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

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    Zhuhai Rundu Pharmaceutical
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    China
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    Address
    No. 6 Airport North Road, Sanzao Town, Jinwan District, Zhuhai City, Guangdong Province
    Telephone
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    +86 (0756)7630655
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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

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            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

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                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

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                  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

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                      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

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                        CEP/COS

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                        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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                          Rabeprazole

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                          USDMF

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                          CEP/COS

                          Close CEP/COS

                          Japanese DMF

                          Found JDMF

                          229MF10007
                          Rabeprazole sodium at No. 6, North ...
                          2017-01-10
                          Written Confirmation

                          Close WC

                          Application Number
                          229MF10007
                          Status
                           
                          Filing Details
                          Rabeprazole sodium at No. 6, North ...
                          Issue/Submission Date
                          2017-01-10
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                            Sacubitril Sodium

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                            USDMF

                            Found USDMF

                            33474
                            Active
                            SACUBITRIL SODIUM
                            2019-01-23
                            CEP/COS

                            Close CEP/COS

                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            33474
                            Status
                            Active
                            Fees Unpaid
                            Reviewed
                             
                            Filing Details
                            SACUBITRIL SODIUM
                            Issue/Submission Date
                            2019-01-23
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                              Sacubitril-Valsartan

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                              USDMF

                              Found USDMF

                              35868
                              Active
                              SACUBITRIL/VALSARTAN
                              2021-04-28
                              CEP/COS

                              Close CEP/COS

                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              35868
                              Status
                              Active
                              Fees Unpaid
                              Reviewed
                               
                              Filing Details
                              SACUBITRIL/VALSARTAN
                              Issue/Submission Date
                              2021-04-28
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                                Telmisartan

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                                USDMF

                                Close USDMF

                                CEP/COS

                                Found CEP/COS

                                R0-CEP 2022-179 - Rev 00
                                Valid
                                Telmisartan
                                2023-08-16
                                Japanese DMF

                                Close JDMF

                                Written Confirmation

                                Close WC

                                Application Number
                                R0-CEP 2022-179 - Rev 00
                                Status
                                Valid
                                 
                                Filing Details
                                Telmisartan
                                Issue/Submission Date
                                2023-08-16
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                                  Valsartan

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                                  USDMF

                                  Found USDMF

                                  32328
                                  Active
                                  VALSARTAN
                                  2017-12-13
                                  CEP/COS

                                  Close CEP/COS

                                  Japanese DMF

                                  Close JDMF

                                  Written Confirmation

                                  Close WC

                                  Application Number
                                  32328
                                  Status
                                  Active
                                  Fees Unpaid
                                  Reviewed
                                   
                                  Filing Details
                                  VALSARTAN
                                  Issue/Submission Date
                                  2017-12-13
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                                    Valsartan

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                                    USDMF

                                    Found USDMF

                                    33471
                                    Active
                                    VALSARTAN DISODIUM
                                    2019-01-28
                                    CEP/COS

                                    Close CEP/COS

                                    Japanese DMF

                                    Close JDMF

                                    Written Confirmation

                                    Close WC

                                    Application Number
                                    33471
                                    Status
                                    Active
                                    Fees Unpaid
                                    Reviewed
                                     
                                    Filing Details
                                    VALSARTAN DISODIUM
                                    Issue/Submission Date
                                    2019-01-28
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                                      Voriconazole

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                                      USDMF

                                      Found USDMF

                                      35869
                                      Active
                                      VORICONAZOLE NON-STERILE BULK DRUG ...
                                      2023-01-16
                                      CEP/COS

                                      Close CEP/COS

                                      Japanese DMF

                                      Close JDMF

                                      Written Confirmation

                                      Close WC

                                      Application Number
                                      35869
                                      Status
                                      Active
                                      Fees Unpaid
                                      N/A
                                       
                                      Filing Details
                                      VORICONAZOLE NON-STERILE BULK DRUG ...
                                      Issue/Submission Date
                                      2023-01-16
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                                        SACUBITRIL CARBOXYL COMPOUND NON-STERILE BULK DRUG SUBS...

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                                        USDMF

                                        Found USDMF

                                        38738
                                        Active
                                        SACUBITRIL CARBOXYL COMPOUND NON-ST...
                                        2023-12-29
                                        CEP/COS

                                        Close CEP/COS

                                        Japanese DMF

                                        Close JDMF

                                        Written Confirmation

                                        Close WC

                                        Application Number
                                        38738
                                        Status
                                        Active
                                        Fees Unpaid
                                        N/A
                                         
                                        Filing Details
                                        SACUBITRIL CARBOXYL COMPOUND NON-ST...
                                        Issue/Submission Date
                                        2023-12-29
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                                          Alogliptin Benzoate

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                                          USDMF

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                                          CEP/COS

                                          Close CEP/COS

                                          Japanese DMF

                                          Close JDMF

                                          Written Confirmation

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                                          Application Number
                                          Status
                                           
                                          Filing Details
                                          Issue/Submission Date
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                                            Amiodarone Hydrochloride

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                                            USDMF

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                                            CEP/COS

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                                            Japanese DMF

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                                            Application Number
                                            Status
                                             
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                                              Azilsartan

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                                              USDMF

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                                              CEP/COS

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                                                Cisatracurium Besylate

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                                                USDMF

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                                                CEP/COS

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                                                  Dasatinib

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                                                  CEP/COS

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                                                  Application Number
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                                                    Dexlansoprazole

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                                                    CEP/COS

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                                                      Diclofenac Sodium

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                                                        Duloxetine

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                                                          Esomeprazole Magnesium

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                                                          CEP/COS

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                                                            Hydrochlorothiazide

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                                                            CEP/COS

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                                                              Ibuprofen

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                                                                Isosorbide Mononitrate

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                                                                  Itopride Hydrochloride

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                                                                    Lanthanum Carbonate

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                                                                        Levobupivacaine

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                                                                          Moxifloxacin Hydrochloride

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                                                                            Piperaquine Phosphate

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                                                                              Posaconazole

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                                                                                Pramipexole Dihydrochloride

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                                                                                  Quinidine sulphate

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                                                                                    Regadenoson Monohydrate

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                                                                                      Sevoflurane

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                                                                                        Sodium Pantothenate

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                                                                                          Tamsulosin

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                                                                                            Thiamphenicol Glycinate

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