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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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    01 ACETAMINOPHEN USP XX PWD & ACETAMINOPHEN W/10% STARCH (1)

    02 BARICITINIB (1)

    03 CALCIUM POLYCARBOPHIL USP 23 (1)

    04 CARFILZOMIB (1)

    05 CARISOPRODOL (1)

    06 CASPOFUNGIN ACETATE (1)

    07 DEXBROMPHENIRAMINE MALEATE (1)

    08 DIFELIKEFALIN ACETATE (1)

    09 ESLICARBAZEPINE ACETATE (1)

    10 ETHYL ICOSAPENTATE (1)

    11 EVEROLIMUS B02 USP (1)

    12 EVEROLIMUS PRE-MIX USP (1)

    13 EVEROLIMUS USP (1)

    14 FAVIPIRAVIR (1)

    15 FLUCONAZOLE (1)

    16 GLYBURIDE USP (1)

    17 GUAIFENESIN USP (1)

    18 LOVASTATIN (1)

    19 METAXALONE USP (1)

    20 METHOCARBAMOL USP (1)

    21 MIDOSTAURIN (1)

    22 MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANHYDROUS (1)

    23 MYCOPHENOLATE MOFETIL USP (1)

    24 MYCOPHENOLATE MOFETIL USP (PROCESS B) (1)

    25 MYCOPHENOLATE SODIUM (1)

    26 MYCOPHENOLATE SODIUM USP (1)

    27 OLOPATADINE HCL (1)

    28 OMEGA-3-CARBOXYLIC ACIDS (1)

    29 OZANIMOD HYDROCHLORIDE (1)

    30 PALBOCICLIB (1)

    31 PRAVASTATIN SODIUM USP (1)

    32 RAPAMYCIN (1)

    33 RAPAMYCIN (SIROLIMUS) (1)

    34 RIBOCICLIB SUCCINATE (1)

    35 TACROLIMUS (1)

    36 TACROLIMUS (PROCESS B) (1)

    37 TACROLIMUS SD20 (1)

    38 TOFACITINIB CITRATE (1)

    39 TRANDOLAPRIL USP (1)

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    01 CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD (39)

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    ACETAMINOPHEN USP XX PWD & ACETAMIN...

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

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    CHUNGHWA CHEMICAL SYN...
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    36030
    N/A
    2021-08-04
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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...
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    31276
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    2016-12-30
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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...
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    27585
    N/A
    2013-11-27
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    DEXBROMPHENIRAMINE MALEATE

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

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    CHUNGHWA CHEMICAL SYN...
    Active
    39312
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    2023-12-28
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    ETHYL ICOSAPENTATE

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

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    CHUNGHWA CHEMICAL SYN...
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    38111
    N/A
    2023-03-10
    II
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