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

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    01 AMLODIPINE BENZOATE (1)

    02 AMLODIPINE BESYLATE USP (1)

    03 APREMILAST (1)

    04 ARIPIPRAZOLE USP (1)

    05 AZILSARTAN KAMEDOXOMIL (1)

    06 BEMPEDOIC ACID (1)

    07 Bis-Boc-Lisdexaetamine (1)

    08 CANAGLIFLOZIN (1)

    09 CANNABIDIOL (1)

    10 DALFAMPRIDINE USP (1)

    11 DEXMETHYLPHENIDATE HYDROCHLORIDE (1)

    12 DIMETHYL FUMARATE (1)

    13 DRONEDARONE HYDROCHLORIDE (1)

    14 DULOXETINE HYDROCHLORIDE (1)

    15 ELUXADOLINE (1)

    16 ESKETAMINE HYDROCHLORIDE (1)

    17 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (1)

    18 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP (1)

    19 LAMOTRIGINE (1)

    20 LANSOPRAZOLE USP (1)

    21 LANTHANUM CARBONATE OCTAHYDRATE (1)

    22 LISDEXAETAMINE DIMESYLATE (1)

    23 MED-300179/E (INTERMEDIATE) (1)

    24 MESALAMINE USP (1)

    25 METHYLPHENIDATE HYDROCHLORIDE USP (1)

    26 N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERIDINAMINE (1)

    27 OLANZAPINE USP (1)

    28 RABEPRAZOLE SODIUM USP (1)

    29 RASAGILINE MESYLATE (1)

    30 RILUZOLE USP (1)

    31 RITALINIC ACID (1)

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    34 Solriaetol Hydrochloride (1)

    35 TAPENTADOL HYDROCHLORIDE (2)

    36 TOLTERODINE TARTRATE USP (1)

    37 TOLVAPTAN (1)

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    AMLODIPINE BENZOATE

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

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    ALKEM LABORATORIES LT...
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    29703
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    2016-03-03
    2015-10-06
    2015-09-28
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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
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    ARIPIPRAZOLE USP

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

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    ALKEM LABORATORIES LT...
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    2023-09-12
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    BEMPEDOIC ACID

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    2023-11-01
    2023-09-22
    2023-08-31
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    Bis-Boc-Lisdexaetamine

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    2021-10-25
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    CANAGLIFLOZIN

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

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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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    2014-01-24
    2013-11-19
    2013-11-01
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