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

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    Hikal
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    APIXABAN

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    2017-12-29
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    BUPROPION HYDROBROMIDE (FORM II)

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    38384
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    2023-05-29
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    BUPROPION HYDROBROMIDE (FORM-I)

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    HIKAL LTD
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    38231
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    2023-03-24
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    BUPROPION HYDROCHLORIDE USP

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    HIKAL LTD
    Active
    16476
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    2014-02-07
    2014-01-31
    2003-03-13
    II
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    BUPROPION HYDROCHLORIDE USP [PROCES...

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    HIKAL LTD
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    28421
    N/A
    2014-06-21
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    BUTORPHANOL TARTRATE USP

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    HIKAL LTD
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    31875
    Complete
    2022-04-26
    2022-04-18
    2017-06-29
    II
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    CELECOXIB

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    HIKAL LTD
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    31971
    N/A
    2017-07-29
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    DABIGATRAN ETEXILATE MESYLATE

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    HIKAL LTD
    Inactive
    31613
    N/A
    2017-03-25
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    DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPAN...

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    32571
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    2018-04-30
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    DESVENLAFAXINE SUCCINATE USP

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    HIKAL LTD
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    37426
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    2022-08-20
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    DONEPEZIL HYDROCHLORIDE API

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    HIKAL LTD
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    27611
    N/A
    2013-09-30
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    EMPAGLIFLOZIN

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    HIKAL LTD
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    32570
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    2018-09-12
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    ERTUGLIFLOZIN L-PYROGLUTAMIC ACID

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    HIKAL LTD
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    34850
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    2020-05-01
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    FAVIPIRAVIR

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    35783
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    2021-03-27
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    GABAPENTIN USP

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    HIKAL LTD
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    16060
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    2013-01-18
    2012-12-14
    2002-07-24
    II
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    GABEPENTIN (A01804)

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    HIKAL LTD
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    28335
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    2014-05-24
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    GEIBROZIL API

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    HIKAL LTD
    Active
    18815
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    2013-05-21
    2012-12-14
    2005-09-15
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    LACOSAMIDE USP

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    HIKAL LTD
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    30345
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    2021-10-14
    2021-07-20
    2016-02-25
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    LEVETIRACETAM API

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    HIKAL LTD
    Inactive
    19104
    N/A
    2006-01-10
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    MEMANTINE HYDROCHLORIDE USP

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    HIKAL LTD
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    23567
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    2014-07-29
    2014-01-21
    2010-02-22
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    OLMESARTAN MEDOXOMIL USP

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    HIKAL LTD
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    30433
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    2016-03-22
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    ONDANSETRON HYDROCHLORIDE USP

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    HIKAL LTD
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    16710
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    2021-08-17
    2021-08-12
    2003-07-15
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    ONDANSETRON USP

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    HIKAL LTD
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    18829
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    2021-08-17
    2021-08-12
    2005-09-03
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    PENTOXIFYLLINE USP

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    HIKAL LTD
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    14182
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    2020-09-15
    2020-07-09
    1999-06-01
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    PREGABALIN (PROCESS-II)

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    HIKAL LTD
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    29688
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    2015-08-12
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    PREGABALIN USP

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    HIKAL LTD
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    28663
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    2018-01-18
    2017-12-06
    2014-09-19
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    QUETIAPINE FUMARATE (PROCESS-B) USP

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    HIKAL LTD
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    24087
    Complete
    2018-01-19
    2017-12-07
    2010-08-18
    II
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    RIVAROXABAN USP

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    HIKAL LTD
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    38708
    N/A
    2023-08-18
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    SITAGLIPTIN HYDROCHLORIDE (PROCESS ...

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    HIKAL LTD
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    37288
    N/A
    2022-06-30
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    SITAGLIPTIN PHOSPHATE ANHYDRATE

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    HIKAL LTD
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    34734
    N/A
    2020-03-28
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    SITAGLIPTIN PHOSPHATE MONOHYDRATE (...

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    HIKAL LTD
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    31579
    Complete
    2024-02-23
    2024-01-08
    2017-03-17
    II
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    TRIPROLIDINE HYDROCHLORIDE USP

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    HIKAL LTD
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    19019
    N/A
    2005-12-08
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    VALACYCLOVIR HYDROCHLORIDE USP

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    HIKAL LTD
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    30456
    N/A
    2016-03-29
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    VENLAFAXINE BASE

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    HIKAL LTD
    Inactive
    28025
    N/A
    2014-02-18
    II
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    VENLAFAXINE HYDROCHLORIDE USP

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    HIKAL LTD
    Active
    22956
    Complete
    2014-01-10
    2013-05-22
    2009-07-18
    II
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    VILDAGLIPTIN

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    HIKAL LTD
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    29933
    N/A
    2015-10-14
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