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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by PKU HEALTHCARE CORP., LTD to the U.S. FDA. Original Data : FDA Website

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    PKU HEALTHCARE CORP., LTD
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    Country
    Country
    China
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    Address
    Haidian District, Beijing Zhongguancun 298 Chengfu Founder Building 7th Floor 100871
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    +86 10 5172 2801
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    enquiries@pharmacompass.com
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    http://www.pkucare.com/
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    ALLOPURINOL

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    PKU HEALTHCARE CORP L...
    Inactive
    23954
    N/A
    2010-07-07
    II
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    AMIKACIN BASE

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    PKUCARE CHONGQING DAX...
    Inactive
    13760
    N/A
    1998-09-01
    II
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    AMIKACIN HYDROCHLORIDE, NON-STERILE...

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    CHONGQING DAXIN PHARM...
    Inactive
    14007
    N/A
    1999-03-05
    II
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    Amikacin Sulfate (1:1.8) USP, Non-S...

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    PKUCARE CHONGQING DAX...
    Inactive
    21035
    N/A
    2007-11-09
    II
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    AMIKACIN SULFATE (1:2) USP

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    CHONGQING DAXIN PHARM...
    Inactive
    13788
    N/A
    1998-09-01
    II
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      BUSPIRONE HYDROCHLORIDE

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      SOUTHWEST SYNTHETIC P...
      Inactive
      15163
      N/A
      2000-11-28
      II
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      DAPTOMYCIN

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      CHONGQING DAXIN PHARM...
      Active
      35241
      N/A
      2020-09-23
      II
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      DAPTOMYCIN, NON-STERILE, BULK DRUG

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      CHONGQING DAXIN PHARM...
      Active
      29760
      Complete
      2015-12-04
      2015-09-30
      2015-11-12
      II
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        KETOPROFEN USP XXII

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        SOUTHWEST SYNTHETIC P...
        Inactive
        8416
        N/A
        1990-02-01
        II
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        LOVASTATIN

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        CHONGQING DAXIN PHARM...
        Active
        20061
        N/A
        2006-12-19
        II
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        LOVASTATIN

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        CHONGQING DAXIN PHARM...
        Active
        35431
        N/A
        2020-12-11
        II
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        LOVASTATIN, USP

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        CHONGQING DAXIN PHARM...
        Inactive
        12496
        N/A
        1997-05-08
        II
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          MECLIZINE HYDROCHLORIDE

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          SOUTHWEST SYNTHETIC P...
          Active
          19419
          N/A
          2006-04-28
          II
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          MEVASTATIN

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          CHONGQING DAXIN PHARM...
          Active
          28531
          N/A
          2014-07-31
          II
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          MYCOPHENOLATE MOFETIL

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          CHONGQING DAXIN PHARM...
          Active
          36449
          Complete
          2023-08-23
          2023-07-11
          2021-12-01
          II
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          MYCOPHENOLATE MOFETIL, NON-STERILE ...

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          CHONGQING DAXIN PHARM...
          Inactive
          20758
          N/A
          2007-08-07
          II
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          MYCOPHENOLATE SODIUM

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          CHONGQING DAXIN PHARM...
          Active
          37876
          N/A
          2023-02-20
          II
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          MYCOPHENOLIC ACID

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          CHONGQING DAXIN PHARM...
          Active
          20452
          N/A
          2007-04-17
          II
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            NABUMETONE USP

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            SOUTHWEST SYNTHETIC P...
            Active
            18581
            Complete
            2014-07-08
            2013-05-03
            2005-06-24
            II
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              SIMVASTATIN AMMONIUM SALT

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              SOUTHWEST SYNTHETIC P...
              Inactive
              24967
              N/A
              2011-04-29
              II
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                SIMVASTATIN USP

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                SOUTHWEST SYNTHETIC P...
                Active
                23425
                Complete
                2014-08-18
                2013-09-23
                2009-12-29
                II
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                SIROLIMUS

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                CHONGQING DAXIN PHARM...
                Active
                31052
                N/A
                2016-10-05
                II
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                  SULFADIAZINE

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                  SOUTHWEST SYNTHETIC P...
                  Inactive
                  22692
                  N/A
                  2009-04-02
                  II
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                    SULFAMETHOXAZOLE USP

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                    SOUTHWEST SYNTHETIC P...
                    Active
                    6793
                    N/A
                    1987-01-20
                    II
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                    TOBRAMYCIN FORM-1 USP

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                    CHONGQING DAXIN PHARM...
                    Active
                    19506
                    N/A
                    2006-06-07
                    II
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                    TOBRAMYCIN USP

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                    CHONGQING DAXIN PHARM...
                    Active
                    13774
                    Complete
                    2013-04-02
                    2013-03-26
                    1998-09-01
                    II
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                      TRIMETHOPRIM USP

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                      SOUTHWEST SYNTHETIC P...
                      Active
                      6795
                      N/A
                      1987-01-20
                      II
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                      • FDA
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                      VANCOMYCIN HYDROCHLORIDE

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                      CHONGQING DAXIN PHARM...
                      Active
                      24185
                      Complete
                      2014-02-12
                      2013-06-13
                      2010-09-17
                      II
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