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    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Ouchi Shinko Chemical Industrial to the Review Authority in Japan (PMDA). Original Data : PMDA

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    01 Candesartan cilexetil (production only) (1)

    02 Cilostazol (production only) (1)

    03 Epalrestat (production only) (1)

    04 Hydrochloric acid arotinolol (production only) (1)

    05 Istradefylline (manufacturing only) (1)

    06 Japanese Pharmacopoeia Epalrestat (manufacturing only) (1)

    07 Japanese Pharmacopoeia bunazosin hydrochloride (production only) (1)

    08 Propiverine hydrochloride (production only) (1)

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    01 Ouchi Shinko Chemical Industry Co., Ltd. (8)

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    01 Japan (8)

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      Candesartan cilexetil (production only)

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      Ouchi Shinko Chemical Ind...
      2013-07-25
      2013-07-25
      225MF10143
      7-4 Kobune-cho, Nihonbash...
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        Cilostazol (production only)

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        Ouchi Shinko Chemical Ind...
        2008-06-10
        2005-10-07
        217MF10696
        7-4 Kobune-cho, Nihonbash...
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          Epalrestat (production only)

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          Ouchi Shinko Chemical Ind...
          2008-02-25
          2005-10-07
          217MF10698
          7-4 Kobune-cho, Nihonbash...
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            Hydrochloric acid arotinolol (production only)

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            Ouchi Shinko Chemical Ind...
            2008-04-11
            2005-10-07
            217MF10695
            7-4 Kobune-cho, Nihonbash...
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              Istradefylline (manufacturing only)

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              Ouchi Shinko Chemical Ind...
              2022-05-12
              2021-07-16
              303MF10109
              7-4 Kobune-cho, Nihonbash...
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                Japanese Pharmacopoeia bunazosin hydrochloride (product...

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                Ouchi Shinko Chemical Ind...
                2013-04-18
                2013-04-18
                225MF10068
                7-4 Kobune-cho, Nihonbash...
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                  Japanese Pharmacopoeia Epalrestat (manufacturing only)

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                  Ouchi Shinko Chemical Ind...
                  2019-06-07
                  2019-06-07
                  301MF10017
                  7-4 Kobune-cho, Nihonbash...
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                    Propiverine hydrochloride (production only)

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                    Ouchi Shinko Chemical Ind...
                    2007-06-08
                    2005-10-07
                    217MF10697
                    7-4 Kobune-cho, Nihonbash...
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