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

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    Alkem Laboratories
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    Devashish Building, Alkem House, Senapati Bapat Road, Lower Parel, Mumbai - 400 013
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    AMLODIPINE BENZOATE

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    ALKEM LABORATORIES LT...
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    35610
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    2021-03-31
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    AMLODIPINE BESYLATE USP

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    ALKEM LABORATORIES LT...
    Active
    29703
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    2016-03-03
    2015-10-06
    2015-09-28
    II
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    APREMILAST

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    ALKEM LABORATORIES LT...
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    32114
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    2017-11-01
    2017-10-05
    2017-10-03
    II
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    ARIPIPRAZOLE USP

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    ALKEM LABORATORIES LT...
    Active
    27909
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    2014-07-07
    2014-04-21
    2014-02-13
    II
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    AZILSARTAN KAMEDOXOMIL

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    ALKEM LABORATORIES LT...
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    38047
    N/A
    2023-09-12
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    BEMPEDOIC ACID

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    ALKEM LABORATORIES LT...
    Active
    38713
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    2023-11-01
    2023-09-22
    2023-08-31
    II
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    Bis-Boc-Lisdexaetamine

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    36325
    N/A
    2021-10-25
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    CANAGLIFLOZIN

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    30941
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    2016-12-02
    2016-09-26
    2016-09-16
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    CANNABIDIOL

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    ALKEM LABORATORIES LT...
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    36744
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    2022-03-10
    2022-02-17
    2022-02-08
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    DALFAMPRIDINE USP

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    ALKEM LABORATORIES LT...
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    27637
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    2014-01-24
    2013-11-19
    2013-11-01
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

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    ALKEM LABORATORIES LT...
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    32902
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    2018-09-10
    2018-06-28
    2018-06-23
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    DIMETHYL FUMARATE

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    ALKEM LABORATORIES LT...
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    30622
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    2016-12-02
    2016-07-25
    2016-07-26
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    DRONEDARONE HYDROCHLORIDE

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    ALKEM LABORATORIES LT...
    Active
    26901
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    2013-07-11
    2013-04-08
    2013-03-26
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    DULOXETINE HYDROCHLORIDE

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    ALKEM LABORATORIES LT...
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    24685
    N/A
    2011-03-17
    II
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    ELUXADOLINE

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    ALKEM LABORATORIES LT...
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    33372
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    2019-03-01
    2018-12-21
    2019-01-02
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    ESKETAMINE HYDROCHLORIDE

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    ALKEM LABORATORIES LT...
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    37461
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    2022-10-25
    2022-10-14
    2022-09-26
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    ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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    ALKEM LABORATORIES LT...
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    28581
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    2014-11-26
    2014-10-14
    2014-10-01
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    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...

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    ALKEM LABORATORIES LT...
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    30787
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    2016-11-04
    2016-08-30
    2016-08-17
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    LAMOTRIGINE

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    ALKEM LABORATORIES LT...
    Inactive
    21390
    N/A
    2008-03-20
    II
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    LANSOPRAZOLE USP

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    ALKEM LABORATORIES LT...
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    25152
    N/A
    2011-07-29
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    LANTHANUM CARBONATE OCTAHYDRATE

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    ALKEM LABORATORIES LT...
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    35298
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    2020-12-11
    2020-11-02
    2020-10-21
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    LISDEXAETAMINE DIMESYLATE

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    ALKEM LABORATORIES LT...
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    38667
    N/A
    2023-08-03
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    MESALAMINE USP

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    ALKEM LABORATORIES LT...
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    33939
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    2019-08-14
    2019-06-18
    2019-07-06
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    METHYLPHENIDATE HYDROCHLORIDE USP

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    ALKEM LABORATORIES LT...
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    30682
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    2016-10-30
    2016-08-03
    2016-07-29
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    N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERI...

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    ALKEM LABORATORIES LT...
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    31408
    N/A
    2017-03-20
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    OLANZAPINE USP

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    ALKEM LABORATORIES LT...
    Inactive
    24016
    N/A
    2010-08-23
    II
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    RABEPRAZOLE SODIUM USP

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    ALKEM LABORATORIES LT...
    Active
    27403
    Complete
    2015-07-24
    2015-03-20
    2013-09-01
    II
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    RASAGILINE MESYLATE

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    ALKEM LABORATORIES LT...
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    23679
    N/A
    2010-04-26
    II
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    RILUZOLE USP

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    ALKEM LABORATORIES LT...
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    25260
    N/A
    2011-09-24
    II
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    RITALINIC ACID

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    ALKEM LABORATORIES LT...
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    36599
    N/A
    2021-12-21
    II
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    RIZATRIPTAN BENZOATE USP

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    ALKEM LABORATORIES LT...
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    24884
    N/A
    2011-05-06
    II
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    SODIUM OXYBATE

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    ALKEM LABORATORIES LT...
    Active
    28289
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    2022-10-06
    2022-08-17
    2014-06-19
    II
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    Solriaetol Hydrochloride

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    ALKEM LABORATORIES LT...
    Active
    36951
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    2023-02-15
    2023-02-03
    2022-03-28
    II
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    TAPENTADOL HYDROCHLORIDE

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    ALKEM LABORATORIES LT...
    Active
    26519
    Complete
    2013-03-01
    2012-11-08
    2012-10-23
    II
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    TAPENTADOL HYDROCHLORIDE

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    ALKEM LABORATORIES LT...
    Active
    31435
    Complete
    2017-08-18
    2017-03-30
    2017-03-27
    II
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    TOLTERODINE TARTRATE USP

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    ALKEM LABORATORIES LT...
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    30994
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    2017-01-19
    2016-12-08
    2016-09-30
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    TOLVAPTAN

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    ALKEM LABORATORIES LT...
    Active
    32030
    Complete
    2017-11-15
    2017-10-12
    2017-10-06
    II
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    MED-300179/E (INTERMEDIATE)

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    28119
    N/A
    2014-04-16
    II
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