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

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    OTSUKA CHEMICAL CO LTD

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    Otsuka Chemical Co Ltd
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    Country
    Country
    Japan
    Address
    Address
    3-2-27, Ote-Dori, Chuo-Ku, Osaka, 540-0021
    Telephone
    Telephone
    +81-6-6943-7701, +81 352 972 727
    Client Email
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    enquiries@pharmacompass.com
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    Website
    https://www.otsukac.co.jp:443/
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      CARTEOLOL HCL

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