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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Otsuka Holdings to the U.S. FDA. Original Data : FDA Website

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    APIs // Active Pharmaceutical Ingredients

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    Otsuka Holdings
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    Country
    Country
    Japan
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    2-9 Kanda-Tsukasamachi, Chiyoda-ku, Tokyo 101-0048
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    +81 (0)3-6717-1410
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    enquiries@pharmacompass.com
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    https://www.otsuka.com/en/
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      CARTEOLOL HCL

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      OTSUKA PHARMACEUTICAL...
      Inactive
      2671
      N/A
      1976-05-13
      II
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        CDHP

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        TAIHO PHARMACEUTICAL ...
        Inactive
        12554
        N/A
        1997-06-18
        II
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        DIINDOLYLMETHANE DRUG SUBSTANCE

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        INTERPHARMA PRAHA AS
        Active
        16998
        N/A
        2003-12-01
        II
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          FTORAFUR (ALSO CALLED FUTRAFUL OR T...

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          TAIHO PHARMACEUTICAL ...
          Inactive
          4235
          N/A
          1981-08-05
          II
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            GTS-21

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            TAIHO PHARMACEUTICAL ...
            Inactive
            14645
            N/A
            1999-12-28
            II
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            IODIPAMIDE DRUG SUBSTANCE

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            INTERPHARMA PRAHA AS
            Inactive
            10576
            N/A
            1993-11-18
            II
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            IOHEXOL DRUG SUBSTANCE, FOR ORAL PR...

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            INTERPHARMA PRAHA AS
            Inactive
            26641
            N/A
            2013-01-24
            II
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              IPD-1151T DRUG SUBSTANCE

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              TAIHO PHARMACEUTICAL ...
              Inactive
              17336
              N/A
              2004-04-12
              II
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                NADIFLOXACIN DRUG SUBSTANCE

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                OTSUKA PHARMACEUTICAL...
                Inactive
                12418
                N/A
                1997-03-01
                II
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                  NO-1886 DRUG SUBSTANCE

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                  OTSUKA PHARMACEUTICAL...
                  Inactive
                  13285
                  N/A
                  1998-10-15
                  II
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                  OPA-15406 DRUG SUBSTANCE

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                  OTSUKA PHARMACEUTICAL...
                  Active
                  30529
                  N/A
                  2016-05-23
                  II
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                    P-METHOXYBENZYL (6R,7R)-3-CHLOROMET...

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                    OTSUKA CHEMICAL INDIA...
                    Active
                    22722
                    N/A
                    2009-04-13
                    II
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                      P-METHOXYBENZYL(6R,7R)-3-CHLOROMETH...

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                      OTSUKA CHEMICAL CO LT...
                      Inactive
                      20451
                      N/A
                      2007-04-10
                      II
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                        PROCATEROL HYDROCHLORIDE HEMIHYDRAT...

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                        OTSUKA PHARMACEUTICAL...
                        Inactive
                        3606
                        N/A
                        1979-09-19
                        II
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                          PROCATEROL, AEROSOL FORMULATION PRO...

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                          OTSUKA PHARMACEUTICAL...
                          Inactive
                          4820
                          N/A
                          1983-01-17
                          II
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                            REBAMIPIDE(OPC-12759) DRUG SUBSTANC...

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                            OTSUKA PHARMACEUTICAL...
                            Inactive
                            15001
                            N/A
                            2000-08-10
                            II
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                              STERILE WATER FOR INJECTION USP, 2 ...

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                              OTSUKA AMERICA PHARMA...
                              Inactive
                              25240
                              N/A
                              2011-09-19
                              II
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                                TAC-101 DRUG SUBSTANCE

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                                TAIHO PHARMACEUTICAL ...
                                Inactive
                                21314
                                N/A
                                2008-02-06
                                II
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                                  TAZOBACTAM

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                                  OTSUKA CHEMICAL CO LT...
                                  Active
                                  31398
                                  Complete
                                  2018-03-20
                                  2017-08-28
                                  2017-08-30
                                  II
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                                    TEGAFUR

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                                    TAIHO PHARMACEUTICAL ...
                                    Inactive
                                    10396
                                    N/A
                                    1993-06-17
                                    II
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                                      TIPIRACIL HYDROCHLORIDE (TPI)

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                                      TAIHO PHARMACEUTICAL ...
                                      Active
                                      28368
                                      N/A
                                      2014-11-25
                                      II
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                                        TRIFLURIDINE DRUG SUBSTANCE

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                                        TAIHO PHARMACEUTICAL ...
                                        Active
                                        34596
                                        N/A
                                        2020-03-16
                                        II
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                                        Trospium Chloride

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                                        INTERPHARMA PRAHA AS
                                        Inactive
                                        21171
                                        N/A
                                        2007-10-10
                                        II
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                                          UFT CAPSULES (TEGAFUR AND URACIL)

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                                          TAIHO PHARMACEUTICAL ...
                                          Inactive
                                          10400
                                          N/A
                                          1993-06-17
                                          II
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                                            COMMERCIAL BULK PLANT OF SECOND TOK...

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                                            OTSUKA PHARMACEUTICAL...
                                            Inactive
                                            9896
                                            N/A
                                            1992-10-05
                                            II
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                                              FACILITIES AND OPERATING PROCEDURES...

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                                              OTSUKA PHARMACEUTICAL...
                                              Inactive
                                              9894
                                              N/A
                                              1992-08-21
                                              II
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                                                FORMULATION RESEARCH INSTITUTE IN T...

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                                                OTSUKA PHARMACEUTICAL...
                                                Inactive
                                                10257
                                                N/A
                                                1993-05-20
                                                II
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                                                  MANUFACTURING SITE, FACILITIES, PER...

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                                                  OTSUKA PHARMACEUTICAL...
                                                  Inactive
                                                  6085
                                                  N/A
                                                  1985-11-07
                                                  II
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                                                    MANUFACTURING SITE, FACILITIES, PER...

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                                                    OTSUKA PHARMACEUTICAL...
                                                    Inactive
                                                    6091
                                                    N/A
                                                    1985-11-07
                                                    II
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                                                      MANUFACTURING SITE, FACILITIES, PER...

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                                                      OTSUKA PHARMACEUTICAL...
                                                      Inactive
                                                      9534
                                                      N/A
                                                      1992-01-10
                                                      II
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                                                        TAS-103

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                                                        TAIHO PHARMACEUTICAL ...
                                                        Inactive
                                                        11983
                                                        N/A
                                                        1996-05-31
                                                        II
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                                                          WM-1-DAITO INTERMEDIATE FOR CDHP

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                                                          TAIHO PHARMACEUTICAL ...
                                                          Inactive
                                                          20637
                                                          N/A
                                                          2007-06-27
                                                          II
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