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

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    01 ALMOTRIPTAN MALATE (1)

    02 APIXABAN (1)

    03 ARIPIPRAZOLE (1)

    04 ARIPIPRAZOLE USP (1)

    05 EFAVIRENZ USP (1)

    06 ELETRIPTAN HYDROBROMIDE MONOHYDRATE (1)

    07 FAMOTIDINE USP (1)

    08 HYDROXYCHLOROQUINE SULFATE USP (1)

    09 IBUPROFEN USP (1)

    10 IMIDAPRIL HYDROCHLORIDE (1)

    11 ITRACONAZOLE USP (1)

    12 LAMIVUDINE USP (1)

    13 LAMOTRIGINE USP (1)

    14 LANSOPRAZOLE USP (1)

    15 LEVETIRACETAM USP (1)

    16 MOLNUPIRAVIR (1)

    17 NICOTINE POLACRILEX USP (1)

    18 ONDANSETRON HYDROCHLORIDE USP (1)

    19 PANTOPRAZOLE SODIUM SESQUIHYDRATE (1)

    20 PANTOPRAZOLE SODIUM USP (1)

    21 PENCICLOVIR (1)

    22 PIRFENIDONE (1)

    23 RAMIPRIL (1)

    24 RANITIDINE HYDROCHLORIDE (1)

    25 RANITIDINE HYDROCHLORIDE USP (1)

    26 RANITIDINE HYDROCHLORIDE USP (PROCESS -2) (1)

    27 RANITIDINE HYDROCHLORIDE USP (UNIT-VII) (1)

    28 RIVAROXABAN (1)

    29 RIZATRIPTAN BENZOATE (1)

    30 ROSIGLITAZONE MALEATE (1)

    31 ROSIGLITAZONE MALEATE USP (1)

    32 SILDENAFIL CITRATE (UNIT-II) (1)

    33 SOLIFENACIN SUCCINATE (1)

    34 SUMATRIPTAN SUCCINATE (1)

    35 SUMATRIPTAN SUCCINATE (ALTERNATIVE SYNTHESIS) (1)

    36 SUMATRIPTAN USP (1)

    37 SUMATRIPTAN USP (ALTERNATIVE SYNTHESIS) (1)

    38 Sildenafil Citrate (1)

    39 TADALAFIL (1)

    40 VARDENAFIL HYDROCHLORIDE TRIHYDRATE USP (1)

    41 ZOLMITRIPTAN (1)

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    01 SMS PHARMACEUTICALS LTD (41)

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    01 India (41)

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    01 Active (29)

    02 Inactive (12)

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    01 Complete (19)

    02 Blank (22)

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    ALMOTRIPTAN MALATE

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    SMS PHARMACEUTICALS L...
    Active
    18962
    Complete
    2013-01-31
    2013-01-08
    2005-11-18
    II
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    APIXABAN

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    SMS PHARMACEUTICALS L...
    Active
    33520
    N/A
    2019-01-31
    II
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    ARIPIPRAZOLE

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    SMS PHARMACEUTICALS L...
    Inactive
    22339
    N/A
    2008-12-23
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    ARIPIPRAZOLE USP

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    SMS PHARMACEUTICALS L...
    Active
    29991
    Complete
    2021-02-18
    2021-02-08
    2015-11-04
    II
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    EFAVIRENZ USP

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    SMS PHARMACEUTICALS L...
    Active
    34356
    N/A
    2021-03-17
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    ELETRIPTAN HYDROBROMIDE MONOHYDRATE

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    SMS PHARMACEUTICALS L...
    Active
    24905
    Complete
    2014-03-04
    2013-09-25
    2011-05-02
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    FAMOTIDINE USP

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    SMS PHARMACEUTICALS L...
    Active
    21442
    Complete
    2014-01-14
    2013-08-30
    2008-03-20
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    HYDROXYCHLOROQUINE SULFATE USP

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    SMS PHARMACEUTICALS L...
    Active
    37131
    Complete
    2022-06-28
    2022-06-13
    2022-05-19
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    IBUPROFEN USP

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    SMS PHARMACEUTICALS L...
    Active
    35215
    Complete
    2020-11-12
    2020-09-22
    2020-09-30
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    IMIDAPRIL HYDROCHLORIDE

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    SMS PHARMACEUTICALS L...
    Active
    22705
    N/A
    2009-04-07
    II
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