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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Standard Chem. & Pharm. Co., Ltd to the U.S. FDA. Original Data : FDA Website

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    STANDARD CHEM. & PHARM. CO., LTD

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    Standard Chem. & Pharm. Co., Ltd
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    China
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    Address
    No.6-20, Tuku., Tuku Village, Sinying District, Tainan City 73055
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    +886 06-636-1516
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    enquiries@pharmacompass.com
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    https://www.standard.com.tw/
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    • FDA
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    ALFUZOSIN HYDROCHLORIDE

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    STANDARD CHEM AND PHA...
    Inactive
    19786
    N/A
    2006-12-01
    II
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    ATENOLOL USP

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    SYN-TECH CHEM AND PHA...
    Inactive
    21617
    N/A
    2008-05-12
    II
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    CHLORZOXAZONE USP

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    SYN-TECH CHEM AND PHA...
    Active
    8736
    Complete
    2014-03-06
    2014-02-25
    1990-09-13
    II
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    CROTAMITON USP

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    SYN-TECH CHEM AND PHA...
    Active
    26374
    N/A
    2012-08-29
    II
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    DEXTROMETHORPHAN HYDROBROMIDE USP

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    STANDARD CHEM AND PHA...
    Inactive
    13854
    N/A
    1998-10-16
    II
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    DICLOFENAC EPOLAMINE

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    SYN-TECH CHEM AND PHA...
    Active
    24962
    Complete
    2015-03-03
    2014-04-30
    2011-05-05
    II
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    DICLOFENAC POTASSIUM USP

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    SYN-TECH CHEM AND PHA...
    Active
    12656
    N/A
    1997-09-10
    II
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    DICLOFENAC SODIUM USP

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    SYN-TECH CHEM AND PHA...
    Active
    9899
    Complete
    2013-04-10
    2013-03-27
    1992-10-05
    II
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    DILTIAZEM HYDROCHLORIDE USP

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    SYN-TECH CHEM AND PHA...
    Inactive
    14659
    N/A
    2000-01-06
    II
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    DOXAZOSIN MESYLATE

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    STANDARD CHEM AND PHA...
    Inactive
    20770
    N/A
    2007-08-06
    II
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    ENTACAPONE

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    STANDARD CHEM AND PHA...
    Inactive
    23804
    N/A
    2010-05-11
    II
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    GRANISETRON

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    SYN-TECH CHEM AND PHA...
    Active
    25980
    Complete
    2015-06-29
    2015-03-20
    2012-04-16
    II
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    GRANISETRON HYDROCHLORIDE USP

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    SYN-TECH CHEM AND PHA...
    Active
    26504
    N/A
    2012-09-26
    II
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    LAMOTRIGINE USP

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    SYN-TECH CHEM AND PHA...
    Active
    30270
    N/A
    2016-02-02
    II
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    LANSOPRAZOLE USP

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    SYN-TECH CHEM AND PHA...
    Active
    19537
    N/A
    2006-06-14
    II
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    LIDOCAINE USP

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    SYN-TECH CHEM AND PHA...
    Inactive
    18005
    N/A
    2005-01-10
    II
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      LOVASTATIN

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      SYNGEN BIOTECH CO LTD
      Inactive
      12481
      N/A
      1997-04-25
      II
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      METAXALONE USP

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      SYN-TECH CHEM AND PHA...
      Active
      24631
      Complete
      2014-06-16
      2014-03-06
      2011-02-04
      II
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      METOPROLOL SUCCINATE USP

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      SYN-TECH CHEM AND PHA...
      Inactive
      15966
      N/A
      2002-04-29
      II
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      MIRTAZAPINE USP

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      SYN-TECH CHEM AND PHA...
      Active
      29748
      N/A
      2015-08-31
      II
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        MUPIROCIN

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        SYNGEN BIOTECH CO LTD
        Active
        30292
        N/A
        2016-02-11
        II
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        NAFTOPIDIL

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        SYN-TECH CHEM AND PHA...
        Active
        26502
        N/A
        2012-09-26
        II
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        • FDA
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        PHENYLEPHRINE HYDROCHLORIDE USP

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        SYN-TECH CHEM AND PHA...
        Active
        18319
        Complete
        2013-05-09
        2013-04-30
        2005-05-06
        II
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        PHENYLTOLOXAMINE CITRATE USP

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        SYN-TECH CHEM AND PHA...
        Inactive
        18955
        N/A
        2005-11-08
        II
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        PRAMOXINE HYDROCHLORIDE, USP

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        SYN-TECH CHEM AND PHA...
        Active
        15464
        Complete
        2017-03-24
        2016-08-04
        2001-05-25
        II
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        PRAZOSIN HYDROCHLORIDE

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        STANDARD CHEM AND PHA...
        Inactive
        18234
        N/A
        2005-03-28
        II
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        • FDA
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        RABEPRAZOLE SODIUM

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        SYN-TECH CHEM AND PHA...
        Active
        23400
        N/A
        2009-12-15
        II
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        RILUZOLE

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        SYN TECH CHEM AND PHA...
        Active
        26147
        Complete
        2014-02-07
        2013-04-08
        2012-06-08
        II
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        RIZATRIPTAN BENZOATE USP

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        SYN-TECH CHEM AND PHA...
        Active
        28634
        N/A
        2014-09-08
        II
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        • FDA
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        TERAZOSIN HYDROCHLORIDE

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        STANDARD CHEM AND PHA...
        Inactive
        20025
        N/A
        2006-10-31
        II
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        • FDA
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        THEOPHYLLINE SODIUM GLYCINATE

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        STANDARD CHEM AND PHA...
        Inactive
        18896
        N/A
        2005-10-17
        II
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        • FDA
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        TIMOLOL MALEATE (TMM)

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        SYN-TECH CHEM AND PHA...
        Active
        36428
        Complete
        2023-08-31
        2023-06-27
        2022-06-16
        II
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        TIMOLOL MALEATE USP

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        SYN-TECH CHEM AND PHA...
        Active
        23009
        Complete
        2015-01-24
        2014-05-28
        2009-07-31
        II
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        • FDA
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        TOLPERISONE HYDROCHLORIDE

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        SYN-TECH CHEM AND PHA...
        Active
        25466
        N/A
        2011-10-31
        II
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        • FDA
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        ZOLMITRIPTAN

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        SYN-TECH CHEM AND PHA...
        Active
        27818
        N/A
        2013-12-11
        II
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          MANUFACTURING SITE, FACILITIES, PER...

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          SYNGEN BIOTECH CO LTD
          Inactive
          13853
          N/A
          1998-10-16
          II
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