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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Nippon Protein Co Ltd

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    Nippon Protein Co Ltd

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    01 Acetylcysteine (3)

    02 Cystine (1)

    03 L-Cysteine (1)

    04 L-Cysteine Hydrochloride (2)

    05 N-Acetylglucosamine (1)

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    01 Active (1)

    02 Inactive (2)

    03 Blank (5)

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    01 Valid (2)

    02 Blank (6)

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    01 217MF10553 (1)

    02 218MF10577 (1)

    03 218MF11012 (1)

    04 220MF10015 (1)

    05 220MF10016 (1)

    06 220MF10106 (1)

    07 224MF10007 (1)

    08 Blank (1)

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    01 Blank (8)

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      Acetylcysteine

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      USDMF

      Caution USDMF

      7816
      Inactive
      N-ACETYL-L-CYSTEINE
      1988-12-15
      CEP/COS

      Found CEP/COS

      R1-CEP 1996-080 - Rev 04
      Valid
      Acetylcysteine
      2020-06-19
      Japanese DMF

      Found JDMF

      224MF10007
      Japanese Pharmacopoeia-acetylcystei...
      2012-01-18
      Written Confirmation

      Close WC

      Application Number
      7816
      R1-CEP 1996-080 - Rev 04
      224MF10007
      Status
      Inactive
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      N-ACETYL-L-CYSTEINE
      Acetylcysteine
      Japanese Pharmacopoeia-acetylcystei...
      Issue/Submission Date
      1988-12-15
      2020-06-19
      2012-01-18
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        L-Cysteine

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        USDMF

        Close USDMF

        CEP/COS

        Found CEP/COS

        R1-CEP 2003-159 - Rev 03
        Valid
        Cysteine Hydrochloride Monohydrate
        2014-08-05
        Japanese DMF

        Found JDMF

        220MF10015
        Japanese Pharmacopoeia L- cysteine ...
        2008-01-09
        Written Confirmation

        Close WC

        Application Number
        R1-CEP 2003-159 - Rev 03
        220MF10015
        Status
        Valid
         
        Filing Details
        Cysteine Hydrochloride Monohydrate
        Japanese Pharmacopoeia L- cysteine ...
        Issue/Submission Date
        2014-08-05
        2008-01-09
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          L-Cysteine Hydrochloride

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          USDMF

          Found USDMF

          21364
          Active
          L-CYSTEINE HYDROCHLORIDE MONOHYDRAT...
          2008-02-26
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Found JDMF

          220MF10016
          Japanese Pharmacopoeia L- cysteine ...
          2008-01-09
          Written Confirmation

          Close WC

          Application Number
          21364
          220MF10016
          Status
          Active
          Fees Unpaid
          Reviewed
           
          Filing Details
          L-CYSTEINE HYDROCHLORIDE MONOHYDRAT...
          Japanese Pharmacopoeia L- cysteine ...
          Issue/Submission Date
          2008-02-26
          2008-01-09
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            Acetylcysteine

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            USDMF

            Close USDMF

            CEP/COS

            Close CEP/COS

            Japanese DMF

            Found JDMF

            218MF10577
            Outsiders regulations acetylcystein...
            2006-06-15
            Written Confirmation

            Close WC

            Application Number
            218MF10577
            Status
             
            Filing Details
            Outsiders regulations acetylcystein...
            Issue/Submission Date
            2006-06-15
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              Acetylcysteine

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              USDMF

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              CEP/COS

              Close CEP/COS

              Japanese DMF

              Found JDMF

              220MF10106
              Outsiders regulations acetylcystein...
              2008-04-11
              Written Confirmation

              Close WC

              Application Number
              220MF10106
              Status
               
              Filing Details
              Outsiders regulations acetylcystein...
              Issue/Submission Date
              2008-04-11
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                Cystine

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                USDMF

                Close USDMF

                CEP/COS

                Close CEP/COS

                Japanese DMF

                Found JDMF

                218MF11012
                Outsiders regulations L- cystine (p...
                2006-12-18
                Written Confirmation

                Close WC

                Application Number
                218MF11012
                Status
                 
                Filing Details
                Outsiders regulations L- cystine (p...
                Issue/Submission Date
                2006-12-18
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                  L-Cysteine Hydrochloride

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                  USDMF

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                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Found JDMF

                  217MF10553
                  L- cysteine ​​hydrochloride (mo...
                  2005-09-09
                  Written Confirmation

                  Close WC

                  Application Number
                  217MF10553
                  Status
                   
                  Filing Details
                  L- cysteine ​​hydrochloride (mo...
                  Issue/Submission Date
                  2005-09-09
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                    N-Acetylglucosamine

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                    USDMF

                    Caution USDMF

                    10770
                    Inactive
                    N-ACETYL-D-GLUCOSAMINE
                    1994-03-11
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    10770
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    N-ACETYL-D-GLUCOSAMINE
                    Issue/Submission Date
                    1994-03-11
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