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

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    01 ACETAMINOPHEN (1)

    02 ACETAMINOPHEN USP (1)

    03 ATAZANAVIR SULFATE (1)

    04 BORTEZOMIB (1)

    05 BROMPHENIRAMINE MALEATE USP (1)

    06 BUPROPION HYDROCHLORIDE USP (1)

    07 CETIRIZINE HYDROCHLORIDE, USP (1)

    08 COMPRESSO 95P (1)

    09 COMPRESSO GGF 95 SA (GUAIFENESIN GRANULES 95%) (1)

    10 COMPRESSO GGF 95P (1)

    11 COMPRESSO GGF95 (1)

    12 COMPRESSO IBU 66S (1)

    13 COMPRESSO IBU 85 PAR (IBUPROFEN GRANULES DC 85 %) (1)

    14 COMPRESSO LSP 33.333 % (LOSARTAN POTASSIUM DIRECTLY COMPRESSIBLE GRANULES) (1)

    15 COMPRESSO PAP 90 CPC (1)

    16 COMPRESSO PAP 90 CPF (1)

    17 COMPRESSO PAP 90 CPL (1)

    18 COMPRESSO PAP 90CPC (1)

    19 COMPRESSO PAP 90CPF (1)

    20 COMPRESSO-90-CP(F) (ACETAMINOPHEN GRANULES 90%) (1)

    21 COMPRESSO-90-P (ACETAMINOPHEN GRANULES 90%) (1)

    22 Chlorpheniramine Maleate USP (1)

    23 DASATINIB (1)

    24 DASATINIB MONOHYDRATE (1)

    25 DIMETHYL FUMARATE (1)

    26 ELTROMBOPAG OLAMINE (1)

    27 ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE PELLETS (25.82% W/W) (1)

    28 ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, USP (1)

    29 FEXOFENADINE HYDROCHLORIDE, USP (1)

    30 FLUCONAZOLE USP (1)

    31 GABAPENTIN USP (1)

    32 GUAIFENESIN USP (1)

    33 LAPATINIB DITOSYLATE MONOHYDRATE (1)

    34 LEVETIRACETAM USP (1)

    35 LEVOCETIRIZINE DIHYDROCHLORIDE USP (1)

    36 LOSARTAN POTASSIUM USP (1)

    37 MELPHALAN HYDROCHLORIDE (1)

    38 METFORMIN HYDROCHLORIDE USP (1)

    39 METHOCARBAMOL USP (1)

    40 METOPROLOL SUCCINATE MICROSPHERES 90% W/W (1)

    41 METOPROLOL SUCCINATE USP (1)

    42 NAPROXEN SODIUM, USP (1)

    43 NILOTINIB HYDROCHLORIDE MONOHYDRATE (1)

    44 OLMESARTAN MEDOXOMIL USP (1)

    45 OMEPRAZOLE MAGNESIUM USP (1)

    46 Omeprazole USP (1)

    47 PANTOPRAZOLE SODIUM SESQUIHYDRATE USP (1)

    48 PAZOPANIB HYDROCHLORIDE (1)

    49 PENICILLAMINE, USP (1)

    50 PIRFENIDONE (1)

    51 PRAZOSIN HYDROCHLORIDE USP (1)

    52 Pantoprazole Sodium Sesquihydrate, USP (1)

    53 RIFAXIMIN (1)

    54 RIFAXIMIN (RSA CODE) (1)

    55 SORAFENIB TOSYLATE USP (1)

    56 TRAZODONE HYDROCHLORIDE USP (1)

    57 VIGABATRIN, USP (1)

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    01 GRANULES INDIA LTD (55)

    02 GRANULES INDIA LTD (UNIT-V) (1)

    03 GRANULES PHARMACEUTICALS INC (1)

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    01 India (57)

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    01 Active (43)

    02 Inactive (14)

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    01 Complete (20)

    02 Blank (37)

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    ACETAMINOPHEN

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    GRANULES INDIA LTD
    Inactive
    17721
    N/A
    2004-09-22
    II
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    ACETAMINOPHEN USP

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    GRANULES INDIA LTD
    Active
    19804
    Complete
    2013-06-08
    2012-11-29
    2006-09-28
    II
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    ATAZANAVIR SULFATE

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    GRANULES INDIA LTD
    Active
    32259
    N/A
    2017-12-27
    II
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    BORTEZOMIB

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    GRANULES INDIA LTD
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    34445
    N/A
    2020-01-31
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    BROMPHENIRAMINE MALEATE USP

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    GRANULES INDIA LTD
    Inactive
    20604
    N/A
    2007-06-12
    II
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    BUPROPION HYDROCHLORIDE USP

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    GRANULES INDIA LTD
    Active
    35694
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    2021-05-27
    2021-04-15
    2021-03-29
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    CETIRIZINE HYDROCHLORIDE, USP

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    GRANULES INDIA LTD
    Active
    30063
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    2016-03-23
    2015-12-14
    2016-02-01
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    Chlorpheniramine Maleate USP

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    GRANULES INDIA LTD
    Inactive
    21003
    N/A
    2007-10-31
    II
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    COMPRESSO 95P

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    GRANULES INDIA LTD
    Active
    17723
    N/A
    2004-09-22
    II
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    COMPRESSO GGF 95 SA (GUAIFENESIN GR...

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    GRANULES INDIA LTD
    Active
    20998
    N/A
    2007-10-31
    II
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