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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Chunghwa Chemical Synthesis & Biotech to the U.S. FDA. Original Data : FDA Website

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    Chunghwa Chemical Synthesis & Biotech
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    1 Tung-Hsing St., Shu-Lin 23850, New Taipei City, Taiwan
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    886-2-8684-3318
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    • FDA
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    ACETAMINOPHEN USP XX PWD & ACETAMIN...

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    5061
    N/A
    1983-08-22
    II
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    BARICITINIB

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    CHUNGHWA CHEMICAL SYN...
    Active
    36030
    N/A
    2021-08-04
    II
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    CALCIUM POLYCARBOPHIL USP 23

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    14421
    N/A
    1999-10-04
    II
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    CARFILZOMIB

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    CHUNGHWA CHEMICAL SYN...
    Active
    31276
    N/A
    2016-12-30
    II
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    CARISOPRODOL

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    17400
    N/A
    2004-05-19
    II
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    CASPOFUNGIN ACETATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    27585
    N/A
    2013-11-27
    II
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    DEXBROMPHENIRAMINE MALEATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    8625
    N/A
    1990-06-28
    II
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    ESLICARBAZEPINE ACETATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    39312
    N/A
    2023-12-28
    II
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    ETHYL ICOSAPENTATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    26271
    Complete
    2013-04-01
    2012-11-20
    2012-08-01
    II
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    • FDA
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    EVEROLIMUS B02 USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    38111
    N/A
    2023-03-10
    II
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    EVEROLIMUS PRE-MIX USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    26819
    Complete
    2013-09-11
    2013-03-14
    2013-02-08
    II
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    EVEROLIMUS USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    27216
    Complete
    2013-10-04
    2013-08-05
    2013-07-01
    II
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    FAVIPIRAVIR

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    CHUNGHWA CHEMICAL SYN...
    Active
    35849
    N/A
    2021-06-17
    II
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    FLUCONAZOLE

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    14419
    N/A
    1999-09-23
    II
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    GLYBURIDE USP

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    18266
    N/A
    2005-04-11
    II
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    GUAIFENESIN USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    14234
    Complete
    2016-05-24
    2016-03-24
    1999-06-24
    II
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    LOVASTATIN

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    17498
    N/A
    2004-06-23
    II
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    METAXALONE USP

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    23434
    N/A
    2010-01-06
    II
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    METHOCARBAMOL USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    13080
    Complete
    2013-03-28
    2013-03-18
    1998-07-17
    II
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    MIDOSTAURIN

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    CHUNGHWA CHEMICAL SYN...
    Active
    36640
    N/A
    2021-12-29
    II
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    • FDA
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    MYCOPHENOLATE MOFETIL HYDROCHLORIDE...

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    CHUNGHWA CHEMICAL SYN...
    Active
    24372
    N/A
    2010-11-15
    II
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    MYCOPHENOLATE MOFETIL USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    18494
    Complete
    2017-02-01
    2016-11-22
    2005-07-11
    II
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    MYCOPHENOLATE MOFETIL USP (PROCESS ...

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    CHUNGHWA CHEMICAL SYN...
    Active
    33333
    Complete
    2019-02-01
    2018-12-04
    2018-12-07
    II
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    MYCOPHENOLATE SODIUM

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    23435
    N/A
    2010-01-06
    II
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    MYCOPHENOLATE SODIUM USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    35848
    N/A
    2021-06-24
    II
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    OLOPATADINE HCL

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    22430
    N/A
    2009-01-07
    II
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    • FDA
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    OMEGA-3-CARBOXYLIC ACIDS

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    CHUNGHWA CHEMICAL SYN...
    Inactive
    30103
    N/A
    2016-05-09
    II
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    OZANIMOD HYDROCHLORIDE

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    CHUNGHWA CHEMICAL SYN...
    Active
    37597
    N/A
    2022-10-21
    II
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    PALBOCICLIB

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    CHUNGHWA CHEMICAL SYN...
    Active
    37586
    N/A
    2022-11-01
    II
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    PRAVASTATIN SODIUM USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    14235
    N/A
    1999-06-24
    II
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    RAPAMYCIN

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    CHUNGHWA CHEMICAL SYN...
    Active
    17399
    N/A
    2004-05-20
    II
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    RAPAMYCIN (SIROLIMUS)

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    CHUNGHWA CHEMICAL SYN...
    Active
    31189
    Complete
    2017-03-03
    2017-01-04
    2016-12-30
    II
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    RIBOCICLIB SUCCINATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    36174
    N/A
    2021-11-30
    II
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    TACROLIMUS

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    CHUNGHWA CHEMICAL SYN...
    Active
    18985
    Complete
    2016-04-01
    2016-03-09
    2005-11-28
    II
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    TACROLIMUS (PROCESS B)

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    CHUNGHWA CHEMICAL SYN...
    Active
    38310
    N/A
    2023-04-26
    II
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    TACROLIMUS SD20

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    CHUNGHWA CHEMICAL SYN...
    Active
    23213
    N/A
    2009-10-26
    II
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    • FDA
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    TOFACITINIB CITRATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    37532
    N/A
    2022-10-28
    II
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    TRANDOLAPRIL USP

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    CHUNGHWA CHEMICAL SYN...
    Active
    17573
    N/A
    2004-07-27
    II
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    DIFELIKEFALIN ACETATE

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    CHUNGHWA CHEMICAL SYN...
    Active
    38511
    N/A
    2023-06-19
    II
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