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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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    01 ALLOPURINOL (1)

    02 AMIKACIN BASE (1)

    03 AMIKACIN HYDROCHLORIDE, NON-STERILE BULK DRUG (1)

    04 AMIKACIN SULFATE (1:2) USP (1)

    05 Amikacin Sulfate (1:1.8) USP, Non-Sterile Bulk Drug Substance (1)

    06 BUSPIRONE HYDROCHLORIDE (1)

    07 DAPTOMYCIN (1)

    08 DAPTOMYCIN, NON-STERILE, BULK DRUG (1)

    09 KETOPROFEN USP XXII (1)

    10 LOVASTATIN (2)

    11 LOVASTATIN, USP (1)

    12 MECLIZINE HYDROCHLORIDE (1)

    13 MEVASTATIN (1)

    14 MYCOPHENOLATE MOFETIL (1)

    15 MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCE (1)

    16 MYCOPHENOLATE SODIUM (1)

    17 MYCOPHENOLIC ACID (1)

    18 NABUMETONE USP (1)

    19 SIMVASTATIN AMMONIUM SALT (1)

    20 SIMVASTATIN USP (1)

    21 SIROLIMUS (1)

    22 SULFADIAZINE (1)

    23 SULFAMETHOXAZOLE USP (1)

    24 TOBRAMYCIN FORM-1 USP (1)

    25 TOBRAMYCIN USP (1)

    26 TRIMETHOPRIM USP (1)

    27 VANCOMYCIN HYDROCHLORIDE (1)

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    01 CHONGQING DAXIN PHARMACEUTICAL CO LTD (16)

    02 PKU HEALTHCARE CORP LTD (1)

    03 PKUCARE CHONGQING DAXIN PHARMACEUTICAL CO LTD (2)

    04 SOUTHWEST SYNTHETIC PHARMACEUTICAL CO LTD (2)

    05 SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD (6)

    06 SOUTHWEST SYNTHETIC PHARMACEUTICAL GENERAL FACTORY (1)

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    01 China (28)

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    01 Active (17)

    02 Inactive (11)

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    01 Complete (6)

    02 Blank (22)

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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
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      DAPTOMYCIN

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      CHONGQING DAXIN PHARM...
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      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...
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        8416
        N/A
        1990-02-01
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        LOVASTATIN

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