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

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    01 Azelnidipine (1)

    02 Bortezomib (2)

    03 Bosentan Hydrate (1)

    04 Caffeine (1)

    05 Dobutamine Hydrochloride (1)

    06 Dotinurad (1)

    07 Emedastine Fumarate (1)

    08 Gimeracil-13C3 (1)

    09 Methylprednisolone Sodium Succinate (1)

    10 Nemonapride (1)

    11 Noscapine (1)

    12 Noscapine Hydrochloride (1)

    13 Olanzapine (1)

    14 Oteracil Potassium (1)

    15 Palonosetron (1)

    16 Pilsicainide Hydrochloride (1)

    17 Pimobendan (1)

    18 Sapropterin Hydrochloride (1)

    19 Solifenacin Succinate (1)

    20 Theophylline (1)

    21 Tolvaptan (1)

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    01 Active (1)

    02 Inactive (1)

    03 Blank (20)

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    01 Blank (22)

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    01 217MF10314 (1)

    02 217MF10315 (1)

    03 217MF10316 (1)

    04 217MF10317 (1)

    05 217MF10318 (1)

    06 217MF10321 (1)

    07 217MF10323 (1)

    08 218MF10997 (1)

    09 224MF10037 (1)

    10 224MF10038 (1)

    11 225MF10004 (1)

    12 225MF10134 (1)

    13 227MF10046 (1)

    14 227MF10189 (1)

    15 229MF10148 (1)

    16 230MF10017 (1)

    17 230MF10137 (1)

    18 301MF10086 (1)

    19 301MF10095 (1)

    20 302MF10012 (1)

    21 302MF10134 (1)

    22 Blank (1)

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    01 Blank (22)

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      Emedastine Fumarate

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      USDMF

      Found USDMF

      11759
      Active
      EMEDASTINE DIFUMARATE
      1995-11-29
      CEP/COS

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      Japanese DMF

      Found JDMF

      230MF10017
      Japanese Pharmacopoeia fumaric acid...
      2018-02-05
      Written Confirmation

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      Application Number
      11759
      230MF10017
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      EMEDASTINE DIFUMARATE
      Japanese Pharmacopoeia fumaric acid...
      Issue/Submission Date
      1995-11-29
      2018-02-05
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        Azelnidipine

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        USDMF

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        CEP/COS

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        Japanese DMF

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        224MF10038
        Azelnidipine production dedicated a...
        2012-02-23
        Written Confirmation

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        Application Number
        224MF10038
        Status
         
        Filing Details
        Azelnidipine production dedicated a...
        Issue/Submission Date
        2012-02-23
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          Bortezomib

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          USDMF

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          CEP/COS

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          301MF10086
          Bortezomib production only at 6-11-...
          2019-10-29
          Written Confirmation

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          Application Number
          301MF10086
          Status
           
          Filing Details
          Bortezomib production only at 6-11-...
          Issue/Submission Date
          2019-10-29
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            Bortezomib

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            USDMF

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            Japanese DMF

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            229MF10148
            Bortezomib production dedicated at ...
            2017-07-31
            Written Confirmation

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            Application Number
            229MF10148
            Status
             
            Filing Details
            Bortezomib production dedicated at ...
            Issue/Submission Date
            2017-07-31
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              Bosentan Hydrate

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              USDMF

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              CEP/COS

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              Japanese DMF

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              227MF10189
              Bosentan hydrate production-only at...
              2015-08-03
              Written Confirmation

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              Application Number
              227MF10189
              Status
               
              Filing Details
              Bosentan hydrate production-only at...
              Issue/Submission Date
              2015-08-03
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                Caffeine

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                USDMF

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                CEP/COS

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                Japanese DMF

                Found JDMF

                217MF10314
                Only the Japanese Pharmacopoeia anh...
                2005-07-14
                Written Confirmation

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                Application Number
                217MF10314
                Status
                 
                Filing Details
                Only the Japanese Pharmacopoeia anh...
                Issue/Submission Date
                2005-07-14
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                  Dobutamine Hydrochloride

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                  USDMF

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                  CEP/COS

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                  Japanese DMF

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                  217MF10318
                  Japanese Pharmacopoeia hydrochloric...
                  2005-07-14
                  Written Confirmation

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                  Application Number
                  217MF10318
                  Status
                   
                  Filing Details
                  Japanese Pharmacopoeia hydrochloric...
                  Issue/Submission Date
                  2005-07-14
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                    Dotinurad

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                    USDMF

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                    CEP/COS

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                    Japanese DMF

                    Found JDMF

                    230MF10137
                    Dochinrad manufacturing only at 6-1...
                    2018-10-01
                    Written Confirmation

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                    Application Number
                    230MF10137
                    Status
                     
                    Filing Details
                    Dochinrad manufacturing only at 6-1...
                    Issue/Submission Date
                    2018-10-01
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                      Gimeracil-13C3

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                      USDMF

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                      CEP/COS

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                      Japanese DMF

                      Found JDMF

                      224MF10037
                      Gimeracil production dedicated at 6...
                      2012-02-23
                      Written Confirmation

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                      Application Number
                      224MF10037
                      Status
                       
                      Filing Details
                      Gimeracil production dedicated at 6...
                      Issue/Submission Date
                      2012-02-23
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                        Methylprednisolone Sodium Succinate

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                        USDMF

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                        CEP/COS

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                        Japanese DMF

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                        217MF10323
                        Methylprednisolone sodium succinate...
                        2005-07-14
                        Written Confirmation

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                        Application Number
                        217MF10323
                        Status
                         
                        Filing Details
                        Methylprednisolone sodium succinate...
                        Issue/Submission Date
                        2005-07-14
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