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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by CSPC Pharmaceutical Group to the U.S. FDA. Original Data : FDA Website

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    CSPC Pharmaceutical Group
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    China
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    No.896 Zhongshan East Road,Shijiazhuang, Hebei Province,PRC 050035
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    +86 31187037015
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    enquiries@pharmacompass.com
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    6 APA (6-AMINO-PENICILLIC ACID)

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    17197
    N/A
    2004-02-22
    II
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    6-AMINO-PENICILLANIC ACID (BY DIREC...

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    22393
    N/A
    2008-12-31
    II
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    7-AMINOCEPHALOSPORANIC ACID

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    CSPC HEBEI ZHONGRUN P...
    Inactive
    20842
    N/A
    2007-08-30
    II
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    7-AMINOCEPHALOSPORANIC ACID 7-ACA

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    16299
    N/A
    2002-12-10
    II
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    ACARBOSE

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    HEBEI HUARONG PHARMAC...
    Active
    25207
    N/A
    2011-07-11
    II
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    ACARBOSE

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    CSPC SHENGXUE GLUCOSE...
    Active
    35603
    N/A
    2021-03-01
    II
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    ALENDRONATE SODIUM USP 28

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    SHIJIAZHUANG PHARMACE...
    Inactive
    18577
    N/A
    2005-06-06
    II
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    AMOXICILLIN

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    17324
    N/A
    2004-04-19
    II
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    AMPICILLIN TRIHYDRATE

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    25035
    N/A
    2011-05-09
    II
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    ASCORBIC ACID (VITAMIN C)

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    CSPC WEISHENG PHARMAC...
    Active
    23162
    Complete
    2018-04-19
    2018-03-22
    2009-10-07
    II
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    AZAERYTHROMYCIN

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    CSPC OUYI PHARMACEUTI...
    Active
    33820
    N/A
    2019-05-09
    II
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    AZITHROMYCIN

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    CSPC OUYI PHARMACEUTI...
    Active
    22331
    Complete
    2014-05-16
    2014-05-07
    2008-12-05
    II
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    AZITHROMYCIN USP (API)

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    SHIJIAZHUANG PHARMACE...
    Inactive
    20074
    N/A
    2006-12-18
    II
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    CEFAZOLIN SODIUM (STERILE)

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    24527
    N/A
    2011-01-04
    II
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    CEFIXIME NON-STERILE

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    25390
    N/A
    2011-09-30
    II
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    CEFOTAXIME SODIUM STERILE

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    24892
    N/A
    2011-04-18
    II
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    CEFTRIAXONE SODIUM (NON-STERILE)

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    24160
    N/A
    2010-08-31
    II
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    CEFTRIAXONE SODIUM STERILE

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    25381
    N/A
    2011-09-05
    II
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    COBAMAMIDE

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    HEBEI HUARONG PHARMAC...
    Active
    22976
    N/A
    2009-04-21
    II
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    CYANOCOBALAMIN

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    HEBEI HUARONG PHARMAC...
    Active
    36191
    N/A
    2021-08-30
    II
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    CYANOCOBALAMIN

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    HEBEI HUARONG PHARMAC...
    Inactive
    20973
    N/A
    2007-10-25
    II
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    HYDROXOCOBALAMIN ACETATE

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    HEBEI HUARONG PHARMAC...
    Active
    27229
    N/A
    2013-06-04
    II
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    INDOMETHACIN

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    CSPC OUYI PHARMACEUTI...
    Active
    21984
    N/A
    2008-09-16
    II
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    MECOBALAMIN

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    HEBEI HUARONG PHARMAC...
    Active
    20259
    N/A
    2007-01-08
    II
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    MECOBALAMIN

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    HEBEI HUARONG PHARMAC...
    Active
    36190
    N/A
    2021-08-30
    II
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    PENICILLIN G POTASSIUM

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    SHIJIAZHUANG PHARMA G...
    Inactive
    16106
    N/A
    2002-08-21
    II
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    PENICILLIN G POTASSIUM (NON-STERILE...

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    CSPC ZHONGNUO PHARMAC...
    Inactive
    24826
    N/A
    2011-03-21
    II
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    SODIUM ASCORBATE

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    CSPC WEISHENG PHARMAC...
    Active
    23686
    Complete
    2019-05-29
    2018-03-22
    2010-04-03
    II
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    TRAMADOL HYDROCHLORIDE

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    CSPC OUYI PHARMACEUTI...
    Active
    21805
    Complete
    2018-07-13
    2018-06-11
    2008-07-15
    II
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    TRAMADOL HYDROCHLORIDE EP

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    SHIJIAZHUANG PHARMACE...
    Inactive
    18578
    N/A
    2005-04-29
    II
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