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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hansoh Pharma

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    01 Azacitidine (1)

    02 Bortezomib (1)

    03 Dapagliflozin (1)

    04 Decitabine (1)

    05 Degarelix Acetate (1)

    06 Duloxetine (1)

    07 Fulvestrant (1)

    08 Gemcitabine (2)

    09 Icatibant Acetate (1)

    10 Micafungin (2)

    11 Nintedanib Esylate (1)

    12 Olanzapine (2)

    13 Pemetrexed (1)

    14 Pemetrexed Disodium (2)

    15 Vinorelbine Tartrate (2)

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    01 Active (15)

    02 Inactive (5)

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    01 Valid (4)

    02 Blank (16)

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    01 226MF10027 (1)

    02 227MF10033 (1)

    03 227MF10138 (1)

    04 229MF10063 (1)

    05 230MF10045 (1)

    06 303MF10173 (1)

    07 Blank (14)

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    01 Blank (20)

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    • FDA
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    Pemetrexed Disodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29183
    Active
    PEMETREXED DISODIUM HEMIPENTAHYDRAT...
    2015-06-10
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-265 - Rev 00
    Valid
    Pemetrexed disodium heptahydrate
    2023-06-19
    Japanese DMF

    Found JDMF

    227MF10138
    Pemetrexed Sodium Hemipentahydrate ...
    2015-05-14
    Written Confirmation

    Close WC

    Application Number
    29183
    R0-CEP 2022-265 - Rev 00
    227MF10138
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PEMETREXED DISODIUM HEMIPENTAHYDRAT...
    Pemetrexed disodium heptahydrate
    Pemetrexed Sodium Hemipentahydrate ...
    Issue/Submission Date
    2015-06-10
    2023-06-19
    2015-05-14
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    • FDA
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    Gemcitabine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    18810
    Inactive
    GEMCITABINE HYDROCHLORIDE USP (NON-...
    2005-09-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-076 - Rev 00
    Valid
    Gemcitabine hydrochloride
    2023-02-28
    Japanese DMF

    Found JDMF

    229MF10063
    Gemcitabine Hydrochloride at 9 Dong...
    2017-03-07
    Written Confirmation

    Close WC

    Application Number
    18810
    R1-CEP 2017-076 - Rev 00
    229MF10063
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP (NON-...
    Gemcitabine hydrochloride
    Gemcitabine Hydrochloride at 9 Dong...
    Issue/Submission Date
    2005-09-24
    2023-02-28
    2017-03-07
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    Vinorelbine Tartrate

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    USDMF

    Caution USDMF

    16011
    Inactive
    VINORELBINE TARTRATE USP
    2002-06-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-075 - Rev 00
    Valid
    Vinorelbine tartrate
    2023-02-21
    Japanese DMF

    Found JDMF

    303MF10173
    Vinorelbine Startrate at 9 Dongjin ...
    2021-12-09
    Written Confirmation

    Close WC

    Application Number
    16011
    R1-CEP 2017-075 - Rev 00
    303MF10173
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    VINORELBINE TARTRATE USP
    Vinorelbine tartrate
    Vinorelbine Startrate at 9 Dongjin ...
    Issue/Submission Date
    2002-06-14
    2023-02-21
    2021-12-09
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    Bortezomib

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    USDMF

    Found USDMF

    32275
    Active
    BORTEZOMIB
    2018-01-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10045
    Bortezomib at 9 Dongjin Road, Econo...
    2018-03-22
    Written Confirmation

    Close WC

    Application Number
    32275
    230MF10045
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BORTEZOMIB
    Bortezomib at 9 Dongjin Road, Econo...
    Issue/Submission Date
    2018-01-19
    2018-03-22
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    Fulvestrant

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34053
    Active
    FULVESTRANT USP, NON-STERILE BULK D...
    2019-09-05
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-036 - Rev 00
    Valid
    Fulvestrant
    2020-12-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34053
    R0-CEP 2020-036 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FULVESTRANT USP, NON-STERILE BULK D...
    Fulvestrant
    Issue/Submission Date
    2019-09-05
    2020-12-21
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    Vinorelbine Tartrate

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    USDMF

    Found USDMF

    31480
    Active
    VINORELBINE TARTRATE, USP
    2017-04-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10027
    Vinorelbine tartrate at 9 Dongjin R...
    2014-02-05
    Written Confirmation

    Close WC

    Application Number
    31480
    226MF10027
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VINORELBINE TARTRATE, USP
    Vinorelbine tartrate at 9 Dongjin R...
    Issue/Submission Date
    2017-04-13
    2014-02-05
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    Olanzapine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24480
    Inactive
    OLANZAPINE NON-STERILE BULK DRUG SU...
    2010-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10033
    Olanzapine at No. 9 Dongjin Road, E...
    2015-01-23
    Written Confirmation

    Close WC

    Application Number
    24480
    227MF10033
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OLANZAPINE NON-STERILE BULK DRUG SU...
    Olanzapine at No. 9 Dongjin Road, E...
    Issue/Submission Date
    2010-12-20
    2015-01-23
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    Azacitidine

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    USDMF

    Found USDMF

    32864
    Active
    AZACITIDINE, NON-STERILE BULK DRUG ...
    2018-09-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32864
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AZACITIDINE, NON-STERILE BULK DRUG ...
    Issue/Submission Date
    2018-09-21
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    Dapagliflozin

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    USDMF

    Found USDMF

    32117
    Active
    DAPAGLIFLOZIN
    2017-11-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32117
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN
    Issue/Submission Date
    2017-11-21
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    Decitabine

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    USDMF

    Found USDMF

    32285
    Active
    DECITABINE, NON-STERILE BULK DRUG S...
    2018-05-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32285
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DECITABINE, NON-STERILE BULK DRUG S...
    Issue/Submission Date
    2018-05-21
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