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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Boryung Pharmaceutical Co., Ltd

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    Boryung Pharmaceutical Co., Ltd

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    01 Alacepril (1)

    02 Aripiprazole (1)

    03 Cilnidipine (1)

    04 Dapagliflozin (1)

    05 Dasatinib (1)

    06 Donepezil (1)

    07 Doxorubicin Hydrochloride (2)

    08 Edoxaban Tosylate (1)

    09 Empagliflozin (1)

    10 Fesoterodine (1)

    11 Fexofenadine Hydrochloride (1)

    12 Fimasartan (1)

    13 Lafutidine (1)

    14 Linezolid (1)

    15 Montelukast Sodium (1)

    16 Pitavastatin (1)

    17 Tamsulosin (1)

    18 Torsemide (1)

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    01 Blank (19)

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    01 Valid (1)

    02 Withdrawn by Holder (1)

    03 Blank (17)

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    01 220MF10056 (1)

    02 224MF10052 (1)

    03 224MF10127 (1)

    04 226MF10100 (1)

    05 227MF10047 (1)

    06 228MF10038 (1)

    07 303MF10015 (1)

    08 Blank (12)

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    01 Blank (19)

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      Alacepril

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      220MF10056
      Alacepril at 136, Changgyeonggung-r...
      2008-02-08
      Written Confirmation

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      Application Number
      220MF10056
      Status
       
      Filing Details
      Alacepril at 136, Changgyeonggung-r...
      Issue/Submission Date
      2008-02-08
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        Aripiprazole

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        228MF10038
        Aripiprazole at 136, Changgyeonggun...
        2016-02-08
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        Application Number
        228MF10038
        Status
         
        Filing Details
        Aripiprazole at 136, Changgyeonggun...
        Issue/Submission Date
        2016-02-08
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          Dasatinib

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          303MF10015
          Dasatinib at 136, Changgyeonggung-r...
          2021-01-26
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          Application Number
          303MF10015
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          Dasatinib at 136, Changgyeonggung-r...
          Issue/Submission Date
          2021-01-26
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            Doxorubicin Hydrochloride

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            USDMF

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            CEP/COS

            Found CEP/COS

            R1-CEP 2010-324 - Rev 01
            Valid
            Doxorubicin Hydrochloride, Syntheti...
            2017-07-17
            Japanese DMF

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            Application Number
            R1-CEP 2010-324 - Rev 01
            Status
            Valid
             
            Filing Details
            Doxorubicin Hydrochloride, Syntheti...
            Issue/Submission Date
            2017-07-17
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              Fexofenadine Hydrochloride

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              224MF10052
              Fexofenadine hydrochloride at 136, ...
              2012-03-12
              Written Confirmation

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              Application Number
              224MF10052
              Status
               
              Filing Details
              Fexofenadine hydrochloride at 136, ...
              Issue/Submission Date
              2012-03-12
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                Montelukast Sodium

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                CEP/COS

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                227MF10047
                Montelukast Sodium at 136, Changgye...
                2015-02-09
                Written Confirmation

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                Application Number
                227MF10047
                Status
                 
                Filing Details
                Montelukast Sodium at 136, Changgye...
                Issue/Submission Date
                2015-02-09
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                  Pitavastatin

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                  CEP/COS

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                  Japanese DMF

                  Found JDMF

                  224MF10127
                  Pitavastatin calcium at Boryung Bld...
                  2012-07-18
                  Written Confirmation

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                  Application Number
                  224MF10127
                  Status
                   
                  Filing Details
                  Pitavastatin calcium at Boryung Bld...
                  Issue/Submission Date
                  2012-07-18
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                    Tamsulosin

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                    CEP/COS

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                    226MF10100
                    Tamsulosin hydrochloride at 136, Ch...
                    2014-05-14
                    Written Confirmation

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                    Application Number
                    226MF10100
                    Status
                     
                    Filing Details
                    Tamsulosin hydrochloride at 136, Ch...
                    Issue/Submission Date
                    2014-05-14
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                      Doxorubicin Hydrochloride

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                      USDMF

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                      CEP/COS

                      Caution CEP/COS

                      R1-CEP 1998-030 - Rev 00
                      Withdrawn by Holder
                      Doxorubicin Hydrochloride
                      2007-03-05
                      Japanese DMF

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                      Written Confirmation

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                      Application Number
                      R1-CEP 1998-030 - Rev 00
                      Status
                      Withdrawn by Holder
                       
                      Filing Details
                      Doxorubicin Hydrochloride
                      Issue/Submission Date
                      2007-03-05
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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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                        Application Number
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