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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhejiang Lepu Pharmaceutical

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    Zhejiang Lepu Pharmaceutical

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    01 Atorvastatin (2)

    02 Azelastine Hydrochloride (1)

    03 Clopidogrel (1)

    04 Doxazosin Mesylate (1)

    05 Idelalisib (1)

    06 Norfloxacin (1)

    07 Rivaroxaban (1)

    08 Rosuvastatin Calcium (1)

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    01 Active (3)

    02 Blank (6)

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    01 Valid (6)

    02 Blank (3)

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    01 218MF10823 (1)

    02 227MF10255 (1)

    03 Blank (7)

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    01 Blank (9)

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      Atorvastatin

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      USDMF

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      CEP/COS

      Found CEP/COS

      R0-CEP 2022-466 - Rev 00
      Valid
      Atorvastatin calcium, Process 2
      2023-05-12
      Japanese DMF

      Found JDMF

      227MF10255
      Atorvastatin calcium at No. 29 Binh...
      2015-10-21
      Written Confirmation

      Close WC

      Application Number
      R0-CEP 2022-466 - Rev 00
      227MF10255
      Status
      Valid
       
      Filing Details
      Atorvastatin calcium, Process 2
      Atorvastatin calcium at No. 29 Binh...
      Issue/Submission Date
      2023-05-12
      2015-10-21
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        Clopidogrel

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        USDMF

        Found USDMF

        35081
        Active
        CLOPIDOGREL BISULFATE
        2020-09-03
        CEP/COS

        Found CEP/COS

        R0-CEP 2020-408 - Rev 00
        Valid
        Clopidogrel hydrogen sulfate
        2023-01-23
        Japanese DMF

        Close JDMF

        Written Confirmation

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        Application Number
        35081
        R0-CEP 2020-408 - Rev 00
        Status
        Active
        Fees Unpaid
        Reviewed
        Valid
         
        Filing Details
        CLOPIDOGREL BISULFATE
        Clopidogrel hydrogen sulfate
        Issue/Submission Date
        2020-09-03
        2023-01-23
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          Atorvastatin

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          USDMF

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          CEP/COS

          Found CEP/COS

          R1-CEP 2012-139 - Rev 01
          Valid
          Atorvastatin calcium
          2020-08-31
          Japanese DMF

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          Written Confirmation

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          Application Number
          R1-CEP 2012-139 - Rev 01
          Status
          Valid
           
          Filing Details
          Atorvastatin calcium
          Issue/Submission Date
          2020-08-31
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            Azelastine Hydrochloride

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            USDMF

            Found USDMF

            36748
            Active
            AZELASTINE HYDROCHLORIDE, USP
            2022-03-16
            CEP/COS

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            Japanese DMF

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            Written Confirmation

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            Application Number
            36748
            Status
            Active
            Fees Unpaid
            N/A
             
            Filing Details
            AZELASTINE HYDROCHLORIDE, USP
            Issue/Submission Date
            2022-03-16
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              Doxazosin Mesylate

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              USDMF

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              CEP/COS

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              Japanese DMF

              Found JDMF

              218MF10823
              Doxazosin mesylate at No. 29 Binhai...
              2006-10-20
              Written Confirmation

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              Application Number
              218MF10823
              Status
               
              Filing Details
              Doxazosin mesylate at No. 29 Binhai...
              Issue/Submission Date
              2006-10-20
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                Idelalisib

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                USDMF

                Found USDMF

                32519
                Active
                IDELALISIB NON-STERILE BULK DRUG SU...
                2018-03-20
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                32519
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Filing Details
                IDELALISIB NON-STERILE BULK DRUG SU...
                Issue/Submission Date
                2018-03-20
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                  Norfloxacin

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                  USDMF

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                  CEP/COS

                  Found CEP/COS

                  CEP 2006-037 - Rev 04
                  Valid
                  Norfloxacin
                  2024-02-19
                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  CEP 2006-037 - Rev 04
                  Status
                  Valid
                   
                  Filing Details
                  Norfloxacin
                  Issue/Submission Date
                  2024-02-19
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                    Rivaroxaban

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                    USDMF

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                    CEP/COS

                    Found CEP/COS

                    R0-CEP 2021-142 - Rev 00
                    Valid
                    Rivaroxaban
                    2022-11-17
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    R0-CEP 2021-142 - Rev 00
                    Status
                    Valid
                     
                    Filing Details
                    Rivaroxaban
                    Issue/Submission Date
                    2022-11-17
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                      Rosuvastatin Calcium

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                      USDMF

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                      CEP/COS

                      Found CEP/COS

                      R0-CEP 2020-243 - Rev 00
                      Valid
                      Rosuvastatin calcium
                      2022-03-31
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      R0-CEP 2020-243 - Rev 00
                      Status
                      Valid
                       
                      Filing Details
                      Rosuvastatin calcium
                      Issue/Submission Date
                      2022-03-31
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