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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Hubei Biocause Heilen Pharmaceutical Co., Ltd to the U.S. FDA. Original Data : FDA Website

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    01 ABIRATERONE ACETATE (1)

    02 ATROPINE SULFATE (1)

    03 DEXIBUPROFEN DRUG SUBSTANCE (1)

    04 DEXMEDETOMIDINE DRUG SUBSTANCE (1)

    05 FLUDARABINE PHOSPHATE DRUG SUBSTANCE (1)

    06 FLUMAZENIL (1)

    07 Fludarabine Phosphate Drug Substance (1)

    08 GRANISETRON HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE (1)

    09 HOMATROPINE HYDROBROMIDE (1)

    10 HOMATROPINE METHYLBROMIDE (1)

    11 HYOSCYAMINE SULFATE (1)

    12 IBUPROFEN USP (1)

    13 MILRINONE (1)

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    01 HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD (13)

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    ABIRATERONE ACETATE

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    HUBEI BIOCAUSE HEILEN...
    Active
    27853
    Complete
    2022-08-09
    2022-06-16
    2013-12-24
    II
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    ATROPINE SULFATE

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    HUBEI BIOCAUSE HEILEN...
    Active
    28978
    Complete
    2015-12-18
    2015-08-31
    2014-12-25
    II
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    DEXIBUPROFEN DRUG SUBSTANCE

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    HUBEI BIOCAUSE HEILEN...
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    35370
    N/A
    2020-11-09
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    DEXMEDETOMIDINE DRUG SUBSTANCE

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    HUBEI BIOCAUSE HEILEN...
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    35455
    N/A
    2021-08-23
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    Fludarabine Phosphate Drug Substanc...

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    HUBEI BIOCAUSE HEILEN...
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    21047
    N/A
    2007-11-12
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    FLUDARABINE PHOSPHATE DRUG SUBSTANC...

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    HUBEI BIOCAUSE HEILEN...
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    34509
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    2023-01-17
    2022-10-29
    2020-04-29
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    FLUMAZENIL

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    HUBEI BIOCAUSE HEILEN...
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    19723
    N/A
    2006-08-31
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    GRANISETRON HYDROCHLORIDE, NON-STER...

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    HUBEI BIOCAUSE HEILEN...
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    19078
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    2005-12-15
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    HOMATROPINE HYDROBROMIDE

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    HUBEI BIOCAUSE HEILEN...
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    34161
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    2019-09-29
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    HOMATROPINE METHYLBROMIDE

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    HUBEI BIOCAUSE HEILEN...
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    28530
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    2015-12-23
    2015-02-19
    2014-07-28
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