Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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

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    Shiratori Pharmaceutical
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    Country
    Country
    Japan
    Address
    Address
    2-3-7, Akanehama Narashino, 275-0024
    Telephone
    Telephone
    81(43)307-8977
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://shiratori-pharm.co.jp/en/
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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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        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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          CEP/COS

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          Japanese DMF

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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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            CEP/COS

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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

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                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

                  Close WC

                  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

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                      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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                          Nemonapride

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                          USDMF

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                          CEP/COS

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                          Japanese DMF

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                          225MF10134
                          Nemonapride production dedicated at...
                          2013-07-23
                          Written Confirmation

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                          Application Number
                          225MF10134
                          Status
                           
                          Filing Details
                          Nemonapride production dedicated at...
                          Issue/Submission Date
                          2013-07-23
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                            Noscapine

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                            USDMF

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                            CEP/COS

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                            Japanese DMF

                            Found JDMF

                            217MF10315
                            Only the Japanese Pharmacopoeia nos...
                            2005-07-14
                            Written Confirmation

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                            Application Number
                            217MF10315
                            Status
                             
                            Filing Details
                            Only the Japanese Pharmacopoeia nos...
                            Issue/Submission Date
                            2005-07-14
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                              Noscapine Hydrochloride

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                              USDMF

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                              CEP/COS

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                              Japanese DMF

                              Found JDMF

                              217MF10316
                              Japanese Pharmacopoeia hydrochloric...
                              2005-07-14
                              Written Confirmation

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                              Application Number
                              217MF10316
                              Status
                               
                              Filing Details
                              Japanese Pharmacopoeia hydrochloric...
                              Issue/Submission Date
                              2005-07-14
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                                Olanzapine

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                                USDMF

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                                CEP/COS

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                                Japanese DMF

                                Found JDMF

                                227MF10046
                                Olanzapine production dedicated at ...
                                2015-02-09
                                Written Confirmation

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                                Application Number
                                227MF10046
                                Status
                                 
                                Filing Details
                                Olanzapine production dedicated at ...
                                Issue/Submission Date
                                2015-02-09
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                                  Oteracil Potassium

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                                  USDMF

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                                  CEP/COS

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                                  Japanese DMF

                                  Found JDMF

                                  225MF10004
                                  Oteracil potassium production dedic...
                                  2013-01-18
                                  Written Confirmation

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                                  Application Number
                                  225MF10004
                                  Status
                                   
                                  Filing Details
                                  Oteracil potassium production dedic...
                                  Issue/Submission Date
                                  2013-01-18
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                                    Palonosetron

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                                    USDMF

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                                    CEP/COS

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                                    Japanese DMF

                                    Found JDMF

                                    302MF10012
                                    Dedicated to the production of palo...
                                    2020-01-24
                                    Written Confirmation

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                                    Application Number
                                    302MF10012
                                    Status
                                     
                                    Filing Details
                                    Dedicated to the production of palo...
                                    Issue/Submission Date
                                    2020-01-24
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                                      Pilsicainide Hydrochloride

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                                      USDMF

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                                      CEP/COS

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                                      Japanese DMF

                                      Found JDMF

                                      217MF10321
                                      Hydrochloric acid Pilsicainide at 6...
                                      2005-07-14
                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      217MF10321
                                      Status
                                       
                                      Filing Details
                                      Hydrochloric acid Pilsicainide at 6...
                                      Issue/Submission Date
                                      2005-07-14
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                                        Pimobendan

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                                        USDMF

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                                        CEP/COS

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                                        Japanese DMF

                                        Found JDMF

                                        218MF10997
                                        Pimobendan production dedicated at ...
                                        2006-12-18
                                        Written Confirmation

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                                        Application Number
                                        218MF10997
                                        Status
                                         
                                        Filing Details
                                        Pimobendan production dedicated at ...
                                        Issue/Submission Date
                                        2006-12-18
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                                          Solifenacin Succinate

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                                          USDMF

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                                          CEP/COS

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                                          Japanese DMF

                                          Found JDMF

                                          301MF10095
                                          Dedicated for manufacturing solifen...
                                          2019-11-19
                                          Written Confirmation

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                                          Application Number
                                          301MF10095
                                          Status
                                           
                                          Filing Details
                                          Dedicated for manufacturing solifen...
                                          Issue/Submission Date
                                          2019-11-19
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                                            Theophylline

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                                            USDMF

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                                            CEP/COS

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                                            Japanese DMF

                                            Found JDMF

                                            217MF10317
                                            Japanese Pharmacopoeia theophylline...
                                            2005-07-14
                                            Written Confirmation

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                                            Application Number
                                            217MF10317
                                            Status
                                             
                                            Filing Details
                                            Japanese Pharmacopoeia theophylline...
                                            Issue/Submission Date
                                            2005-07-14
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                                              Tolvaptan

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                                              USDMF

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                                              CEP/COS

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                                              Japanese DMF

                                              Found JDMF

                                              302MF10134
                                              Dedicated to tolvaptan production a...
                                              2020-11-04
                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              302MF10134
                                              Status
                                               
                                              Filing Details
                                              Dedicated to tolvaptan production a...
                                              Issue/Submission Date
                                              2020-11-04
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                                                Sapropterin Hydrochloride

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                                                USDMF

                                                Caution USDMF

                                                17569
                                                Inactive
                                                SAPROPTERIN HYDROCHLORIDE DRUG SUBS...
                                                2004-07-20
                                                CEP/COS

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                                                Japanese DMF

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                                                Written Confirmation

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                                                Application Number
                                                17569
                                                Status
                                                Inactive
                                                Fees Unpaid
                                                N/A
                                                 
                                                Filing Details
                                                SAPROPTERIN HYDROCHLORIDE DRUG SUBS...
                                                Issue/Submission Date
                                                2004-07-20
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