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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Pku Healthcare Corp., Ltd

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    PKU HEALTHCARE CORP., LTD

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    01 Allopurinol (1)

    02 Amikacin (2)

    03 Amikacin Sulfate (2)

    04 Anidulafungin (1)

    05 Beta Carotene (1)

    06 Buspirone Hydrochloride (1)

    07 Caspofungin (1)

    08 Daptomycin (2)

    09 Doramectin (1)

    10 Everolimus (1)

    11 Glutathione (1)

    12 Hydrochlorothiazide (1)

    13 Ketoprofen (1)

    14 Lovastatin (3)

    15 Lycopene (1)

    16 Meclizine Hydrochloride (1)

    17 Mevastatin (1)

    18 Micafungin (1)

    19 Milbemycin Oxime (2)

    20 Mycophenolate Mofetil (2)

    21 Mycophenolate Sodium (1)

    22 Mycophenolic Acid (1)

    23 Nabumetone (1)

    24 Pravastatin (1)

    25 Simvastatin (2)

    26 Sirolimus (1)

    27 Spinosyn D (1)

    28 Sulfadiazine (2)

    29 Sulfadimidine (1)

    30 Sulfamethoxazole (1)

    31 Teicoplanin (1)

    32 Tobramycin (2)

    33 Trimethoprim (1)

    34 Vancomycin Hydrochloride (1)

    filter

    01 Active (17)

    02 Inactive (11)

    03 Blank (16)

    filter

    01 Expired (1)

    02 Valid (4)

    03 Withdrawn by EDQM Failure to CEP procedure (5)

    04 Withdrawn by Holder (1)

    05 Blank (33)

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    01 218MF10947 (1)

    02 228MF10135 (1)

    03 Blank (42)

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    01 Blank (44)

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      Sulfadiazine

      PDF Supplier PDF
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      USDMF

      Caution USDMF

      22692
      Inactive
      SULFADIAZINE
      2009-04-02
      CEP/COS

      Caution CEP/COS

      R1-CEP 1997-008 - Rev 08
      Withdrawn by EDQM Failure to CEP procedure
      Sulfadiazine
      2015-12-08
      Japanese DMF

      Found JDMF

      228MF10135
      Sulfadiazine at No. 22, Founder Ave...
      2016-07-27
      Written Confirmation

      Close WC

      Application Number
      22692
      R1-CEP 1997-008 - Rev 08
      228MF10135
      Status
      Inactive
      Fees Unpaid
      N/A
      Withdrawn by EDQM Failure to CEP procedure
       
      Filing Details
      SULFADIAZINE
      Sulfadiazine
      Sulfadiazine at No. 22, Founder Ave...
      Issue/Submission Date
      2009-04-02
      2015-12-08
      2016-07-27
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      Tobramycin

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      USDMF

      Found USDMF

      13774
      Active
      TOBRAMYCIN USP
      1998-09-01
      CEP/COS

      Found CEP/COS

      R0-CEP 2019-036 - Rev 00
      Valid
      Tobramycin, EHS Optimized Process
      2019-05-03
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      13774
      R0-CEP 2019-036 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      TOBRAMYCIN USP
      Tobramycin, EHS Optimized Process
      Issue/Submission Date
      1998-09-01
      2019-05-03
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      Vancomycin Hydrochloride

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      USDMF

      Found USDMF

      24185
      Active
      VANCOMYCIN HYDROCHLORIDE
      2010-09-17
      CEP/COS

      Found CEP/COS

      R0-CEP 2018-197 - Rev 00
      Valid
      Vancomycin hydrochloride
      2020-03-18
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      24185
      R0-CEP 2018-197 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      VANCOMYCIN HYDROCHLORIDE
      Vancomycin hydrochloride
      Issue/Submission Date
      2010-09-17
      2020-03-18
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        Ketoprofen

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        USDMF

        Caution USDMF

        8416
        Inactive
        KETOPROFEN USP XXII
        1990-02-01
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Found JDMF

        218MF10947
        Japanese Pharmacopoeia ketoprofen (...
        2006-11-24
        Written Confirmation

        Close WC

        Application Number
        8416
        218MF10947
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        KETOPROFEN USP XXII
        Japanese Pharmacopoeia ketoprofen (...
        Issue/Submission Date
        1990-02-01
        2006-11-24
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        Mycophenolate Mofetil

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        USDMF

        Caution USDMF

        20758
        Inactive
        MYCOPHENOLATE MOFETIL, NON-STERILE ...
        2007-08-07
        CEP/COS

        Found CEP/COS

        R0-CEP 2020-104 - Rev 00
        Valid
        Mycophenolate mofetil
        2022-03-15
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        20758
        R0-CEP 2020-104 - Rev 00
        Status
        Inactive
        Fees Paid
        N/A
        Valid
         
        Filing Details
        MYCOPHENOLATE MOFETIL, NON-STERILE ...
        Mycophenolate mofetil
        Issue/Submission Date
        2007-08-07
        2022-03-15
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          Simvastatin

          PDF Supplier PDF
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          USDMF

          Found USDMF

          23425
          Active
          SIMVASTATIN USP
          2009-12-29
          CEP/COS

          Caution CEP/COS

          R1-CEP 2010-116 - Rev 00
          Withdrawn by EDQM Failure to CEP procedure
          Simvastatin
          2017-06-12
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          23425
          R1-CEP 2010-116 - Rev 00
          Status
          Active
          Fees Unpaid
          Reviewed
          Withdrawn by EDQM Failure to CEP procedure
           
          Filing Details
          SIMVASTATIN USP
          Simvastatin
          Issue/Submission Date
          2009-12-29
          2017-06-12
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            Sulfamethoxazole

            PDF Supplier PDF
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            USDMF

            Found USDMF

            6793
            Active
            SULFAMETHOXAZOLE USP
            1987-01-20
            CEP/COS

            Caution CEP/COS

            R1-CEP 1999-097 - Rev 03
            Withdrawn by EDQM Failure to CEP procedure
            Sulfamethoxazole
            2015-12-08
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            6793
            R1-CEP 1999-097 - Rev 03
            Status
            Active
            Fees Unpaid
            N/A
            Withdrawn by EDQM Failure to CEP procedure
             
            Filing Details
            SULFAMETHOXAZOLE USP
            Sulfamethoxazole
            Issue/Submission Date
            1987-01-20
            2015-12-08
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            Tobramycin

            PDF Supplier PDF
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            See Less

            USDMF

            Found USDMF

            19506
            Active
            TOBRAMYCIN FORM-1 USP
            2006-06-07
            CEP/COS

            Caution CEP/COS

            R1-CEP 1997-103 - Rev 07
            Withdrawn by Holder
            Tobramycin
            2018-09-18
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            19506
            R1-CEP 1997-103 - Rev 07
            Status
            Active
            Fees Paid
            N/A
            Withdrawn by Holder
             
            Filing Details
            TOBRAMYCIN FORM-1 USP
            Tobramycin
            Issue/Submission Date
            2006-06-07
            2018-09-18
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              Trimethoprim

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              USDMF

              Found USDMF

              6795
              Active
              TRIMETHOPRIM USP
              1987-01-20
              CEP/COS

              Caution CEP/COS

              R1-CEP 1997-009 - Rev 05
              Withdrawn by EDQM Failure to CEP procedure
              Trimethoprim
              2015-12-08
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              6795
              R1-CEP 1997-009 - Rev 05
              Status
              Active
              Fees Unpaid
              N/A
              Withdrawn by EDQM Failure to CEP procedure
               
              Filing Details
              TRIMETHOPRIM USP
              Trimethoprim
              Issue/Submission Date
              1987-01-20
              2015-12-08
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              Daptomycin

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              USDMF

              Found USDMF

              29760
              Active
              DAPTOMYCIN, NON-STERILE, BULK DRUG
              2015-11-12
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              29760
              Status
              Active
              Fees Paid
              Reviewed
               
              Filing Details
              DAPTOMYCIN, NON-STERILE, BULK DRUG
              Issue/Submission Date
              2015-11-12
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