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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Chemo Iberica Sa

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    CHEMO IBERICA SA

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    01 Aliskiren (1)

    02 Asenapine Maleate (1)

    03 Fluconazole (1)

    04 Isradipine (1)

    05 Lansoprazole (2)

    06 Levofloxacin (1)

    07 Nedocromil Sodium (1)

    08 Nintedanib Esylate (1)

    09 Omeprazole (1)

    10 Pirfenidone (1)

    11 Rabeprazole (2)

    12 Ranolazine (1)

    13 Sevelamer Carbonate (2)

    14 Sevelamer Hydrochloride (1)

    15 Tamsulosin (1)

    16 Tianeptine Sodium (1)

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    01 Active (10)

    02 Inactive (7)

    03 Blank (2)

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    01 Valid (2)

    02 Withdrawn by Holder (2)

    03 Blank (15)

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    01 Blank (19)

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    01 Blank (19)

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      Pirfenidone

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      USDMF

      Found USDMF

      32796
      Active
      PIRFENIDONE
      2018-05-18
      CEP/COS

      Found CEP/COS

      R0-CEP 2018-127 - Rev 01
      Valid
      Pirfenidone
      2021-10-14
      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      32796
      R0-CEP 2018-127 - Rev 01
      Status
      Active
      Fees Unpaid
      Reviewed
      Valid
       
      Filing Details
      PIRFENIDONE
      Pirfenidone
      Issue/Submission Date
      2018-05-18
      2021-10-14
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        Lansoprazole

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        USDMF

        Found USDMF

        24487
        Active
        LANSOPRAZOLE USP
        2010-12-23
        CEP/COS

        Caution CEP/COS

        R1-CEP 2008-016 - Rev 00
        Withdrawn by Holder
        Lansoprazole
        2014-07-18
        Japanese DMF

        Close JDMF

        Written Confirmation

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        Application Number
        24487
        R1-CEP 2008-016 - Rev 00
        Status
        Active
        Fees Unpaid
        Reviewed
        Withdrawn by Holder
         
        Filing Details
        LANSOPRAZOLE USP
        Lansoprazole
        Issue/Submission Date
        2010-12-23
        2014-07-18
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          Fluconazole

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          USDMF

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          CEP/COS

          Found CEP/COS

          R1-CEP 2015-233 - Rev 00
          Valid
          Fluconazole
          2022-03-16
          Japanese DMF

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          Written Confirmation

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          Application Number
          R1-CEP 2015-233 - Rev 00
          Status
          Valid
           
          Filing Details
          Fluconazole
          Issue/Submission Date
          2022-03-16
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            Isradipine

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            USDMF

            Found USDMF

            17367
            Active
            ISRADIPINE
            2004-05-05
            CEP/COS

            Close CEP/COS

            Japanese DMF

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            Written Confirmation

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            Application Number
            17367
            Status
            Active
            Fees Unpaid
            Reviewed
             
            Filing Details
            ISRADIPINE
            Issue/Submission Date
            2004-05-05
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              Lansoprazole

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              USDMF

              Found USDMF

              29462
              Active
              LANSOPRAZOLE (PROCESS II)
              2015-06-26
              CEP/COS

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              Japanese DMF

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              Written Confirmation

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              Application Number
              29462
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              LANSOPRAZOLE (PROCESS II)
              Issue/Submission Date
              2015-06-26
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                Levofloxacin

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                USDMF

                Found USDMF

                28920
                Active
                LEVOFLOXACIN
                2014-12-15
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                28920
                Status
                Active
                Fees Unpaid
                Reviewed
                 
                Filing Details
                LEVOFLOXACIN
                Issue/Submission Date
                2014-12-15
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                  Nintedanib Esylate

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                  USDMF

                  Found USDMF

                  39158
                  Active
                  NINTEDANIB ESYLATE
                  2023-11-22
                  CEP/COS

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                  Japanese DMF

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                  Written Confirmation

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                  Application Number
                  39158
                  Status
                  Active
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  NINTEDANIB ESYLATE
                  Issue/Submission Date
                  2023-11-22
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                    Rabeprazole

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                    USDMF

                    Found USDMF

                    25309
                    Active
                    RABEPRAZOLE SODIUM (PROCESS II)
                    2011-09-20
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    25309
                    Status
                    Active
                    Fees Unpaid
                    Reviewed
                     
                    Filing Details
                    RABEPRAZOLE SODIUM (PROCESS II)
                    Issue/Submission Date
                    2011-09-20
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                      Ranolazine

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                      USDMF

                      Found USDMF

                      32133
                      Active
                      RANOLAZINE
                      2017-10-13
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

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                      Written Confirmation

                      Close WC

                      Application Number
                      32133
                      Status
                      Active
                      Fees Unpaid
                      Reviewed
                       
                      Filing Details
                      RANOLAZINE
                      Issue/Submission Date
                      2017-10-13
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                        Tamsulosin

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                        USDMF

                        Found USDMF

                        21041
                        Active
                        TAMSULOSIN HYDROCHLORIDE
                        2007-11-16
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        21041
                        Status
                        Active
                        Fees Unpaid
                        Reviewed
                         
                        Filing Details
                        TAMSULOSIN HYDROCHLORIDE
                        Issue/Submission Date
                        2007-11-16
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