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

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    Hikma Pharmaceuticals
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    United Kingdom
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    1 New Burlington Place, Mayfair, London, W1S 2HR
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    +44 (0) 20 7399 2760
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    enquiries@pharmacompass.com
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    https://www.hikma.com/home/
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    https://www.linkedin.com/company/hikma-pharmaceuticals/
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    BETAMETHASONE ACETATE (STERILE) USP

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    HIKMA PHARMACEUTICALS...
    Active
    18126
    N/A
    2005-02-28
    II
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    CEFADROXIL

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    HIKMACHEM BPC
    Inactive
    13220
    N/A
    1998-04-30
    II
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    CORTISONE ACETATE, USP (MICRONIZED)

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    HIKMA PHARMACEUTICALS...
    Inactive
    16659
    N/A
    2003-06-19
    II
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    CYCLOPHOSPHAMIDE LYOPHILIZED FOR IN...

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    BEN VENUE LABORATORIE...
    Inactive
    5541
    N/A
    1984-09-27
    II
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    DASATINIB MONOHYDRATE

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    HIKMA PHARMACEUTICALS...
    Active
    30165
    N/A
    2015-12-29
    II
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    ENALAPRILAT USP

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    HIKMA PHARMACEUTICALS...
    Active
    19809
    N/A
    2006-09-28
    II
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    ERLOTINIB HYDROCHLORIDE

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    HIKMA PHARMACEUTICALS...
    Active
    29437
    N/A
    2015-05-28
    II
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    GLYCOPYRROLATE USP

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    HIKMA PHARMACEUTICALS...
    Active
    18727
    N/A
    2005-08-31
    II
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    GRANISETRON HYDROCHLORIDE USP

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    HIKMA PHARMACEUTICALS
    Active
    25298
    N/A
    2011-09-11
    II
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    HYDROCORTISONE USP

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    HIKMA PHARMACEUTICALS
    Active
    16089
    N/A
    2002-08-06
    II
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    METHOTREXATE SODIUM FOR INJECTION, ...

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    BEN VENUE LABORATORIE...
    Inactive
    6122
    N/A
    1985-12-12
    II
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    METHYLPREDNISOLONE ACETATE USP (STE...

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    HIKMA PHARMACEUTICALS...
    Active
    30789
    N/A
    2016-07-27
    II
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    MILRINONE, USP

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    HIKMA PHARMACEUTICALS...
    Active
    25544
    Complete
    2013-10-04
    2013-07-24
    2011-11-24
    II
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    NICARDIPINE HYDROCHLORIDE

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    HIKMA PHARMACEUTICALS
    Active
    23280
    N/A
    2009-11-16
    II
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    NILOTINIB MONOHYDROCHLORIDE ANHYDRO...

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    HIKMA PHARMACEUTICALS...
    Active
    30164
    N/A
    2015-12-29
    II
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    ONDANSETRON HYDROCHLORIDE, USP

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    HIKMA PHARMACEUTICALS
    Active
    22181
    Complete
    2022-12-21
    2022-12-19
    2008-11-13
    II
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    OXANDROLONE USP

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    HIKMA PHARMACEUTICALS
    Active
    20344
    N/A
    2007-03-06
    II
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    PREDNISONE ANHYDROUS USP

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    HIKMA PHARMACEUTICALS
    Active
    16000
    N/A
    2002-06-10
    II
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    SOLRIAETOL HYDROCHLORIDE

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    HIKMA PHARMACEUTICALS...
    Active
    37548
    Complete
    2023-04-04
    2022-12-19
    2022-12-28
    II
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    SUNITINIB L-MALATE

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    HIKMA PHARMACEUTICALS...
    Active
    31320
    N/A
    2017-02-20
    II
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    UMECLIDINIUM BROMIDE

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    HIKMA PHARMACEUTICALS...
    Active
    35420
    N/A
    2021-04-25
    II
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    ZOLEDRONIC ACID USP

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    HIKMA PHARMACEUTICALS
    Active
    23036
    N/A
    2009-08-09
    II
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    FACILITIES, PERSONNEL AND GENERAL O...

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    AL HIKMA PHARMACEUTIC...
    Inactive
    6917
    N/A
    1987-04-10
    II
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    HIK-078

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    HIKMA PHARMACEUTICALS...
    Active
    33269
    Complete
    2021-09-17
    2021-07-28
    2019-10-31
    II
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    HIK-079

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    HIKMA PHARMACEUTICALS...
    Active
    33746
    Complete
    2021-11-30
    2021-10-04
    2019-04-01
    II
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    MANUFACTURING SITE, FACILITIES, OPE...

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    HIKMACHEM BPC
    Inactive
    10615
    N/A
    1993-12-09
    II
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    PEG-L-ASPARAGINASE

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    BEN VENUE LABORATORIE...
    Inactive
    18604
    N/A
    1989-12-12
    II
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