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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Jiangsu Hengrui Medicine

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    01 Azelastine Hydrochloride (1)

    02 Bupivacaine (1)

    03 Capecitabine (1)

    04 Carmustine (1)

    05 Caspofungin (1)

    06 Cisatracurium Besylate (1)

    07 Cyclophosphamide (1)

    08 Desflurane (1)

    09 Dexmedetomidine Hydrochloride (1)

    10 Docetaxel (1)

    11 Etoposide (1)

    12 Fondaparinux Sodium (1)

    13 Gabapentin (1)

    14 Gadobutrol (1)

    15 Gadoterate Meglumine (1)

    16 Ifosfamide (1)

    17 Iodixanol (1)

    18 Ioversol (1)

    19 Irinotecan Hydrochloride (1)

    20 Ivabradine Hydrochloride (1)

    21 Letrozole (1)

    22 Mesna (1)

    23 Oxaliplatin (1)

    24 Rivoceranib (1)

    25 SHR0302 (1)

    26 Sevoflurane (2)

    27 Tamsulosin (1)

    28 Thiotepa (1)

    29 Tolvaptan (1)

    30 Trabectedin (1)

    31 Blank (2)

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    01 Active (23)

    02 Inactive (10)

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    01 Valid (4)

    02 Withdrawn by Holder (1)

    03 Blank (28)

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    01 222MF10210 (1)

    02 226MF10030 (1)

    03 226MF10183 (1)

    04 228MF10029 (1)

    05 231MF10009 (1)

    06 Blank (28)

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    01 Blank (33)

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    • FDA
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    Letrozole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23831
    Active
    LETROZOLE USP NON-STERILE BULK DRUG...
    2010-05-24
    CEP/COS

    Found CEP/COS

    CEP 2010-270 - Rev 04
    Valid
    Letrozole
    2023-11-08
    Japanese DMF

    Found JDMF

    226MF10030
    Letrozole at No. 7, Kunlunshan Road...
    2014-02-05
    Written Confirmation

    Close WC

    Application Number
    23831
    CEP 2010-270 - Rev 04
    226MF10030
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LETROZOLE USP NON-STERILE BULK DRUG...
    Letrozole
    Letrozole at No. 7, Kunlunshan Road...
    Issue/Submission Date
    2010-05-24
    2023-11-08
    2014-02-05
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    Oxaliplatin

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    USDMF

    Found USDMF

    20665
    Active
    OXALIPLATIN USP
    2007-07-09
    CEP/COS

    Found CEP/COS

    CEP 2005-079 - Rev 03
    Valid
    Oxaliplatin
    2023-11-08
    Japanese DMF

    Found JDMF

    222MF10210
    Oxaliplatin at No. 7, Kunlunshan Ro...
    2010-08-04
    Written Confirmation

    Close WC

    Application Number
    20665
    CEP 2005-079 - Rev 03
    222MF10210
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXALIPLATIN USP
    Oxaliplatin
    Oxaliplatin at No. 7, Kunlunshan Ro...
    Issue/Submission Date
    2007-07-09
    2023-11-08
    2010-08-04
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    Sevoflurane

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    USDMF

    Caution USDMF

    24903
    Inactive
    SEVOFLURANE USP, NON-STERILE, BULK ...
    2011-04-29
    CEP/COS

    Found CEP/COS

    CEP 2016-297 - Rev 01
    Valid
    Sevoflurane
    2023-11-08
    Japanese DMF

    Found JDMF

    231MF10009
    Sevoflurane “Hengrui” at No. 7,...
    2019-01-10
    Written Confirmation

    Close WC

    Application Number
    24903
    CEP 2016-297 - Rev 01
    231MF10009
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SEVOFLURANE USP, NON-STERILE, BULK ...
    Sevoflurane
    Sevoflurane “Hengrui” at No. 7,...
    Issue/Submission Date
    2011-04-29
    2023-11-08
    2019-01-10
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    26377
    Active
    DEXMEDETOMIDINE HYDROCHLORIDE USP, ...
    2012-09-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10029
    Dexmedetomidine Hydrochloride at N...
    2016-02-02
    Written Confirmation

    Close WC

    Application Number
    26377
    228MF10029
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXMEDETOMIDINE HYDROCHLORIDE USP, ...
    Dexmedetomidine Hydrochloride at N...
    Issue/Submission Date
    2012-09-04
    2016-02-02
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    Etoposide

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    USDMF

    Found USDMF

    8647
    Active
    ETOPOSIDE USP
    1990-07-02
    CEP/COS

    Found CEP/COS

    CEP 2008-037 - Rev 05
    Valid
    Etoposide
    2023-10-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8647
    CEP 2008-037 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ETOPOSIDE USP
    Etoposide
    Issue/Submission Date
    1990-07-02
    2023-10-09
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    Irinotecan Hydrochloride

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    USDMF

    Found USDMF

    20739
    Active
    IRINOTECAN HYDROCHLORIDE USP (NON-S...
    2007-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10183
    Irinotecan hydrochloride hydrate "H...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    20739
    226MF10183
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IRINOTECAN HYDROCHLORIDE USP (NON-S...
    Irinotecan hydrochloride hydrate "H...
    Issue/Submission Date
    2007-08-01
    2014-09-30
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    Ifosfamide

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    USDMF

    Found USDMF

    11290
    Active
    IFOSFAMIDE USP, NON-STERILE, BULK D...
    1995-01-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2013-026 - Rev 00
    Withdrawn by Holder
    Ifosfamide
    2019-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11290
    R1-CEP 2013-026 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    IFOSFAMIDE USP, NON-STERILE, BULK D...
    Ifosfamide
    Issue/Submission Date
    1995-01-11
    2019-09-04
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    Bupivacaine

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    USDMF

    Found USDMF

    34900
    Active
    BUPIVACAINE BASE
    2020-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34900
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPIVACAINE BASE
    Issue/Submission Date
    2020-06-29
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    Carmustine

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    USDMF

    Found USDMF

    32031
    Active
    CARMUSTINE USP NON STERILE BULK DRU...
    2017-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32031
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARMUSTINE USP NON STERILE BULK DRU...
    Issue/Submission Date
    2017-10-27
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    Caspofungin

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    USDMF

    Found USDMF

    28472
    Active
    CASPOFUNGIN ACETATE
    2014-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28472
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CASPOFUNGIN ACETATE
    Issue/Submission Date
    2014-11-20
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