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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Osaka Synthetic Chemical Laboratories

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    Osaka Synthetic Chemical Laboratories
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    1-1-2　Nishinomiyahama, Nishinomiya-shi, Hyogo 662-0934
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      Alprazolam

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      USDMF

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      Japanese DMF

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      217MF10394
      Japanese Pharmacopoeia alprazolam p...
      2005-08-10
      Written Confirmation

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      Application Number
      217MF10394
      Status
       
      Filing Details
      Japanese Pharmacopoeia alprazolam p...
      Issue/Submission Date
      2005-08-10
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        Bepotastine

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        USDMF

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        Japanese DMF

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        229MF10016
        Japanese Pharmacopoeia bepotastine ...
        2017-01-25
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        Application Number
        229MF10016
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        Japanese Pharmacopoeia bepotastine ...
        Issue/Submission Date
        2017-01-25
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          Blonanserin

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          230MF10035
          Blonanserin production dedicated at...
          2018-02-26
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          Application Number
          230MF10035
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          Blonanserin production dedicated at...
          Issue/Submission Date
          2018-02-26
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            Bromperidol

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            305MF10052
            Bromperidol For manufacturing only ...
            2023-04-25
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            Application Number
            305MF10052
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            Bromperidol For manufacturing only ...
            Issue/Submission Date
            2023-04-25
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              Cerocral

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              USDMF

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              Japanese DMF

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              218MF10594
              Only the Japanese Pharmacopoeia ife...
              2006-06-22
              Written Confirmation

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              Application Number
              218MF10594
              Status
               
              Filing Details
              Only the Japanese Pharmacopoeia ife...
              Issue/Submission Date
              2006-06-22
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                Cilnidipine

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                USDMF

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                CEP/COS

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                Japanese DMF

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                225MF10006
                Cilnidipine production dedicated at...
                2013-01-18
                Written Confirmation

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                Application Number
                225MF10006
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                Filing Details
                Cilnidipine production dedicated at...
                Issue/Submission Date
                2013-01-18
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                  Ciprofloxacin

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                  CEP/COS

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                  Japanese DMF

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                  221MF10286
                  Japanese Pharmacopoeia toss ciprofl...
                  2009-12-22
                  Written Confirmation

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                  Application Number
                  221MF10286
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                  Filing Details
                  Japanese Pharmacopoeia toss ciprofl...
                  Issue/Submission Date
                  2009-12-22
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                    Ciprofloxacin

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                    Japanese DMF

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                    229MF10174
                    Japanese Pharmacopoeia toss ciprofl...
                    2017-09-04
                    Written Confirmation

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                    Application Number
                    229MF10174
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                    Filing Details
                    Japanese Pharmacopoeia toss ciprofl...
                    Issue/Submission Date
                    2017-09-04
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                      Clopidogrel

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                      USDMF

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                      CEP/COS

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                      Japanese DMF

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                      226MF10032
                      Clopidogrel salt production dedicat...
                      2014-02-05
                      Written Confirmation

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                      Application Number
                      226MF10032
                      Status
                       
                      Filing Details
                      Clopidogrel salt production dedicat...
                      Issue/Submission Date
                      2014-02-05
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                        Deferasirox

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                        USDMF

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                        CEP/COS

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                        Japanese DMF

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                        231MF10012
                        Deferasirox manufacturing only at 1...
                        2019-01-11
                        Written Confirmation

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                        Application Number
                        231MF10012
                        Status
                         
                        Filing Details
                        Deferasirox manufacturing only at 1...
                        Issue/Submission Date
                        2019-01-11
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                          DL-Tartaric acid

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                          USDMF

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                          CEP/COS

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                          Japanese DMF

                          Found JDMF

                          217MF10397
                          Japanese Pharmacopoeia tartaric aci...
                          2005-08-10
                          Written Confirmation

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                          Application Number
                          217MF10397
                          Status
                           
                          Filing Details
                          Japanese Pharmacopoeia tartaric aci...
                          Issue/Submission Date
                          2005-08-10
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                            Estazolam

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                            USDMF

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                            CEP/COS

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                            Japanese DMF

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                            217MF10395
                            Only the Japanese Pharmacopoeia est...
                            2005-08-10
                            Written Confirmation

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                            Application Number
                            217MF10395
                            Status
                             
                            Filing Details
                            Only the Japanese Pharmacopoeia est...
                            Issue/Submission Date
                            2005-08-10
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                              Etilefrine

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                              USDMF

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                              CEP/COS

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                              Japanese DMF

                              Found JDMF

                              305MF10005
                              Japanese Pharmacopoeia Etilefrine H...
                              2023-01-18
                              Written Confirmation

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                              Application Number
                              305MF10005
                              Status
                               
                              Filing Details
                              Japanese Pharmacopoeia Etilefrine H...
                              Issue/Submission Date
                              2023-01-18
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                                Ferric Citrate

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                                USDMF

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                                CEP/COS

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                                Japanese DMF

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                                228MF10016
                                Stand spiron citrate production ded...
                                2016-01-08
                                Written Confirmation

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                                Application Number
                                228MF10016
                                Status
                                 
                                Filing Details
                                Stand spiron citrate production ded...
                                Issue/Submission Date
                                2016-01-08
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                                  Fexofenadine Hydrochloride

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                                  USDMF

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                                  CEP/COS

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                                  Japanese DMF

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                                  230MF10064
                                  Japanese Pharmacopoeia fexofenadine...
                                  2018-05-08
                                  Written Confirmation

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                                  Application Number
                                  230MF10064
                                  Status
                                   
                                  Filing Details
                                  Japanese Pharmacopoeia fexofenadine...
                                  Issue/Submission Date
                                  2018-05-08
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                                    Fexofenadine Hydrochloride

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                                    USDMF

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                                    CEP/COS

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                                    Japanese DMF

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                                    223MF10072
                                    Japanese Pharmacopoeia fexofenadine...
                                    2011-05-27
                                    Written Confirmation

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                                    Application Number
                                    223MF10072
                                    Status
                                     
                                    Filing Details
                                    Japanese Pharmacopoeia fexofenadine...
                                    Issue/Submission Date
                                    2011-05-27
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                                      Imidapril Hydrochloride

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                                      USDMF

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                                      CEP/COS

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                                      Japanese DMF

                                      Found JDMF

                                      221MF10285
                                      Only the Japanese Pharmacopoeia imi...
                                      2009-12-22
                                      Written Confirmation

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                                      Application Number
                                      221MF10285
                                      Status
                                       
                                      Filing Details
                                      Only the Japanese Pharmacopoeia imi...
                                      Issue/Submission Date
                                      2009-12-22
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                                        Lafutidine

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                                        USDMF

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                                        CEP/COS

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                                        Japanese DMF

                                        Found JDMF

                                        224MF10237
                                        Only the Japanese Pharmacopoeia Laf...
                                        2012-12-20
                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        224MF10237
                                        Status
                                         
                                        Filing Details
                                        Only the Japanese Pharmacopoeia Laf...
                                        Issue/Submission Date
                                        2012-12-20
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                                          Minodronic Acid

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                                          USDMF

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                                          CEP/COS

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                                          Japanese DMF

                                          Found JDMF

                                          229MF10049
                                          Minodronic acid hydrate production-...
                                          2017-02-22
                                          Written Confirmation

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                                          Application Number
                                          229MF10049
                                          Status
                                           
                                          Filing Details
                                          Minodronic acid hydrate production-...
                                          Issue/Submission Date
                                          2017-02-22
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                                            Mosapride Citrate

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                                            USDMF

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                                            CEP/COS

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                                            Japanese DMF

                                            Found JDMF

                                            223MF10097
                                            Japanese Pharmacopoeia mosapride ac...
                                            2011-07-06
                                            Written Confirmation

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                                            Application Number
                                            223MF10097
                                            Status
                                             
                                            Filing Details
                                            Japanese Pharmacopoeia mosapride ac...
                                            Issue/Submission Date
                                            2011-07-06
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                                              Nalfurafine

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                                              USDMF

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                                              CEP/COS

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                                              Japanese DMF

                                              Found JDMF

                                              305MF10059
                                              Nalfurafine Hydrochloride For Manuf...
                                              2023-05-10
                                              Written Confirmation

                                              Close WC

                                              Application Number
                                              305MF10059
                                              Status
                                               
                                              Filing Details
                                              Nalfurafine Hydrochloride For Manuf...
                                              Issue/Submission Date
                                              2023-05-10
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                                                Nalfurafine

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                                                USDMF

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                                                CEP/COS

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                                                Japanese DMF

                                                Found JDMF

                                                229MF10043
                                                Nalfurafine hydrochloride salt prod...
                                                2017-02-20
                                                Written Confirmation

                                                Close WC

                                                Application Number
                                                229MF10043
                                                Status
                                                 
                                                Filing Details
                                                Nalfurafine hydrochloride salt prod...
                                                Issue/Submission Date
                                                2017-02-20
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                                                  Paroxetine Hydrochloride

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                                                  USDMF

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                                                  CEP/COS

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                                                  Japanese DMF

                                                  Found JDMF

                                                  227MF10216
                                                  Only the Japanese Pharmacopoeia par...
                                                  2015-08-31
                                                  Written Confirmation

                                                  Close WC

                                                  Application Number
                                                  227MF10216
                                                  Status
                                                   
                                                  Filing Details
                                                  Only the Japanese Pharmacopoeia par...
                                                  Issue/Submission Date
                                                  2015-08-31
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                                                    Pranlukast Hydrate

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                                                    USDMF

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                                                    CEP/COS

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                                                    Japanese DMF

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                                                    227MF10182
                                                    Only the Japanese Pharmacopoeia pra...
                                                    2015-07-13
                                                    Written Confirmation

                                                    Close WC

                                                    Application Number
                                                    227MF10182
                                                    Status
                                                     
                                                    Filing Details
                                                    Only the Japanese Pharmacopoeia pra...
                                                    Issue/Submission Date
                                                    2015-07-13
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                                                      Sertraline Hydrochloride

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                                                      USDMF

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                                                      CEP/COS

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                                                      Japanese DMF

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                                                      226MF10157
                                                      Sertraline hydrochloride salt produ...
                                                      2014-09-01
                                                      Written Confirmation

                                                      Close WC

                                                      Application Number
                                                      226MF10157
                                                      Status
                                                       
                                                      Filing Details
                                                      Sertraline hydrochloride salt produ...
                                                      Issue/Submission Date
                                                      2014-09-01
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                                                        Sivelestat Sodium Hydrate

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                                                        USDMF

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                                                        CEP/COS

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                                                        Japanese DMF

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                                                        226MF10229
                                                        Japanese Pharmacopoeia Sivelestat s...
                                                        2014-12-08
                                                        Written Confirmation

                                                        Close WC

                                                        Application Number
                                                        226MF10229
                                                        Status
                                                         
                                                        Filing Details
                                                        Japanese Pharmacopoeia Sivelestat s...
                                                        Issue/Submission Date
                                                        2014-12-08
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                                                          Solifenacin Succinate

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                                                          USDMF

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                                                          CEP/COS

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                                                          Japanese DMF

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                                                          301MF10110
                                                          Solifenacin succinate production on...
                                                          2019-12-20
                                                          Written Confirmation

                                                          Close WC

                                                          Application Number
                                                          301MF10110
                                                          Status
                                                           
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                                                          Solifenacin succinate production on...
                                                          Issue/Submission Date
                                                          2019-12-20
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                                                            Taltirelin

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                                                            USDMF

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                                                            CEP/COS

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                                                            Japanese DMF

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                                                            224MF10239
                                                            Only the Japanese Pharmacopoeia tal...
                                                            2012-12-28
                                                            Written Confirmation

                                                            Close WC

                                                            Application Number
                                                            224MF10239
                                                            Status
                                                             
                                                            Filing Details
                                                            Only the Japanese Pharmacopoeia tal...
                                                            Issue/Submission Date
                                                            2012-12-28
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                                                              Teprenone

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                                                              USDMF

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                                                              CEP/COS

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                                                              Japanese DMF

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                                                              222MF10245
                                                              Only the Japanese Pharmacopoeia tep...
                                                              2010-10-21
                                                              Written Confirmation

                                                              Close WC

                                                              Application Number
                                                              222MF10245
                                                              Status
                                                               
                                                              Filing Details
                                                              Only the Japanese Pharmacopoeia tep...
                                                              Issue/Submission Date
                                                              2010-10-21
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                                                                Timepidium Bromide

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                                                                USDMF

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                                                                CEP/COS

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                                                                Japanese DMF

                                                                Found JDMF

                                                                218MF10686
                                                                Japanese Pharmacopoeia bromide Chim...
                                                                2006-08-11
                                                                Written Confirmation

                                                                Close WC

                                                                Application Number
                                                                218MF10686
                                                                Status
                                                                 
                                                                Filing Details
                                                                Japanese Pharmacopoeia bromide Chim...
                                                                Issue/Submission Date
                                                                2006-08-11
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                                                                  Tosufloxacin Tosylate

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                                                                  USDMF

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                                                                  303MF10097
                                                                  Japanese Pharmacopoeia Tosufloxacin...
                                                                  2021-06-22
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                                                                  Application Number
                                                                  303MF10097
                                                                  Status
                                                                   
                                                                  Filing Details
                                                                  Japanese Pharmacopoeia Tosufloxacin...
                                                                  Issue/Submission Date
                                                                  2021-06-22
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                                                                    Tramazoline Hydrochloride Monohydrate

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                                                                    Japanese DMF

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                                                                    220MF10207
                                                                    Japan Pharmaceutical Codex tramazol...
                                                                    2008-09-29
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                                                                    Application Number
                                                                    220MF10207
                                                                    Status
                                                                     
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                                                                    Japan Pharmaceutical Codex tramazol...
                                                                    Issue/Submission Date
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                                                                      Valacyclovir Hydrochloride

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                                                                      228MF10197
                                                                      Only the Japanese Pharmacopoeia val...
                                                                      2016-10-17
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                                                                      Application Number
                                                                      228MF10197
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                                                                      Only the Japanese Pharmacopoeia val...
                                                                      Issue/Submission Date
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                                                                        OSC-0617

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                                                                        229MF10122
                                                                        OSC-0617 at 1-1-2 Nishinomiyahama, ...
                                                                        2017-07-11
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                                                                        Application Number
                                                                        229MF10122
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                                                                        OSC-0617 at 1-1-2 Nishinomiyahama, ...
                                                                        Issue/Submission Date
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                                                                          Proxy Villingen

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                                                                          217MF11239
                                                                          Proxy Villingen at 1-1-2 Nishinomiy...
                                                                          2005-12-20
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                                                                          Application Number
                                                                          217MF11239
                                                                          Status
                                                                           
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                                                                          Proxy Villingen at 1-1-2 Nishinomiy...
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                                                                          2005-12-20
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