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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Assurgen Pharma

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    01 Divalproex Sodium (1)

    02 Etoricoxib (1)

    03 Itraconazole (1)

    04 Pantoprazole Sodium (1)

    05 Sodium Valproate (1)

    06 Tadalafil (1)

    07 Verapamil Hydrochloride (1)

    08 Vildagliptin (1)

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    01 Blank (8)

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    01 Valid (5)

    02 Blank (3)

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    01 Blank (8)

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    01 WC-0428 (5)

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      Pantoprazole Sodium

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      USDMF

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      CEP/COS

      Found CEP/COS

      R0-CEP 2018-199 - Rev 00
      Valid
      Pantoprazole sodium sesquihydrate
      2020-04-16
      Japanese DMF

      Close JDMF

      Written Confirmation

      Found WC

      Indian CDSCO WC-0428
      Valid
      Pantoprazole Sodium SesquihydrateEP
      2021-09-17
      Application Number
      R0-CEP 2018-199 - Rev 00
      Indian CDSCO WC-0428
      Status
      Valid
       
      Valid
      2024-10-07
      Filing Details
      Pantoprazole sodium sesquihydrate
      Pantoprazole Sodium SesquihydrateEP
      Issue/Submission Date
      2020-04-16
      2021-09-17
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        Verapamil Hydrochloride

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        USDMF

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        CEP/COS

        Found CEP/COS

        R0-CEP 2019-014 - Rev 01
        Valid
        Verapamil hydrochloride
        2023-02-20
        Japanese DMF

        Close JDMF

        Written Confirmation

        Found WC

        Indian CDSCO WC-0428
        Valid
        VERAPAMIL HCL EP
        2021-09-17
        Application Number
        R0-CEP 2019-014 - Rev 01
        Indian CDSCO WC-0428
        Status
        Valid
         
        Valid
        2024-10-07
        Filing Details
        Verapamil hydrochloride
        VERAPAMIL HCL EP
        Issue/Submission Date
        2023-02-20
        2021-09-17
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          Divalproex Sodium

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          USDMF

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          CEP/COS

          Found CEP/COS

          R0-CEP 2020-374 - Rev 00
          Valid
          Valproic acid
          2021-08-13
          Japanese DMF

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          Written Confirmation

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          Application Number
          R0-CEP 2020-374 - Rev 00
          Status
          Valid
           
          Filing Details
          Valproic acid
          Issue/Submission Date
          2021-08-13
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            Etoricoxib

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            USDMF

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            CEP/COS

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            Japanese DMF

            Close JDMF

            Written Confirmation

            Found WC

            Indian CDSCO WC-0428
            Valid
            Etoricoxib IH
            2021-09-17
            Application Number
            Indian CDSCO WC-0428
            Status
             
            Valid
            2024-10-07
            Filing Details
            Etoricoxib IH
            Issue/Submission Date
            2021-09-17
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              Itraconazole

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              USDMF

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              CEP/COS

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              Japanese DMF

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              Written Confirmation

              Found WC

              Indian CDSCO WC-0428
              Valid
              Itraconazole EP
              2021-09-17
              Application Number
              Indian CDSCO WC-0428
              Status
               
              Valid
              2024-10-07
              Filing Details
              Itraconazole EP
              Issue/Submission Date
              2021-09-17
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                Sodium Valproate

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                USDMF

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                CEP/COS

                Found CEP/COS

                R0-CEP 2020-373 - Rev 00
                Valid
                Sodium valproate
                2021-09-13
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                R0-CEP 2020-373 - Rev 00
                Status
                Valid
                 
                Filing Details
                Sodium valproate
                Issue/Submission Date
                2021-09-13
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                  Tadalafil

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                  USDMF

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                  CEP/COS

                  Found CEP/COS

                  R0-CEP 2021-498 - Rev 00
                  Valid
                  Tadalafil
                  2023-08-30
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  R0-CEP 2021-498 - Rev 00
                  Status
                  Valid
                   
                  Filing Details
                  Tadalafil
                  Issue/Submission Date
                  2023-08-30
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                    Vildagliptin

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                    USDMF

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                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Found WC

                    Indian CDSCO WC-0428
                    Valid
                    Vildagliptin IH
                    2021-09-17
                    Application Number
                    Indian CDSCO WC-0428
                    Status
                     
                    Valid
                    2024-10-07
                    Filing Details
                    Vildagliptin IH
                    Issue/Submission Date
                    2021-09-17
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