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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
    China Flag
    Country
    Country
    China
    Address
    Address
    Haidian District, Beijing Zhongguancun 298 Chengfu Founder Building 7th Floor 100871
    Telephone
    Telephone
    +86 10 5172 2801
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.pkucare.com/
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    Linkedin
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      Sulfadiazine

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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      Withdrawn by EDQM Failure to CEP procedure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      Withdrawn by EDQM Failure to CEP procedure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

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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

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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

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            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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              Daptomycin

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              USDMF

              Found USDMF

              35241
              Active
              DAPTOMYCIN
              2020-09-23
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              35241
              Status
              Active
              Fees Paid
              N/A
               
              Filing Details
              DAPTOMYCIN
              Issue/Submission Date
              2020-09-23
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              Lovastatin

              PDF Supplier PDF
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              See Less

              USDMF

              Found USDMF

              20061
              Active
              LOVASTATIN
              2006-12-19
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              20061
              Status
              Active
              Fees Paid
              N/A
               
              Filing Details
              LOVASTATIN
              Issue/Submission Date
              2006-12-19
              ASK
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              Lovastatin

              PDF Supplier PDF
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              See Less

              USDMF

              Found USDMF

              35431
              Active
              LOVASTATIN
              2020-12-11
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              35431
              Status
              Active
              Fees Paid
              N/A
               
              Filing Details
              LOVASTATIN
              Issue/Submission Date
              2020-12-11
              ASK
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                Meclizine Hydrochloride

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                See Less

                USDMF

                Found USDMF

                19419
                Active
                MECLIZINE HYDROCHLORIDE
                2006-04-28
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                19419
                Status
                Active
                Fees Unpaid
                N/A
                 
                Filing Details
                MECLIZINE HYDROCHLORIDE
                Issue/Submission Date
                2006-04-28
                ASK
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                Mevastatin

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                USDMF

                Found USDMF

                28531
                Active
                MEVASTATIN
                2014-07-31
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                28531
                Status
                Active
                Fees Paid
                N/A
                 
                Filing Details
                MEVASTATIN
                Issue/Submission Date
                2014-07-31
                ASK
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                Milbemycin Oxime

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                See Less

                USDMF

                Close USDMF

                CEP/COS

                Found CEP/COS

                R0-CEP 2020-241 - Rev 00
                Valid
                Milbemycin oxime for veterinary use
                2022-09-20
                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                R0-CEP 2020-241 - Rev 00
                Status
                Valid
                 
                Filing Details
                Milbemycin oxime for veterinary use
                Issue/Submission Date
                2022-09-20
                ASK
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                Mycophenolate Mofetil

                PDF Supplier PDF
                URL Supplier Web Content
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                See Less

                USDMF

                Found USDMF

                36449
                Active
                MYCOPHENOLATE MOFETIL
                2021-12-01
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                36449
                Status
                Active
                Fees Paid
                Reviewed
                 
                Filing Details
                MYCOPHENOLATE MOFETIL
                Issue/Submission Date
                2021-12-01
                ASK
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                Mycophenolate Sodium

                PDF Supplier PDF
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                USDMF

                Found USDMF

                37876
                Active
                MYCOPHENOLATE SODIUM
                2023-02-20
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                37876
                Status
                Active
                Fees Paid
                N/A
                 
                Filing Details
                MYCOPHENOLATE SODIUM
                Issue/Submission Date
                2023-02-20
                ASK
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                Mycophenolic Acid

                PDF Supplier PDF
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                USDMF

                Found USDMF

                20452
                Active
                MYCOPHENOLIC ACID
                2007-04-17
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                20452
                Status
                Active
                Fees Paid
                N/A
                 
                Filing Details
                MYCOPHENOLIC ACID
                Issue/Submission Date
                2007-04-17
                ASK
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                  Nabumetone

                  PDF Supplier PDF
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                  USDMF

                  Found USDMF

                  18581
                  Active
                  NABUMETONE USP
                  2005-06-24
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  18581
                  Status
                  Active
                  Fees Unpaid
                  Reviewed
                   
                  Filing Details
                  NABUMETONE USP
                  Issue/Submission Date
                  2005-06-24
                  ASK
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                  Sirolimus

                  PDF Supplier PDF
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                  USDMF

                  Found USDMF

                  31052
                  Active
                  SIROLIMUS
                  2016-10-05
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  31052
                  Status
                  Active
                  Fees Paid
                  N/A
                   
                  Filing Details
                  SIROLIMUS
                  Issue/Submission Date
                  2016-10-05
                  ASK
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                  Allopurinol

                  PDF Supplier PDF
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                  USDMF

                  Caution USDMF

                  23954
                  Inactive
                  ALLOPURINOL
                  2010-07-07
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  23954
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  ALLOPURINOL
                  Issue/Submission Date
                  2010-07-07
                  ASK
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                  Amikacin

                  PDF Supplier PDF
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                  USDMF

                  Caution USDMF

                  13760
                  Inactive
                  AMIKACIN BASE
                  1998-09-01
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  13760
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  AMIKACIN BASE
                  Issue/Submission Date
                  1998-09-01
                  ASK
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                  Amikacin

                  PDF Supplier PDF
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                  See Less

                  USDMF

                  Caution USDMF

                  14007
                  Inactive
                  AMIKACIN HYDROCHLORIDE, NON-STERILE...
                  1999-03-05
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  14007
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  AMIKACIN HYDROCHLORIDE, NON-STERILE...
                  Issue/Submission Date
                  1999-03-05
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                  Amikacin Sulfate

                  PDF Supplier PDF
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                  USDMF

                  Caution USDMF

                  13788
                  Inactive
                  AMIKACIN SULFATE (1:2) USP
                  1998-09-01
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  13788
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  AMIKACIN SULFATE (1:2) USP
                  Issue/Submission Date
                  1998-09-01
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                  Amikacin Sulfate

                  PDF Supplier PDF
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                  USDMF

                  Caution USDMF

                  21035
                  Inactive
                  Amikacin Sulfate (1:1.8) USP, Non-S...
                  2007-11-09
                  CEP/COS

                  Close CEP/COS

                  Japanese DMF

                  Close JDMF

                  Written Confirmation

                  Close WC

                  Application Number
                  21035
                  Status
                  Inactive
                  Fees Paid
                  N/A
                   
                  Filing Details
                  Amikacin Sulfate (1:1.8) USP, Non-S...
                  Issue/Submission Date
                  2007-11-09
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                    Buspirone Hydrochloride

                    PDF Supplier PDF
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                    USDMF

                    Caution USDMF

                    15163
                    Inactive
                    BUSPIRONE HYDROCHLORIDE
                    2000-11-28
                    CEP/COS

                    Close CEP/COS

                    Japanese DMF

                    Close JDMF

                    Written Confirmation

                    Close WC

                    Application Number
                    15163
                    Status
                    Inactive
                    Fees Unpaid
                    N/A
                     
                    Filing Details
                    BUSPIRONE HYDROCHLORIDE
                    Issue/Submission Date
                    2000-11-28
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                      Hydrochlorothiazide

                      PDF Supplier PDF
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                      See Less

                      USDMF

                      Close USDMF

                      CEP/COS

                      Caution CEP/COS

                      R0-CEP 2006-116 - Rev 00
                      Expired
                      Hydrochlorothiazide
                      2008-01-18
                      Japanese DMF

                      Close JDMF

                      Written Confirmation

                      Close WC

                      Application Number
                      R0-CEP 2006-116 - Rev 00
                      Status
                      Expired
                       
                      Filing Details
                      Hydrochlorothiazide
                      Issue/Submission Date
                      2008-01-18
                      ASK
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                      Lovastatin

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                      12496
                      Inactive
                      LOVASTATIN, USP
                      1997-05-08
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                      Application Number
                      12496
                      Status
                      Inactive
                      Fees Paid
                      N/A
                       
                      Filing Details
                      LOVASTATIN, USP
                      Issue/Submission Date
                      1997-05-08
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                        Simvastatin

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                        24967
                        Inactive
                        SIMVASTATIN AMMONIUM SALT
                        2011-04-29
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                        Application Number
                        24967
                        Status
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                        Fees Unpaid
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                        SIMVASTATIN AMMONIUM SALT
                        Issue/Submission Date
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                          R1-CEP 1995-039 - Rev 06
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                          Sulfadimidine
                          2015-12-08
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                          Application Number
                          R1-CEP 1995-039 - Rev 06
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                          Sulfadimidine
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