
    2016-05-25
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    30575
    Status
    Active
    Fees Paid
    Reviewed
     
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    NELARABINE
    Issue/Submission Date
    2016-05-25
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    Valrubicin

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    USDMF

    Found USDMF

    26918
    Active
    VALRUBICIN USP
    2013-02-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26918
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VALRUBICIN USP
    Issue/Submission Date
    2013-02-26
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    Clofarabine

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    USDMF

    Caution USDMF

    29372
    Inactive
    CLOFARABINE
    2015-05-11
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    29372
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CLOFARABINE
    Issue/Submission Date
    2015-05-11
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    Idarubicin Hydrochloride

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    USDMF

    Caution USDMF

    17504
    Inactive
    IDARUBICIN HYDROCHLORIDE
    2004-06-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    17504
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    IDARUBICIN HYDROCHLORIDE
    Issue/Submission Date
    2004-06-26
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    Topotecan Hydrochloride

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    USDMF

    Caution USDMF

    23682
    Inactive
    TOPOTECAN HYDROCHLORIDE
    2010-03-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    23682
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TOPOTECAN HYDROCHLORIDE
    Issue/Submission Date
    2010-03-29
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    Vinorelbine Tartrate

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    USDMF

    Caution USDMF

    21929
    Inactive
    VINORELBINE TARTRATE
    2008-09-01
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    21929
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    VINORELBINE TARTRATE
    Issue/Submission Date
    2008-09-01
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    Vinorelbine Tartrate

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    USDMF

    Caution USDMF

    28221
    Inactive
    VINORELBINE TARTRATE
    2014-05-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28221
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    VINORELBINE TARTRATE
    Issue/Submission Date
    2014-05-06
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