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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Otsuka Holdings to the Review Authority in Korea.

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    01 Aripiprazole (1)

    02 Aripiprazole monohydrate (1)

    03 Tipiracil hydrochloride (1)

    04 Tolvaptan SD powder (1)

    05 gimerasil (1)

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    01 Jeil Pharmaceutical Co., Ltd. (1)

    02 Korea Otsuka Pharmaceutical Co., Ltd. (3)

    03 Sinex Co., Ltd. (1)

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    01 Otsuka Pharmaceutical Co., Ltd (Tolvaptan Spray Dried Powder Manufacturer)@Otsuka Pharmaceutical Co., Ltd (Tolvaptan Manufacturer) (1)

    02 Otsuka Pharmaceutical Co., Ltd. Saga Factory (1)

    03 Otsuka Pharmaceutical Co., Ltd. Second Tokushima Factory@Otsuka Pharmaceutical Co., Ltd. Saga Factory (1)

    04 Taiho Pharmaceutical Co., Ltd Saitama Factory (1)

    05 Taiho Pharmaceutical Co., Ltd. Saitama Plant (1)

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    01 Japan (5)

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      Aripiprazole

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      Korea Otsuka Pharmaceutical Co., Ltd.
      2021-03-16
      20210316-209-J-877
      Otsuka Pharmaceutical Co....
      Japan
      5006-5 Aza Higashiyama, O...
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      Aripiprazole monohydrate

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      Korea Otsuka Pharmaceutical Co., Ltd.
      2022-11-25
      20221125-209-J-1414
      Otsuka Pharmaceutical Co....
      Japan
      224-18 Hiraishi Ebisuno, ...
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        gimerasil

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        Jeil Pharmaceutical Co., Ltd.
        2003-07-22
        21-1-ND
        Taiho Pharmaceutical Co.,...
        Japan
        200-22, Motohara, Kamikaw...
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          Tipiracil hydrochloride

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          Sinex Co., Ltd.
          2018-12-26
          Number 487-2-ND
          Taiho Pharmaceutical Co.,...
          Japan
          200-22 Motohara, Kamikawa...
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            Tolvaptan SD powder

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            Korea Otsuka Pharmaceutical Co., Ltd.
            2013-04-26
            Number 1633-3-ND
            Otsuka Pharmaceutical Co....
            Japan
            463-10, kagasuno, Kawauch...
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