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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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    Granules India Limited
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    India
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    2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500 081 (AP)
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    +91-40-30660000, +91-40-66760000
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    enquiries@pharmacompass.com
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    https://granulesindia.com/
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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
    Active
    34445
    N/A
    2020-01-31
    II
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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
    Complete
    2021-05-27
    2021-04-15
    2021-03-29
    II
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    CETIRIZINE HYDROCHLORIDE, USP

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    GRANULES INDIA LTD
    Active
    30063
    Complete
    2016-03-23
    2015-12-14
    2016-02-01
    II
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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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    COMPRESSO IBU 66S

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    GRANULES INDIA LTD
    Active
    20606
    N/A
    2007-06-12
    II
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    COMPRESSO IBU 85 PAR (IBUPROFEN GRA...

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    GRANULES INDIA LTD
    Active
    35886
    N/A
    2021-05-18
    II
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    COMPRESSO LSP 33.333 % (LOSARTAN PO...

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    GRANULES INDIA LTD
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    36088
    N/A
    2021-07-12
    II
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    COMPRESSO PAP 90 CPC

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    GRANULES INDIA LTD
    Active
    19972
    N/A
    2006-11-16
    II
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    COMPRESSO PAP 90 CPF

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    GRANULES INDIA LTD
    Active
    17722
    N/A
    2004-09-22
    II
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    COMPRESSO PAP 90 CPL

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    GRANULES INDIA LTD
    Active
    18978
    N/A
    2005-11-28
    II
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    COMPRESSO-90-CP(F) (ACETAMINOPHEN G...

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    GRANULES INDIA LTD
    Inactive
    11513
    N/A
    1995-05-11
    II
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    COMPRESSO-90-P (ACETAMINOPHEN GRANU...

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    GRANULES INDIA LTD
    Inactive
    11436
    N/A
    1995-04-05
    II
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    DASATINIB

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    GRANULES INDIA LTD
    Active
    35270
    N/A
    2020-11-23
    II
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    DASATINIB MONOHYDRATE

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    GRANULES INDIA LTD
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    38065
    N/A
    2023-03-31
    II
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    DIMETHYL FUMARATE

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    GRANULES INDIA LTD
    Active
    30938
    Complete
    2016-12-27
    2017-04-12
    2016-09-27
    II
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    ELTROMBOPAG OLAMINE

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    GRANULES INDIA LTD
    Active
    34069
    N/A
    2019-10-02
    II
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    ESOMEPRAZOLE MAGNESIUM DELAYED-RELE...

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    GRANULES INDIA LTD
    Active
    37233
    N/A
    2022-07-01
    II
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    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, ...

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    GRANULES INDIA LTD
    Active
    36556
    Complete
    2023-05-26
    2023-04-18
    2021-12-24
    II
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    FEXOFENADINE HYDROCHLORIDE, USP

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    GRANULES INDIA LTD
    Active
    30604
    Complete
    2016-09-19
    2016-07-12
    2016-08-16
    II
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    FLUCONAZOLE USP

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    GRANULES INDIA LTD
    Inactive
    22710
    N/A
    2009-03-30
    II
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    GABAPENTIN USP

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    GRANULES INDIA LTD
    Inactive
    33536
    N/A
    2019-03-20
    II
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    GUAIFENESIN USP

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    GRANULES INDIA LTD
    Active
    14372
    Complete
    2014-03-19
    2014-03-11
    1999-08-30
    II
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    LAPATINIB DITOSYLATE MONOHYDRATE

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    GRANULES INDIA LTD
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    36602
    N/A
    2022-01-24
    II
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    LEVETIRACETAM USP

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    GRANULES INDIA LTD
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    37775
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    2024-02-12
    2024-01-11
    2022-12-30
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    LEVOCETIRIZINE DIHYDROCHLORIDE USP

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    GRANULES INDIA LTD
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    22898
    Complete
    2022-03-09
    2022-02-08
    2009-05-22
    II
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    LOSARTAN POTASSIUM USP

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    GRANULES INDIA LTD
    Active
    22711
    Complete
    2020-10-09
    2020-09-08
    2009-04-02
    II
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    MELPHALAN HYDROCHLORIDE

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    GRANULES INDIA LTD
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    36096
    N/A
    2021-07-23
    II
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    METFORMIN HYDROCHLORIDE USP

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    GRANULES INDIA LTD
    Active
    16625
    Complete
    2016-07-28
    2016-07-01
    2003-06-06
    II
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    METHOCARBAMOL USP

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    GRANULES INDIA LTD
    Active
    17872
    Complete
    2013-08-28
    2013-08-12
    2004-12-03
    II
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    METOPROLOL SUCCINATE MICROSPHERES 9...

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    GRANULES PHARMACEUTIC...
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    35959
    N/A
    2021-06-13
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    METOPROLOL SUCCINATE USP

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    GRANULES INDIA LTD
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    33544
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    2021-05-27
    2021-04-19
    2019-03-27
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    NAPROXEN SODIUM, USP

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    GRANULES INDIA LTD
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    34691
    N/A
    2020-04-01
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    NILOTINIB HYDROCHLORIDE MONOHYDRATE

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    GRANULES INDIA LTD (U...
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    37531
    N/A
    2022-09-30
    II
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    OLMESARTAN MEDOXOMIL USP

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    GRANULES INDIA LTD
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    36865
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    2022-03-31
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    OMEPRAZOLE MAGNESIUM USP

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    GRANULES INDIA LTD
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    31829
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    2021-11-12
    2021-09-29
    2017-08-31
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    Omeprazole USP

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    2023-08-08
    2023-07-17
    2022-09-29
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    PANTOPRAZOLE SODIUM SESQUIHYDRATE U...

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    25166
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    2011-03-30
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    Pantoprazole Sodium Sesquihydrate, ...

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    2023-04-18
    2022-05-19
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    PAZOPANIB HYDROCHLORIDE

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    PENICILLAMINE, USP

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    2017-11-09
    2017-11-03
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    PIRFENIDONE

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    2018-08-03
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    PRAZOSIN HYDROCHLORIDE USP

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    GRANULES INDIA LTD
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    2020-09-29
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    RIFAXIMIN

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    GRANULES INDIA LTD
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    32351
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    2018-03-30
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    RIFAXIMIN (RSA CODE)

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