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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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    Changzhou Pharmaceutical Factory
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    NO. 518 Laodong East Road, Changzhou, Jiangsu, 213018 China
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    ABROCITINIB

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    CHANGZHOU PHARMACEUTI...
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    39291
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    2023-12-27
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    AGOMELATINE

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    CHANGZHOU PHARMACEUTI...
    Active
    38958
    N/A
    2023-09-27
    II
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    AGOMELATINE

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    CHANGZHOU PHARMACEUTI...
    Inactive
    26965
    N/A
    2013-03-08
    II
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    ALISKIREN HEMIFUMARATE

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    CHANGZHOU PHARMACEUTI...
    Inactive
    24755
    N/A
    2011-03-10
    II
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    APIXABAN

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    CHANGZHOU PHARMACEUTI...
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    37883
    N/A
    2022-12-27
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    APREMILAST

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

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    CHANGZHOU PHARMACEUTI...
    Active
    29057
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    2015-07-13
    2015-02-11
    2015-02-03
    II
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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
    N/A
    2022-01-27
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    CAPTOPRIL

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

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    CHANGZHOU PHARMACEUTI...
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    37356
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    2022-07-28
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    DABIGATRAN ETEXILATE MESYLATE

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    CHANGZHOU PHARMACEUTI...
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    37528
    N/A
    2022-11-03
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    DOXYCYCLINE

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    CHANGZHOU PHARMACEUTI...
    Active
    18959
    Complete
    2014-05-26
    2014-05-14
    2005-11-09
    II
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    DOXYCYCLINE HYCLATE

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    CHANGZHOU PHARMACEUTI...
    Active
    13771
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    2013-08-07
    2013-07-29
    1998-09-01
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    ELAGOLIX SODIUM

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    CHANGZHOU PHARMACEUTI...
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    36738
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    2022-01-27
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    ELTROMBOPAG OLAMINE

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    CHANGZHOU PHARMACEUTI...
    Active
    37134
    N/A
    2022-05-31
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    EZETIMIBE

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    CHANGZHOU PHARMACEUTI...
    Active
    24511
    Complete
    2015-04-03
    2013-09-27
    2010-12-30
    II
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    EZETIMIBE (ROUTE CODE: ZT)

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    CHANGZHOU PHARMACEUTI...
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    35963
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    2023-07-03
    2023-05-18
    2021-05-27
    II
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    FACILITY FOR THE MANUFACTURE OF MET...

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    CHANGZHOU PHARMACEUTI...
    Inactive
    9783
    N/A
    1992-06-19
    II
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    HYDROCHLOROTHIAZIDE

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    CHANGZHOU PHARMACEUTI...
    Active
    16750
    Complete
    2013-10-05
    2013-09-27
    2003-08-08
    II
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    HYDROCHLOROTHIAZIDE

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    CHANGZHOU PHARMACEUTI...
    Inactive
    4924
    N/A
    1983-04-29
    II
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    LCZ-9 (SACUBITRIL INTERMEDIATE)

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    CHANGZHOU PHARMACEUTI...
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    33525
    N/A
    2019-01-23
    II
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    LENALIDOMIDE

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    CHANGZHOU PHARMACEUTI...
    Active
    31804
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    2017-09-01
    2017-06-19
    2017-06-02
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    OBETICHOLIC ACID

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    CHANGZHOU PHARMACEUTI...
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    37355
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    2023-02-15
    2023-01-17
    2022-08-15
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    POMALIDOMIDE

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    CHANGZHOU PHARMACEUTI...
    Active
    39069
    N/A
    2023-10-26
    II
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    PREGABALIN

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    CHANGZHOU PHARMACEUTI...
    Active
    22223
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    2013-10-07
    2013-09-27
    2008-11-24
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    RELUGOLIX

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    CHANGZHOU PHARMACEUTI...
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    39161
    N/A
    2023-12-27
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    RIMEGEPANT SULFATE

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    CHANGZHOU PHARMACEUTI...
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    38655
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    2023-09-25
    2023-08-24
    2023-08-14
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    RIVAROXABAN

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    CHANGZHOU PHARMACEUTI...
    Active
    34436
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    2020-04-17
    2020-03-10
    2019-12-26
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    ROSUVASTATIN CALCIUM

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    CHANGZHOU PHARMACEUTI...
    Active
    20705
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    2013-10-05
    2013-09-27
    2007-07-18
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    ROSUVASTATIN CALCIUM (ROUTE CODE: R...

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    CHANGZHOU PHARMACEUTI...
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    34974
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    2020-08-04
    2020-07-13
    2020-07-03
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    RSM (ROSUVASTATIN METHYL ESTER, ROS...

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    CHANGZHOU PHARMACEUTI...
    Active
    23223
    N/A
    2009-10-29
    II
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    SACUBITRIL SODIUM

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    CHANGZHOU PHARMACEUTI...
    Active
    35962
    N/A
    2021-05-31
    II
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    SACUBITRIL VALSARTAN SODIUM

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    CHANGZHOU PHARMACEUTI...
    Active
    35480
    N/A
    2020-12-28
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    SOFOSBUVIR (AMORPHOUS)

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    CHANGZHOU PHARMACEUTI...
    Active
    32048
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    2018-01-24
    2017-09-15
    2017-09-06
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    SUGAMMADEX SODIUM

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    CHANGZHOU PHARMACEUTI...
    Active
    37085
    N/A
    2022-04-25
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    TICAGRELOR

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    CHANGZHOU PHARMACEUTI...
    Active
    28984
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    2015-06-29
    2015-01-16
    2015-01-14
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    TICAGRELOR (ROUTE CODE: TG)

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    CHANGZHOU PHARMACEUTI...
    Active
    34835
    Complete
    2020-09-15
    2020-08-12
    2020-07-31
    II
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    TOFACITINIB CITRATE

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    CHANGZHOU PHARMACEUTI...
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    35746
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    2021-10-26
    2021-09-16
    2021-03-31
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    VENETOCLAX

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    CHANGZHOU PHARMACEUTI...
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    39289
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    2023-12-29
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    VERICIGUAT

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    CHANGZHOU PHARMACEUTI...
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    37984
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    2023-02-27
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    DOXYCYCLINE (ROUTE CODE: DX)

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    39292
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    2023-12-22
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    PREGABALIN (ROUTE CODE:PR)

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    39164
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    2023-11-30
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