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

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    Morepen Laboratories
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    Morepen Laboratories Ltd., 2nd Floor, Tower C, DLF Cyber Park, Udyog Vihar, Sector -20, Gurgaon - 122016
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    +91 1244892000
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    APIXABAN

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    35799
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    2021-03-27
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    APIXABAN AMORPHOUS

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    36641
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    2021-12-27
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    APIXABAN FORM H3

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    35900
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    2021-05-03
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    ATORVASTATIN CALCIUM

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    Inactive
    18122
    N/A
    2005-02-23
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    ATORVASTATIN CALCIUM AMORPHOUS, BUL...

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    18402
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    2005-06-06
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    ATORVASTATIN CALCIUM TRIHYDRATE

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    26351
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    2017-05-25
    2017-03-16
    2012-08-23
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    DAPAGLIFLOZIN AMORPHOUS

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    36898
    N/A
    2022-03-14
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    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...

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    34690
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    2020-03-18
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    DESLORATADINE

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    17652
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    2014-01-16
    2014-01-10
    2004-09-07
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    EDOXABAN TOSYLATE

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    36084
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    2021-07-02
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    EMPAGLIFLOZIN

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    33931
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    2019-07-06
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    ERTUGLIFLOZIN L-PYROGLUTAMATE

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    37359
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    2022-07-26
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    FEXOFENADINE HYDROCHLORIDE USP

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    30692
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    2021-02-17
    2020-12-16
    2016-06-27
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    LINAGLIPTIN

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    34162
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    2019-10-04
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    LINAGLIPTIN FORM C

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    36013
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    2021-08-18
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    LORATADINE

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    12650
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    2013-09-28
    2013-09-24
    1997-09-11
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    LORATADINE (PROCESS 2) U.S.P.

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    20669
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    2014-11-13
    2014-11-05
    2007-07-11
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    MONTELUKAST SODIUM

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    24445
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    2014-06-27
    2013-12-30
    2010-12-13
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    OLMESARTAN MEDOXOMIL

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    36555
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    2021-12-02
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    PIOGLITAZONE HYDROCHLORIDE

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    17701
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    2004-09-23
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    RIVAROXABAN

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    36252
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    2021-08-28
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    ROSUVASTATIN CALCIUM

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    33348
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    2018-11-26
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    ROSUVASTATIN CALCIUM PROCESS -2

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    32651
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    2018-03-12
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    SAXAGLIPTIN HYDROCHLORIDE

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    33635
    N/A
    2019-02-27
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    SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE

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    35690
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    2021-02-27
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    SITAGLIPTIN PHOSPHATE ANYDROUS

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    35524
    N/A
    2020-12-31
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    SITAGLIPTIN PHOSPHATE MONOHYDRATE

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    33517
    N/A
    2019-01-17
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    VONOPRAZAN FUMARATE

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    37923
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    2023-01-05
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    VORTIOXETINE HYDROBROMIDE

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    36753
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    2022-01-31
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