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

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    Lee Pharma
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    SY. No. : 257 & 258/1, Door No : 11-6/56-C, Opp : IDPL Factory, Moosapet, Balanagar ( Post ), Hyderabad – 500 037,
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    APIXABAN

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    LEE PHARMA LTD
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    2022-12-12
    2022-11-23
    2022-08-25
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    BEMPEDOIC ACID

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    36010
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    2021-06-28
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    BILASTINE

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    36288
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    2021-09-16
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    BRIVARACETAM

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    LEE PHARMA LTD
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    39008
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    2023-10-09
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    CARIPRAZINE HYDROCHLORIDE

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    LEE PHARMA LIMITED
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    38749
    N/A
    2023-09-14
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    DABIGATRAN ETEXILATE MESYLATE

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    LEE PHARMA LTD
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    36181
    N/A
    2021-11-17
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    DAPAGLIFLOZIN

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    36994
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    2024-04-01
    2024-02-14
    2023-06-12
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    Dapagliflozin Propanediol Monohydra...

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    35792
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    2021-07-22
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    DEXLANSOPRAZOLE SESQUIHYDRATE

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    38183
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    2023-04-03
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    EMPAGLIFLOZIN

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    2024-02-27
    2024-01-13
    2022-08-16
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    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...

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    2022-11-01
    2022-09-19
    2020-02-18
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    LANSOPRAZOLE USP

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    2014-04-25
    2013-01-07
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    LINAGLIPTIN

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    36923
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    2023-09-02
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    LINEZOLID USP

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    37732
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    2022-12-05
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    LURASIDONE HYDROCHLORIDE

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    36492
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    2021-12-10
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    MIROGABALIN BESYLATE

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    38908
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    2023-09-20
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    OMEPRAZOLE

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    37921
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    2023-05-25
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    RALTEGRAVIR INTERMEDIATE "BENZYL (2...

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    38431
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    2023-05-25
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    RELUGOLIX

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    37365
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    2022-09-06
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    RIVAROXABAN

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    2022-06-03
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    ROSUVASTATIN CALCIUM USP

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    2020-09-23
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    SERTRALINE HYDROCHLORIDE FORM-II

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    37733
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    2023-04-06
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    SITAGLIPTIN PHOSPHATE USP

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    2020-11-18
    2020-09-29
    2020-09-30
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    SITAGLIPTIN PHOSPHATE USP (ROUTE-1)

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    37299
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    2022-07-19
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    TEGOPRAZAN

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    39156
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    2023-11-18
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    TOFACITINIB CITRATE

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    37496
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    2022-11-04
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    UPADACITINIB

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    39581
    N/A
    2024-03-12
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    VARENICLINE BASE (INTERMEDIATE OF V...

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    31576
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    2017-03-30
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    VARENICLINE TARTRATE

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    2019-11-12
    2019-07-24
    2018-11-29
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    VILDAGLIPTIN

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    37495
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    2022-10-03
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    VILOXAZINE HYDROCHLORIDE

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    39582
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    2024-03-12
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    VONOPRAZAN FUMARATE

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    2023-09-02
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    ELETROMBOPAG OLAMINE

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    2024-03-02
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    OLANZAPINE (FORM-I)

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    39150
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    2023-12-05
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    TEGOPRAZAN CRYSTALLINE

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    39217
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    2023-11-29
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