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

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    01 Alogliptin Benzoate (1)

    02 Amiodarone Hydrochloride (1)

    03 Azilsartan (1)

    04 Candesartan (1)

    05 Candesartan Cilexetil (2)

    06 Cisatracurium Besylate (1)

    07 Dasatinib (1)

    08 Dexlansoprazole (1)

    09 Diclofenac Sodium (1)

    10 Duloxetine (1)

    11 Esomeprazole Magnesium (1)

    12 Hydrochlorothiazide (1)

    13 Hydroxychloroquine Sulphate (1)

    14 Ibuprofen (1)

    15 Irbesartan (2)

    16 Isosorbide Mononitrate (1)

    17 Itopride Hydrochloride (1)

    18 Lansoprazole (1)

    19 Lanthanum Carbonate (1)

    20 Lesinurad (1)

    21 Levobupivacaine (1)

    22 Moxifloxacin Hydrochloride (1)

    23 Olmesartan Medoxomil (1)

    24 Piperaquine Phosphate (1)

    25 Posaconazole (1)

    26 Pramipexole Dihydrochloride (1)

    27 Quinidine sulphate (1)

    28 Rabeprazole (2)

    29 Regadenoson Monohydrate (1)

    30 Sacubitril Sodium (1)

    31 Sacubitril-Valsartan (1)

    32 Sevoflurane (1)

    33 Sodium Pantothenate (1)

    34 Tamsulosin (1)

    35 Telmisartan (1)

    36 Thiamphenicol Glycinate (1)

    37 Valsartan (3)

    38 Voriconazole (1)

    39 Blank (1)

    filter

    01 Active (10)

    02 Inactive (2)

    03 Blank (32)

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    01 Valid (6)

    02 Blank (38)

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    01 228MF10201 (1)

    02 229MF10007 (1)

    03 230MF10096 (1)

    04 231MF10050 (1)

    05 231MF10084 (1)

    06 301MF10035 (1)

    07 304MF10083 (1)

    08 Blank (37)

    filter

    01 Blank (44)

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      Olmesartan Medoxomil

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      USDMF

      Found USDMF

      34941
      Active
      OLMESARTAN MEDOXOMIL
      2020-12-23
      CEP/COS

      Found CEP/COS

      R1-CEP 2014-121 - Rev 01
      Valid
      Olmesartan medoxomil
      2021-01-28
      Japanese DMF

      Found JDMF

      230MF10096
      Olmesartan Medoxomil at No. 6, Nort...
      2018-08-02
      Written Confirmation

      Close WC

      Application Number
      34941
      R1-CEP 2014-121 - Rev 01
      230MF10096
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      OLMESARTAN MEDOXOMIL
      Olmesartan medoxomil
      Olmesartan Medoxomil at No. 6, Nort...
      Issue/Submission Date
      2020-12-23
      2021-01-28
      2018-08-02
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        Valsartan

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        USDMF

        Caution USDMF

        25510
        Inactive
        VALSARTAN
        2011-11-14
        CEP/COS

        Found CEP/COS

        R0-CEP 2019-106 - Rev 01
        Valid
        Valsartan
        2022-05-03
        Japanese DMF

        Found JDMF

        304MF10083
        Valsartan at No. 6, North Airport R...
        2022-06-01
        Written Confirmation

        Close WC

        Application Number
        25510
        R0-CEP 2019-106 - Rev 01
        304MF10083
        Status
        Inactive
        Fees Unpaid
        N/A
        Valid
         
        Filing Details
        VALSARTAN
        Valsartan
        Valsartan at No. 6, North Airport R...
        Issue/Submission Date
        2011-11-14
        2022-05-03
        2022-06-01
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          Candesartan Cilexetil

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          USDMF

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          CEP/COS

          Found CEP/COS

          R0-CEP 2023-096 - Rev 00
          Valid
          Candesartan cilexetil, Process 2
          2023-05-19
          Japanese DMF

          Found JDMF

          228MF10201
          Candesartan cilexetil at No. 6, Nor...
          2016-10-21
          Written Confirmation

          Close WC

          Application Number
          R0-CEP 2023-096 - Rev 00
          228MF10201
          Status
          Valid
           
          Filing Details
          Candesartan cilexetil, Process 2
          Candesartan cilexetil at No. 6, Nor...
          Issue/Submission Date
          2023-05-19
          2016-10-21
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            Hydroxychloroquine Sulphate

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            USDMF

            Found USDMF

            34940
            Active
            HYDROXYCHLOROQUINE SULFATE
            2022-01-26
            CEP/COS

            Found CEP/COS

            R0-CEP 2021-317 - Rev 00
            Valid
            Hydroxychloroquine sulfate
            2023-02-16
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            34940
            R0-CEP 2021-317 - Rev 00
            Status
            Active
            Fees Unpaid
            N/A
            Valid
             
            Filing Details
            HYDROXYCHLOROQUINE SULFATE
            Hydroxychloroquine sulfate
            Issue/Submission Date
            2022-01-26
            2023-02-16
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              Irbesartan

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              USDMF

              Caution USDMF

              25509
              Inactive
              IRBESARTAN
              2011-11-14
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Found JDMF

              301MF10035
              Irbesartan at No. 6, North Airport ...
              2019-07-31
              Written Confirmation

              Close WC

              Application Number
              25509
              301MF10035
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              IRBESARTAN
              Irbesartan at No. 6, North Airport ...
              Issue/Submission Date
              2011-11-14
              2019-07-31
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                Candesartan

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                USDMF

                Found USDMF

                37468
                Active
                CANDESARTAN CILEXETIL NON-STERILE B...
                2022-11-04
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                37468
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                CANDESARTAN CILEXETIL NON-STERILE B...
                Issue/Submission Date
                2022-11-04
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                  Candesartan Cilexetil

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                  USDMF

                  Close USDMF

                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2013-314 - Rev 01
                  Valid
                  Candesartan cilexetil
                  2021-01-25
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  R1-CEP 2013-314 - Rev 01
                  Status
                  Valid
                   
                  Filing Details
                  Candesartan cilexetil
                  Issue/Submission Date
                  2021-01-25
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                    Irbesartan

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                    USDMF

                    Found USDMF

                    32803
                    Active
                    IRBESARTAN, NON-STERILE BULK DRUG S...
                    2019-11-12
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    32803
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                     
                    Filing Details
                    IRBESARTAN, NON-STERILE BULK DRUG S...
                    Issue/Submission Date
                    2019-11-12
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                      Lansoprazole

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                      USDMF

                      Close USDMF

                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Found JDMF

                      231MF10084
                      Japanese Pharmacopoeia Lansoprazole...
                      2019-04-05
                      Written Confirmation

                      Close WC

                      Application Number
                      231MF10084
                      Status
                       
                      Filing Details
                      Japanese Pharmacopoeia Lansoprazole...
                      Issue/Submission Date
                      2019-04-05
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                        Rabeprazole

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                        USDMF

                        Close USDMF

                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Found JDMF

                        231MF10050
                        Rabeprazole Sodium at No. 6, North ...
                        2019-02-21
                        Written Confirmation

                        Close WC

                        Application Number
                        231MF10050
                        Status
                         
                        Filing Details
                        Rabeprazole Sodium at No. 6, North ...
                        Issue/Submission Date
                        2019-02-21
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