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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by F. Hoffmann-la Roche to the Review Authority in Korea.

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    01 Erlotinib hydrochloride (1)

    02 Flumazenil (1)

    03 Ketorolactromethamine salt (1)

    04 Naphtopidil (1)

    05 Oseltamivir Phosphate (1)

    06 Sodium ibandronate (3)

    07 granisetron (1)

    08 nicorandil (1)

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    01 Alvogen Korea Co., Ltd. (1)

    02 Chong Kun Dang Co., Ltd. (1)

    03 Donga ST Co., Ltd. (1)

    04 GP Therapeutics Korea Co., Ltd. (1)

    05 Handok Co., Ltd. (1)

    06 JW Pharmaceutical Co., Ltd. (1)

    07 Jeil Pharmaceutical Co., Ltd. (1)

    08 Korea Roche Co., Ltd. (2)

    09 Meditip Co., Ltd. (1)

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    01 Chugai Pharma Manufacturing Co., Ltd (1)

    02 F. Hoffmann-La Roche AG (1)

    03 F. Hoffmann-La Roche Ltd (2)

    04 F. Hoffmann-La Roche Ltd. (1)

    05 F. Hoffmann-La Roche Ltd.@Micro-Macinazione SA (1)

    06 F. Hoffmann-La Roche Ltd.@Micro-Macinazione SA_x000D_ (1)

    07 Roche Diagnostics GmbH (2)

    08 Roche Ireland, Ltd. (1)

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    01 Germany (2)

    02 Ireland (1)

    03 Japan (1)

    04 Switzerland (6)

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    Erlotinib hydrochloride

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    Korea Roche Co., Ltd.
    2005-07-28
    Number 184-2-ND
    F. Hoffmann-La Roche Ltd
    Switzerland
    Grenzacherstrasse 124 CH-...
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    Flumazenil

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    Chong Kun Dang Co., Ltd.
    2005-08-31
    20050831-73-A-143-02
    F. Hoffmann-La Roche Ltd
    Switzerland
    Grenzacherstrasse 124 CH-...
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    granisetron

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    GP Therapeutics Korea Co., Ltd.
    2013-03-22
    20130322-177-I-144-04
    F. Hoffmann-La Roche Ltd.
    Switzerland
    Grenzacherstrasse 124 CH-...
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    Ketorolactromethamine salt

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    Meditip Co., Ltd.
    2005-08-31
    20050831-61-C-186-02
    Roche Ireland, Ltd.
    Ireland
    Clarecastle County Clare ...
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      Naphtopidil

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      Donga ST Co., Ltd.
      2011-04-29
      15-3-ND
      Roche Diagnostics GmbH
      Germany
      Sandhofer Strasse 116 D-6...
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        nicorandil

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        JW Pharmaceutical Co., Ltd.
        2021-08-03
        20210803-209-J-1084
        Chugai Pharma Manufacturi...
        Japan
        Fujieda Plant, 2500 Takay...
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        Oseltamivir Phosphate

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        Korea Roche Co., Ltd.
        2022-04-22
        20220422-209-J-1274
        F. Hoffmann-La Roche AG
        Switzerland
        Grenzacherstrasse 124, 40...
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        Sodium ibandronate

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        Alvogen Korea Co., Ltd.
        2013-07-12
        Number 184-3-ND(1)
        F. Hoffmann-La Roche Ltd....
        Switzerland
        Grenzacherstrasse 124 CH-...
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        Sodium ibandronate

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        Jeil Pharmaceutical Co., Ltd.
        2013-03-13
        Number 184-3-ND
        F. Hoffmann-La Roche Ltd....
        Switzerland
        Grenzacherstrasse 124 CH-...
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          Sodium ibandronate

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          Handok Co., Ltd.
          2005-07-28
          Number 184-1-ND
          Roche Diagnostics GmbH
          Germany
          Sandhofer Str. 116 D-6830...
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