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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Brightgene Bio-medical Technology Co.,ltd to the Review Authority in Korea.

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    01 Anidulafungin (1)

    02 Caspofungin acetate (4)

    03 Entecavir (1)

    04 Entecavir monohydrate (micronized) (1)

    05 Sodium micafungin (1)

    06 Sugammadex Sodium (4)

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    01 Classia Co., Ltd. (1)

    02 ESEM International Co., Ltd. (2)

    03 Hana Pharmaceutical Co., Ltd. (1)

    04 Masung LS Co., Ltd. (1)

    05 Otran Farm Korea Co., Ltd. (6)

    06 Penmix Co., Ltd. (1)

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    01 BrightGene Pharmaceutical Co. Ltd. (6)

    02 BrightGene Pharmaceutical Co. Ltd.@BrightGene Fine Chemical Co., Ltd. (4)

    03 BrightGene Pharmaceutical Co. Ltd.@BrightGene Fine Chemical Co., Ltd.@BrightGene Fine Chemical Co., Ltd. (1)

    04 BrightGene Pharmaceutical Co., Ltd (1)

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    01 China (12)

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    Anidulafungin

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    Otran Farm Korea Co., Ltd.
    2019-11-11
    Number 695-2-ND
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Caspofungin acetate

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    Otran Farm Korea Co., Ltd.
    2019-05-13
    20190111-210-J-111(2)
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Caspofungin acetate

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    Classia Co., Ltd.
    2019-03-22
    20190111-210-J-111(1)
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Caspofungin acetate

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    ESEM International Co., Ltd.
    2020-01-09
    20190111-210-J-111(3)
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Caspofungin acetate

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    Penmix Co., Ltd.
    2019-01-11
    20190111-210-J-111
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Entecavir

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    Otran Farm Korea Co., Ltd.
    2017-09-12
    Wed21-4-ND
    BrightGene Pharmaceutical...
    China
    No. 218 Xinghu Road, Suzh...
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    Entecavir monohydrate (micronized)

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    Otran Farm Korea Co., Ltd.
    2022-05-30
    Number 695-7-ND
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Sodium micafungin

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    Otran Farm Korea Co., Ltd.
    2019-06-25
    Number 695-1-ND
    BrightGene Pharmaceutical...
    China
    Building C25-C28, No.218 ...
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    Sugammadex Sodium

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    Masung LS Co., Ltd.
    2022-12-22
    Number 695-5-ND(3)
    BrightGene Pharmaceutical...
    China
    No.218 Xinghu Road, Suzho...
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    Sugammadex Sodium

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    ESEM International Co., Ltd.
    2022-05-22
    Number 695-5-ND(2)
    BrightGene Pharmaceutical...
    China
    No.218 Xinghu Road, Suzho...
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