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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Nippon Kayaku

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    Nippon Kayaku
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    Country
    Country
    Japan
    Address
    Address
    Meiji Yasuda Seimei Building 19th and 20th Floors, 1-1
    Telephone
    Telephone
    81-3-6731-5200
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    Email
    enquiries@pharmacompass.com
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    https://www.nipponkayaku.co.jp/english/
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      Etoposide

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      USDMF

      Found USDMF

      8946
      Active
      ETOPOSIDE
      1991-01-22
      CEP/COS

      Found CEP/COS

      R1-CEP 2004-003 - Rev 03
      Valid
      Etoposide
      2015-08-12
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      8946
      R1-CEP 2004-003 - Rev 03
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      ETOPOSIDE
      Etoposide
      Issue/Submission Date
      1991-01-22
      2015-08-12
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        Bleomycin

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        CEP 2002-149 - Rev 05
        Valid
        Bleomycin Sulfate
        2023-12-12
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        CEP 2002-149 - Rev 05
        Status
        Valid
         
        Filing Details
        Bleomycin Sulfate
        Issue/Submission Date
        2023-12-12
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          Bortezomib

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          USDMF

          Close USDMF

          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          230MF10025
          Bortezomib \"NK\" at 2-1-1 Marunouc...
          2018-02-15
          Written Confirmation

          Close WC

          Application Number
          230MF10025
          Status
           
          Filing Details
          Bortezomib \"NK\" at 2-1-1 Marunouc...
          Issue/Submission Date
          2018-02-15
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            Colistimethate Sodium

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            USDMF

            Close USDMF

            CEP/COS

            Close CEP/COS

            Japanese DMF

            Found JDMF

            217MF10573
            Colistin sodium methanesulfonate (p...
            2005-09-09
            Written Confirmation

            Close WC

            Application Number
            217MF10573
            Status
             
            Filing Details
            Colistin sodium methanesulfonate (p...
            Issue/Submission Date
            2005-09-09
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              Etoposide Phosphate

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              USDMF

              Found USDMF

              10476
              Active
              ETOPOSIDE PHOSPHATE
              1993-09-17
              CEP/COS

              Close CEP/COS

              Japanese DMF

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              Written Confirmation

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              Application Number
              10476
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              ETOPOSIDE PHOSPHATE
              Issue/Submission Date
              1993-09-17
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                Minocycline Hydrochloride

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                USDMF

                Caution USDMF

                13748
                Inactive
                MINOCYCLINE HYDROCHLORIDE
                1998-09-01
                CEP/COS

                Caution CEP/COS

                R0-CEP 1999-072 - Rev 02
                Withdrawn by Holder
                Minocycline hydrochloride dihydrate
                2004-08-20
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                13748
                R0-CEP 1999-072 - Rev 02
                Status
                Inactive
                Fees Unpaid
                N/A
                Withdrawn by Holder
                 
                Filing Details
                MINOCYCLINE HYDROCHLORIDE
                Minocycline hydrochloride dihydrate
                Issue/Submission Date
                1998-09-01
                2004-08-20
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                  Pemetrexed Disodium

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                  USDMF

                  Close USDMF

                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Found JDMF

                  227MF10038
                  Pemetrexed sodium hemi-pentahydrate...
                  2015-02-09
                  Written Confirmation

                  Close WC

                  Application Number
                  227MF10038
                  Status
                   
                  Filing Details
                  Pemetrexed sodium hemi-pentahydrate...
                  Issue/Submission Date
                  2015-02-09
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                    ubenimex

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                    USDMF

                    Found USDMF

                    29536
                    Active
                    UBENIMEX
                    2015-07-31
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    29536
                    Status
                    Active
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    UBENIMEX
                    Issue/Submission Date
                    2015-07-31
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                      Voglibose

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                      USDMF

                      Close USDMF

                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Found JDMF

                      218MF10189
                      Voglibose \"NK\" at 2-1-1 Marunouch...
                      2006-02-08
                      Written Confirmation

                      Close WC

                      Application Number
                      218MF10189
                      Status
                       
                      Filing Details
                      Voglibose \"NK\" at 2-1-1 Marunouch...
                      Issue/Submission Date
                      2006-02-08
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                        Zoledronic Acid

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                        USDMF

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                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Found JDMF

                        225MF10012
                        Zoledronic acid hydrate \"NK\" at 2...
                        2013-01-30
                        Written Confirmation

                        Close WC

                        Application Number
                        225MF10012
                        Status
                         
                        Filing Details
                        Zoledronic acid hydrate \"NK\" at 2...
                        Issue/Submission Date
                        2013-01-30
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                          Ambotzbaa1319

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                          USDMF

                          Caution USDMF

                          9814
                          Inactive
                          BOC-AHPBA-OH, INTERMEDIATE OF DRUG ...
                          1992-08-10
                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          9814
                          Status
                          Inactive
                          Fees Unpaid
                          N/A
                           
                          Filing Details
                          BOC-AHPBA-OH, INTERMEDIATE OF DRUG ...
                          Issue/Submission Date
                          1992-08-10
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                            Amino Acids Mixture

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                            USDMF

                            Caution USDMF

                            6062
                            Inactive
                            AMINO ACID
                            1985-09-25
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            6062
                            Status
                            Inactive
                            Fees Unpaid
                            N/A
                             
                            Filing Details
                            AMINO ACID
                            Issue/Submission Date
                            1985-09-25
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                              Aureobasidin E

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                              USDMF

                              Caution USDMF

                              9875
                              Inactive
                              AUREOBASIDIN A
                              1992-09-24
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              9875
                              Status
                              Inactive
                              Fees Unpaid
                              N/A
                               
                              Filing Details
                              AUREOBASIDIN A
                              Issue/Submission Date
                              1992-09-24
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                                Carbidopa

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                                USDMF

                                Caution USDMF

                                7063
                                Inactive
                                CARBIDOPA
                                1987-06-22
                                CEP/COS

                                Close CEP/COS

                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                7063
                                Status
                                Inactive
                                Fees Unpaid
                                N/A
                                 
                                Filing Details
                                CARBIDOPA
                                Issue/Submission Date
                                1987-06-22
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                                  Griseofulvin

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                                  USDMF

                                  Caution USDMF

                                  13582
                                  Inactive
                                  GRISEOFULVIN
                                  1998-09-01
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  13582
                                  Status
                                  Inactive
                                  Fees Unpaid
                                  N/A
                                   
                                  Filing Details
                                  GRISEOFULVIN
                                  Issue/Submission Date
                                  1998-09-01
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                                    Gusperimus

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                                    USDMF

                                    Caution USDMF

                                    6533
                                    Inactive
                                    DEOXYSPERGUALIN HYDROCHLORIDE FOR I...
                                    1986-08-12
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    6533
                                    Status
                                    Inactive
                                    Fees Unpaid
                                    N/A
                                     
                                    Filing Details
                                    DEOXYSPERGUALIN HYDROCHLORIDE FOR I...
                                    Issue/Submission Date
                                    1986-08-12
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                                      Gusperimus

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                                      USDMF

                                      Caution USDMF

                                      6537
                                      Inactive
                                      DEOXYSPERGUALIN HYDROCHLORIDE
                                      1986-08-12
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      6537
                                      Status
                                      Inactive
                                      Fees Unpaid
                                      N/A
                                       
                                      Filing Details
                                      DEOXYSPERGUALIN HYDROCHLORIDE
                                      Issue/Submission Date
                                      1986-08-12
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                                        Isoleucine

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                                        USDMF

                                        Caution USDMF

                                        4822
                                        Inactive
                                        L-THREONINE, L-TRYTOPHAN & L-ISOLEU...
                                        1982-12-20
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        4822
                                        Status
                                        Inactive
                                        Fees Unpaid
                                        N/A
                                         
                                        Filing Details
                                        L-THREONINE, L-TRYTOPHAN & L-ISOLEU...
                                        Issue/Submission Date
                                        1982-12-20
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                                          L-Alanine API

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                                          USDMF

                                          Caution USDMF

                                          4814
                                          Inactive
                                          L-ALANINE, L-METHIONINE & GLYCINE
                                          1982-12-20
                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

                                          Close WC

                                          Application Number
                                          4814
                                          Status
                                          Inactive
                                          Fees Unpaid
                                          N/A
                                           
                                          Filing Details
                                          L-ALANINE, L-METHIONINE & GLYCINE
                                          Issue/Submission Date
                                          1982-12-20
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                                            Methyldopa

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                                            USDMF

                                            Caution USDMF

                                            6124
                                            Inactive
                                            L-~-METHYLDOPA
                                            1986-01-08
                                            CEP/COS

                                            Close CEP/COS

                                            Japanese DMF

                                            Close JDMF

                                            Written Confirmation

                                            Close WC

                                            Application Number
                                            6124
                                            Status
                                            Inactive
                                            Fees Unpaid
                                            N/A
                                             
                                            Filing Details
                                            L-~-METHYLDOPA
                                            Issue/Submission Date
                                            1986-01-08
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                                              Sucralfate

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                                              USDMF

                                              Caution USDMF

                                              6048
                                              Inactive
                                              SUCRALFATE
                                              1985-09-27
                                              CEP/COS

                                              Close CEP/COS

                                              Japanese DMF

                                              Close JDMF

                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              6048
                                              Status
                                              Inactive
                                              Fees Unpaid
                                              N/A
                                               
                                              Filing Details
                                              SUCRALFATE
                                              Issue/Submission Date
                                              1985-09-27
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                                                Sulindac

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                                                USDMF

                                                Caution USDMF

                                                7064
                                                Inactive
                                                SULINDAC
                                                1987-06-22
                                                CEP/COS

                                                Close CEP/COS

                                                Japanese DMF

                                                Close JDMF

                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                7064
                                                Status
                                                Inactive
                                                Fees Unpaid
                                                N/A
                                                 
                                                Filing Details
                                                SULINDAC
                                                Issue/Submission Date
                                                1987-06-22
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                                                  BUTADIAMUPLATIN

                                                  PDF Supplier PDF
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                                                  USDMF

                                                  Caution USDMF

                                                  7331
                                                  Inactive
                                                  BUTADIAMUPLATIN
                                                  1988-01-20
                                                  CEP/COS

                                                  Close CEP/COS

                                                  Japanese DMF

                                                  Close JDMF

                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  7331
                                                  Status
                                                  Inactive
                                                  Fees Unpaid
                                                  N/A
                                                   
                                                  Filing Details
                                                  BUTADIAMUPLATIN
                                                  Issue/Submission Date
                                                  1988-01-20
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                                                    UBINIMEX

                                                    PDF Supplier PDF
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                                                    USDMF

                                                    Caution USDMF

                                                    10042
                                                    Inactive
                                                    UBINIMEX
                                                    1993-01-22
                                                    CEP/COS

                                                    Close CEP/COS

                                                    Japanese DMF

                                                    Close JDMF

                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    10042
                                                    Status
                                                    Inactive
                                                    Fees Unpaid
                                                    N/A
                                                     
                                                    Filing Details
                                                    UBINIMEX
                                                    Issue/Submission Date
                                                    1993-01-22
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