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

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    Leo Pharma
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    Country
    Country
    Denmark
    Address
    Address
    Industriparken 55
    Telephone
    Telephone
    +45 4494 5888
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    https://www.leo-pharma.com/
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      Calcipotriol

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      USDMF

      Caution USDMF

      8308
      Inactive
      CALCIPOTRIENE DRUG SUBSTANCE
      1989-11-01
      CEP/COS

      Found CEP/COS

      R1-CEP 2005-148 - Rev 01
      Valid
      Calcipotriol
      2013-03-13
      Japanese DMF

      Found JDMF

      219MF10045
      Calcipotriol at Industriparken 55, ...
      2007-02-13
      Written Confirmation

      Close WC

      Application Number
      8308
      R1-CEP 2005-148 - Rev 01
      219MF10045
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      CALCIPOTRIENE DRUG SUBSTANCE
      Calcipotriol
      Calcipotriol at Industriparken 55, ...
      Issue/Submission Date
      1989-11-01
      2013-03-13
      2007-02-13
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        Sodium Fusidate

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        USDMF

        Caution USDMF

        8527
        Inactive
        SODIUM FUSIDATE
        1990-04-16
        CEP/COS

        Found CEP/COS

        R0-CEP 2021-041 - Rev 01
        Valid
        Sodium fusidate Micronised, Process...
        2022-01-19
        Japanese DMF

        Found JDMF

        218MF10952
        Fusidic acid sodium at Industripark...
        2006-11-24
        Written Confirmation

        Close WC

        Application Number
        8527
        R0-CEP 2021-041 - Rev 01
        218MF10952
        Status
        Inactive
        Fees Unpaid
        N/A
        Valid
         
        Filing Details
        SODIUM FUSIDATE
        Sodium fusidate Micronised, Process...
        Fusidic acid sodium at Industripark...
        Issue/Submission Date
        1990-04-16
        2022-01-19
        2006-11-24
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          Calcipotriol

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          USDMF

          Caution USDMF

          8312
          Inactive
          CALCIPOTRIENE OINTMENT
          1989-11-27
          CEP/COS

          Found CEP/COS

          R1-CEP 2005-145 - Rev 01
          Valid
          Calcipotriol monohydrate
          2013-04-09
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          8312
          R1-CEP 2005-145 - Rev 01
          Status
          Inactive
          Fees Unpaid
          N/A
          Valid
           
          Filing Details
          CALCIPOTRIENE OINTMENT
          Calcipotriol monohydrate
          Issue/Submission Date
          1989-11-27
          2013-04-09
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            Fusidic Acid

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            USDMF

            Caution USDMF

            8526
            Inactive
            FUSIDIC ACID
            1990-04-16
            CEP/COS

            Found CEP/COS

            R0-CEP 2021-040 - Rev 01
            Valid
            Fusidic acid Micronised, Process II
            2022-01-19
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            8526
            R0-CEP 2021-040 - Rev 01
            Status
            Inactive
            Fees Unpaid
            N/A
            Valid
             
            Filing Details
            FUSIDIC ACID
            Fusidic acid Micronised, Process II
            Issue/Submission Date
            1990-04-16
            2022-01-19
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              Fusidic Acid

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              USDMF

              Caution USDMF

              8528
              Inactive
              FUCIDIN CREAM
              1990-04-16
              CEP/COS

              Found CEP/COS

              R1-CEP 2009-308 - Rev 02
              Valid
              Fusidic acid Micronised
              2022-01-19
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              8528
              R1-CEP 2009-308 - Rev 02
              Status
              Inactive
              Fees Unpaid
              N/A
              Valid
               
              Filing Details
              FUCIDIN CREAM
              Fusidic acid Micronised
              Issue/Submission Date
              1990-04-16
              2022-01-19
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                Fusidic Acid

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                USDMF

                Caution USDMF

                8529
                Inactive
                FUCIDIN OINTMENT
                1990-04-16
                CEP/COS

                Found CEP/COS

                R1-CEP 2009-379 - Rev 00
                Valid
                Fusidic acid Micronised, sterile
                2016-10-21
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                8529
                R1-CEP 2009-379 - Rev 00
                Status
                Inactive
                Fees Unpaid
                N/A
                Valid
                 
                Filing Details
                FUCIDIN OINTMENT
                Fusidic acid Micronised, sterile
                Issue/Submission Date
                1990-04-16
                2016-10-21
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                  Heparin Sodium

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                  USDMF

                  Caution USDMF

                  10477
                  Inactive
                  WEXPORT LTD. FACILITIES IN LITTLE I...
                  1993-09-03
                  CEP/COS

                  Found CEP/COS

                  R1-CEP 2001-446 - Rev 03
                  Valid
                  Heparin sodium For parenteral prepa...
                  2020-02-21
                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  10477
                  R1-CEP 2001-446 - Rev 03
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                  Valid
                   
                  Filing Details
                  WEXPORT LTD. FACILITIES IN LITTLE I...
                  Heparin sodium For parenteral prepa...
                  Issue/Submission Date
                  1993-09-03
                  2020-02-21
                  ASK
                  US
                  PHARMACOMPASS
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                  your Marketing & Sales content
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                    Alfacalcidol

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                    USDMF

                    Close USDMF

                    CEP/COS

                    Found CEP/COS

                    R1-CEP 2007-286 - Rev 02
                    Valid
                    Alfacalcidol
                    2020-02-18
                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    R1-CEP 2007-286 - Rev 02
                    Status
                    Valid
                     
                    Filing Details
                    Alfacalcidol
                    Issue/Submission Date
                    2020-02-18
                    ASK
                    US
                    PHARMACOMPASS
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                      Calcipotriol

                      PDF Supplier PDF
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                      USDMF

                      Found USDMF

                      10514
                      Active
                      CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
                      1993-10-08
                      CEP/COS

                      Close CEP/COS

                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      10514
                      Status
                      Active
                      Fees Unpaid
                      N/A
                       
                      Filing Details
                      CALCIPOTRIENE HYDRATE DRUG SUBSTANC...
                      Issue/Submission Date
                      1993-10-08
                      ASK
                      US
                      PHARMACOMPASS
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                        Calcipotriol

                        PDF Supplier PDF
                        URL Supplier Web Content
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                        See Less

                        USDMF

                        Found USDMF

                        10515
                        Active
                        CALCIPOTRIENE CREAM
                        1993-10-08
                        CEP/COS

                        Close CEP/COS

                        Japanese DMF

                        Close JDMF

                        Written Confirmation

                        Close WC

                        Application Number
                        10515
                        Status
                        Active
                        Fees Unpaid
                        N/A
                         
                        Filing Details
                        CALCIPOTRIENE CREAM
                        Issue/Submission Date
                        1993-10-08
                        ASK
                        US
                        PHARMACOMPASS
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                          Heparin Sodium

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                          USDMF

                          Caution USDMF

                          10589
                          Inactive
                          HEPARIN SODIUM DRUG SUBSTANCE
                          1993-11-22
                          CEP/COS

                          Caution CEP/COS

                          R1-CEP 2001-445 - Rev 02
                          Withdrawn by Holder
                          Heparin sodium Potency not less tha...
                          2011-03-30
                          Japanese DMF

                          Close JDMF

                          Written Confirmation

                          Close WC

                          Application Number
                          10589
                          R1-CEP 2001-445 - Rev 02
                          Status
                          Inactive
                          Fees Unpaid
                          N/A
                          Withdrawn by Holder
                           
                          Filing Details
                          HEPARIN SODIUM DRUG SUBSTANCE
                          Heparin sodium Potency not less tha...
                          Issue/Submission Date
                          1993-11-22
                          2011-03-30
                          ASK
                          US
                          PHARMACOMPASS
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                          your Marketing & Sales content
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                            Sodium Fusidate

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                            See Less

                            USDMF

                            Close USDMF

                            CEP/COS

                            Found CEP/COS

                            R0-CEP 2021-042 - Rev 00
                            Valid
                            Sodium fusidate Process II
                            2021-06-04
                            Japanese DMF

                            Close JDMF

                            Written Confirmation

                            Close WC

                            Application Number
                            R0-CEP 2021-042 - Rev 00
                            Status
                            Valid
                             
                            Filing Details
                            Sodium fusidate Process II
                            Issue/Submission Date
                            2021-06-04
                            ASK
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                            PHARMACOMPASS
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                              Sodium Fusidate

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                              USDMF

                              Close USDMF

                              CEP/COS

                              Found CEP/COS

                              R1-CEP 2009-317 - Rev 02
                              Valid
                              Sodium fusidate Micronised
                              2022-01-19
                              Japanese DMF

                              Close JDMF

                              Written Confirmation

                              Close WC

                              Application Number
                              R1-CEP 2009-317 - Rev 02
                              Status
                              Valid
                               
                              Filing Details
                              Sodium fusidate Micronised
                              Issue/Submission Date
                              2022-01-19
                              ASK
                              US
                              PHARMACOMPASS
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                              your Marketing & Sales content
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                                Sodium Fusidate

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                                URL Supplier Web Content
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                                USDMF

                                Close USDMF

                                CEP/COS

                                Found CEP/COS

                                R1-CEP 2009-309 - Rev 00
                                Valid
                                Sodium fusidate
                                2016-07-29
                                Japanese DMF

                                Close JDMF