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

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    01 Butenafine Hydrochloride (1)

    02 Glimepiride (1)

    03 Mosapride Citrate (1)

    04 Naftopidil (1)

    05 Pioglitazone (1)

    06 Rebamipide (1)

    07 Temocapril Hydrochloride (1)

    08 Terbinafine Hydrochloride (1)

    09 Voglibose (1)

    filter

    01 Blank (9)

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    01 Valid (1)

    02 Blank (8)

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    01 218MF10849 (1)

    02 219MF10342 (1)

    03 220MF10173 (1)

    04 221MF10122 (1)

    05 221MF10212 (1)

    06 222MF10077 (1)

    07 223MF10028 (1)

    08 224MF10218 (1)

    09 225MF10151 (1)

    filter

    01 Blank (9)

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      Glimepiride

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      USDMF

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      CEP/COS

      Found CEP/COS

      R1-CEP 2006-202 - Rev 02
      Valid
      Glimepiride
      2016-02-23
      Japanese DMF

      Found JDMF

      221MF10122
      Glimepiride at 500, Sinnae-ro, Geum...
      2009-06-16
      Written Confirmation

      Close WC

      Application Number
      R1-CEP 2006-202 - Rev 02
      221MF10122
      Status
      Valid
       
      Filing Details
      Glimepiride
      Glimepiride at 500, Sinnae-ro, Geum...
      Issue/Submission Date
      2016-02-23
      2009-06-16
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        Butenafine Hydrochloride

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        USDMF

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        CEP/COS

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        Japanese DMF

        Found JDMF

        221MF10212
        Butenafine Hydrochloride at 500, Si...
        2009-09-28
        Written Confirmation

        Close WC

        Application Number
        221MF10212
        Status
         
        Filing Details
        Butenafine Hydrochloride at 500, Si...
        Issue/Submission Date
        2009-09-28
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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

          225MF10151
          Mosapride acid hydrate at 500, Sinn...
          2013-08-09
          Written Confirmation

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          Application Number
          225MF10151
          Status
           
          Filing Details
          Mosapride acid hydrate at 500, Sinn...
          Issue/Submission Date
          2013-08-09
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            Naftopidil

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            USDMF

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            CEP/COS

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            Japanese DMF

            Found JDMF

            224MF10218
            Naftopidil at 500, Sinnae-ro, Geumw...
            2012-11-14
            Written Confirmation

            Close WC

            Application Number
            224MF10218
            Status
             
            Filing Details
            Naftopidil at 500, Sinnae-ro, Geumw...
            Issue/Submission Date
            2012-11-14
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              Pioglitazone

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              USDMF

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              CEP/COS

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              Japanese DMF

              Found JDMF

              222MF10077
              Pioglitazone at 500, Sinnae-ro, Geu...
              2010-03-02
              Written Confirmation

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              Application Number
              222MF10077
              Status
               
              Filing Details
              Pioglitazone at 500, Sinnae-ro, Geu...
              Issue/Submission Date
              2010-03-02
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                Rebamipide

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                USDMF

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                CEP/COS

                Close CEP/COS

                Japanese DMF

                Found JDMF

                218MF10849
                REBAMIPIDE at 500, Sinnae-ro, Geumw...
                2006-10-20
                Written Confirmation

                Close WC

                Application Number
                218MF10849
                Status
                 
                Filing Details
                REBAMIPIDE at 500, Sinnae-ro, Geumw...
                Issue/Submission Date
                2006-10-20
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                  Temocapril Hydrochloride

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                  USDMF

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                  CEP/COS

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                  Japanese DMF

                  Found JDMF

                  219MF10342
                  Temocapril Hydrochloride at 500, Si...
                  2007-11-21
                  Written Confirmation

                  Close WC

                  Application Number
                  219MF10342
                  Status
                   
                  Filing Details
                  Temocapril Hydrochloride at 500, Si...
                  Issue/Submission Date
                  2007-11-21
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                    Terbinafine Hydrochloride

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                    USDMF

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                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Found JDMF

                    220MF10173
                    Terbinafine hydrochloride at 500, S...
                    2008-07-31
                    Written Confirmation

                    Close WC

                    Application Number
                    220MF10173
                    Status
                     
                    Filing Details
                    Terbinafine hydrochloride at 500, S...
                    Issue/Submission Date
                    2008-07-31
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                      Voglibose

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                      USDMF

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                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Found JDMF

                      223MF10028
                      Japanese Pharmacopoeia voglibose at...
                      2011-02-25
                      Written Confirmation

                      Close WC

                      Application Number
                      223MF10028
                      Status
                       
                      Filing Details
                      Japanese Pharmacopoeia voglibose at...
                      Issue/Submission Date
                      2011-02-25
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