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

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    01 ABROCITINIB (1)

    02 AGOMELATINE (2)

    03 ALISKIREN HEMIFUMARATE (1)

    04 APIXABAN (1)

    05 APREMILAST (1)

    06 ATORVASTATIN CALCIUM (TRIHYDRATE) (1)

    07 BALOXAVIR MARBOXIL (1)

    08 CANAGLIFLOZIN HEMIHYDRATE (1)

    09 CAPTOPRIL (1)

    10 CRISABOROLE (1)

    11 DABIGATRAN ETEXILATE MESYLATE (1)

    12 DOXYCYCLINE (1)

    13 DOXYCYCLINE (ROUTE CODE: DX) (1)

    14 DOXYCYCLINE HYCLATE (1)

    15 ELAGOLIX SODIUM (1)

    16 ELTROMBOPAG OLAMINE (1)

    17 EZETIMIBE (1)

    18 EZETIMIBE (ROUTE CODE: ZT) (1)

    19 FACILITY FOR THE MANUFACTURE OF METHACYCLINE (1)

    20 HYDROCHLOROTHIAZIDE (2)

    21 LCZ-9 (SACUBITRIL INTERMEDIATE) (1)

    22 LENALIDOMIDE (1)

    23 OBETICHOLIC ACID (1)

    24 POMALIDOMIDE (1)

    25 PREGABALIN (1)

    26 PREGABALIN (ROUTE CODE:PR) (1)

    27 RELUGOLIX (1)

    28 RIMEGEPANT SULFATE (1)

    29 RIVAROXABAN (1)

    30 ROSUVASTATIN CALCIUM (1)

    31 ROSUVASTATIN CALCIUM (ROUTE CODE: RSF) (1)

    32 RSM (ROSUVASTATIN METHYL ESTER, ROSUVASTATIN CALCIUM INTERMEDIATE) (1)

    33 SACUBITRIL SODIUM (1)

    34 SACUBITRIL VALSARTAN SODIUM (1)

    35 SOFOSBUVIR (AMORPHOUS) (1)

    36 SUGAMMADEX SODIUM (1)

    37 TICAGRELOR (1)

    38 TICAGRELOR (ROUTE CODE: TG) (1)

    39 TOFACITINIB CITRATE (1)

    40 VENETOCLAX (1)

    41 VERICIGUAT (1)

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    01 CHANGZHOU PHARMACEUTICAL FACTORY (43)

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    01 China (43)

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    01 Active (39)

    02 Inactive (4)

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    01 Complete (19)

    02 Blank (24)

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    ABROCITINIB

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    CHANGZHOU PHARMACEUTI...
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    2023-12-27
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    AGOMELATINE

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    CHANGZHOU PHARMACEUTI...
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    38958
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    2023-09-27
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    AGOMELATINE

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    CHANGZHOU PHARMACEUTI...
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    26965
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    2013-03-08
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    ALISKIREN HEMIFUMARATE

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    CHANGZHOU PHARMACEUTI...
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    24755
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    2011-03-10
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    APIXABAN

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    CHANGZHOU PHARMACEUTI...
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    37883
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    2022-12-27
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    APREMILAST

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    CHANGZHOU PHARMACEUTI...
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    37882
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    2022-12-27
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    ATORVASTATIN CALCIUM (TRIHYDRATE)

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    CHANGZHOU PHARMACEUTI...
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    29057
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    2015-07-13
    2015-02-11
    2015-02-03
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    BALOXAVIR MARBOXIL

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    CHANGZHOU PHARMACEUTI...
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    36657
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    2022-04-06
    2022-02-25
    2021-12-31
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    CANAGLIFLOZIN HEMIHYDRATE

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    CHANGZHOU PHARMACEUTI...
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    36739
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    2022-01-27
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    CAPTOPRIL

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    CHANGZHOU PHARMACEUTI...
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    33888
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    2019-08-15
    2019-06-20
    2019-05-22
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