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

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    01 ALFUZOSIN HYDROCHLORIDE USP (1)

    02 ALLOPURINOL USP (1)

    03 AMIODARONE HYDROCHLORIDE USP (1)

    04 AMLODIPINE BESILATE USP (1)

    05 APIXABAN (1)

    06 APREMILAST (1)

    07 ARIPIPRAZOLE USP (1)

    08 ATOMOXETINE HYDROCHLORIDE USP (1)

    09 BACLOFEN USP (1)

    10 BENDROFLUMETHIAZIDE USP (1)

    11 BISOPROLOL FUMARATE USP (1)

    12 BREXPIPRAZOLE (1)

    13 BRIMONIDINE TARTRATE (1)

    14 BUPRENORPHINE HYDROCHLORIDE (1)

    15 BUPRENORPHINE HYDROCHLORIDE USP (1)

    16 BUSPIRONE HYDROCHLORIDE USP (1)

    17 CELECOXIB USP (1)

    18 CETIRIZINE HYDROCHLORIDE USP (1)

    19 CHLORTHALIDONE USP (1)

    20 CINACALCET HYDROCHLORIDE (1)

    21 CLOMIPHENE CITRATE (1)

    22 CLONIDINE HYDROCHLORIDE (1)

    23 CLONIDINE HYDROCHLORIDE USP (1)

    24 CYCLOBENZAPRINE HYDROCHLORIDE USP (1)

    25 DIMETHYL FUMARATE (1)

    26 DIPHENHYDRAMINE HYDROCHLORIDE (2)

    27 DONEPEZIL HYDROCHLORIDE MONOHYDRATE USP (1)

    28 DOXAZOSIN MESYLATE USP (1)

    29 EPROSARTAN MESYLATE (1)

    30 FENOFIBRATE USP (1)

    31 GLIPIZIDE USP (1)

    32 GUANFACINE HYDROCHLORIDE USP (1)

    33 HYDRALAZINE HYDROCHLORIDE USP (1)

    34 HYDROCHLOROTHIAZIDE B.P. (1)

    35 HYDROCHLOROTHIAZIDE USP (1)

    36 HYDROCHLOROTHIAZIDE USP - PROCESS #2 (1)

    37 IRBESARTAN USP (1)

    38 LABETALOL HYDROCHLORIDE USP (1)

    39 LACIDIPINE BP (1)

    40 LACOSAMIDE (1)

    41 LAMOTRIGINE USP API (1)

    42 LEFLUNOMIDE (1)

    43 LOSARTAN POTASSIUM USP (1)

    44 LURASIDONE HYDROCHLORIDE (1)

    45 MECLIZINE HCL USP (1)

    46 MELOXICAM USP (1)

    47 MEMANTINE HYDROCHLORIDE USP (1)

    48 METOPROLOL SUCCINATE USP (1)

    49 METRONIDAZOLE BENZOATE (1)

    50 METRONIDAZOLE USP (2)

    51 MILNACIPRAN HYDROCHLORIDE (1)

    52 MIRABEGRON (1)

    53 MONTELUKAST SODIUM USP (1)

    54 NATEGLINIDE (1)

    55 NATEGLINIDE (FORM-H) USP (1)

    56 NIFEDIPINE USP (1)

    57 OLMESARTAN MEDOXOMIL USP (1)

    58 PALIPERIDONE (1)

    59 PHENYLEPHRINE HYDROCHLORIDE USP (1)

    60 PHENYTOIN SODIUM USP (1)

    61 PIROXICAM USP (1)

    62 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE USP (1)

    63 PRASUGREL HYDROCHLORIDE USP (1)

    64 PYRIDOSTIGMINE BROMIDE (1)

    65 QUETIAPINE FUMARATE (QPT PROCESS) (1)

    66 QUETIAPINE FUMARATE USP (1)

    67 RANOLAZINE (1)

    68 RIVAROXABAN (1)

    69 RIZATRIPTAN BENZOATE USP (1)

    70 SACUBITRIL (1)

    71 SOLIFENACIN SUCCINATE (1)

    72 SOLRIAETOL HYDROCHLORIDE (1)

    73 SUCRALFATE (1)

    74 TADALAFIL USP (1)

    75 TAMSULOSIN HYDROCHLORIDE USP (1)

    76 TELMISARTAN USP (1)

    77 TERIFLUNOMIDE (1)

    78 THIACETAZONE (1)

    79 TIAGABINE HYDROCHLORIDE USP (1)

    80 TICAGRELOR (1)

    81 TIZANIDINE HCL USP (1)

    82 TOFACITINIB CITRATE (1)

    83 TOLTERODINE TARTRATE USP (1)

    84 TOPIRAMATE USP (1)

    85 TRAMADOL HYDROCHLORIDE USP (1)

    86 VORTIOXETINE HYDROBROMIDE (1)

    87 WARFARIN SODIUM USP (1)

    88 ZOLMITRIPTAN USP (1)

    89 ZOLPIDEM TARTRATE USP (1)

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    01 UNICHEM LABORATORIES LTD (91)

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    01 India (91)

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    01 Active (76)

    02 Inactive (15)

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    01 Complete (50)

    02 Blank (41)

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    ALFUZOSIN HYDROCHLORIDE USP

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    UNICHEM LABORATORIES ...
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    2009-03-30
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    ALLOPURINOL USP

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    AMIODARONE HYDROCHLORIDE USP

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    AMLODIPINE BESILATE USP

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    2013-09-14
    2013-09-06
    2003-04-01
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    APIXABAN

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    2016-11-17
    2016-09-15
    2016-09-16
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    APREMILAST

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    2018-02-28
    2017-12-22
    2017-12-22
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    ARIPIPRAZOLE USP

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    2010-09-02
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    ATOMOXETINE HYDROCHLORIDE USP

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    2019-02-15
    2018-11-29
    2018-09-28
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    BACLOFEN USP

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    UNICHEM LABORATORIES ...
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    2018-03-22
    2018-01-12
    2018-03-07
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    BENDROFLUMETHIAZIDE USP

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    2002-02-04
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