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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Jiangsu Hengrui Medicine to the U.S. FDA. Original Data : FDA Website

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    01 AZELASTINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE (1)

    02 BUPIVACAINE BASE (1)

    03 CAPECITABINE USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    04 CARMUSTINE USP NON STERILE BULK DRUG SUBSTANCE (1)

    05 CASPOFUNGIN ACETATE (1)

    06 CISATRACURIUM BESYLATE, USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    07 COREY 16 (1)

    08 CYCLOPHOSPHAMIDE, USP, STERILE, BULK DRUG SUBSTANCE (1)

    09 DESFLURANE, USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    10 DEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    11 DOCETAXEL TRIHYDRATE USP (1)

    12 ETOPOSIDE USP (1)

    13 FONDAPARINUX SODIUM USP, NON-STERILE BULK DRUG SUBSTANCE (1)

    14 GABAPENTIN, USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    15 GADOBUTROL USP (1)

    16 GADOTERATE MEGLUMINE (1)

    17 IFOSFAMIDE USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    18 IODIXANOL USP (1)

    19 IOVERSOL USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    20 IRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE (1)

    21 IVABRADINE MONOSULFATE (1)

    22 LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE (1)

    23 MESNA USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    24 OXALIPLATIN USP (1)

    25 RIVOCERANIB MESYLATE, NON-STERILE, BULK DRUG SUBSTANCE (1)

    26 SEVOFLURANE USP (1)

    27 SEVOFLURANE USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

    28 SHR0302 NON-STERILE BULK DRUG SUBSTANCE (1)

    29 SHR169106 (1)

    30 TAMSULOSIN HYDROCHLORIDE USP, NON-STERILE, BULK SUBSTANCE (1)

    31 THIOTEPA USP NON STERILE BULK DRUG (1)

    32 TOLVAPTAN (1)

    33 TRABECTEDIN, NON-STERILE, BULK DRUG SUBSTANCE (1)

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    01 CHENGDU XINYUE MEDICINE CO LTD (1)

    02 JIANGSU HENGRUI MEDICINE CO LTD (6)

    03 JIANGSU HENGRUI PHARMACEUTICALS CO LTD (26)

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    01 China (32)

    02 U.S.A (1)

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    01 Active (23)

    02 Inactive (10)

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    01 Complete (16)

    02 Blank (17)

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    AZELASTINE HYDROCHLORIDE, NON-STERI...

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    JIANGSU HENGRUI MEDIC...
    Inactive
    25626
    N/A
    2011-12-23
    II
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    BUPIVACAINE BASE

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    JIANGSU HENGRUI PHARM...
    Active
    34900
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    2020-08-06
    2020-06-19
    2020-06-29
    II
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    CAPECITABINE USP, NON-STERILE, BULK...

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    JIANGSU HENGRUI MEDIC...
    Inactive
    25521
    N/A
    2011-11-22
    II
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    CARMUSTINE USP NON STERILE BULK DRU...

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    JIANGSU HENGRUI PHARM...
    Active
    32031
    Complete
    2017-12-05
    2017-09-14
    2017-10-27
    II
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    CASPOFUNGIN ACETATE

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    JIANGSU HENGRUI PHARM...
    Active
    28472
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    2015-01-05
    2014-08-12
    2014-11-20
    II
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    CISATRACURIUM BESYLATE, USP, NON-ST...

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    JIANGSU HENGRUI PHARM...
    Active
    25511
    Complete
    2015-07-27
    2015-07-17
    2011-11-17
    II
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    CYCLOPHOSPHAMIDE, USP, STERILE, BUL...

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    JIANGSU HENGRUI PHARM...
    Active
    26041
    N/A
    2012-05-11
    II
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    DESFLURANE, USP, NON-STERILE, BULK ...

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    JIANGSU HENGRUI PHARM...
    Active
    28413
    Complete
    2014-10-20
    2014-07-22
    2014-09-23
    II
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    DEXMEDETOMIDINE HYDROCHLORIDE USP, ...

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    JIANGSU HENGRUI PHARM...
    Active
    26377
    Complete
    2014-05-16
    2013-04-29
    2012-09-04
    II
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    DOCETAXEL TRIHYDRATE USP

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    JIANGSU HENGRUI PHARM...
    Active
    24175
    Complete
    2014-05-12
    2012-11-30
    2010-09-13
    II
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