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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hikma Pharmaceuticals

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    Hikma Pharmaceuticals
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    Country
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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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    • FDA
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    22181
    Active
    ONDANSETRON HYDROCHLORIDE, USP
    2008-11-13
    CEP/COS

    Caution CEP/COS

    R0-CEP 2017-185 - Rev 00
    Expired
    Ondansetron hydrochloride dihydrate
    2018-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22181
    R0-CEP 2017-185 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Expired
     
    Filing Details
    ONDANSETRON HYDROCHLORIDE, USP
    Ondansetron hydrochloride dihydrate
    Issue/Submission Date
    2008-11-13
    2018-08-17
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    Betamethasone Acetate

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    USDMF

    Found USDMF

    18126
    Active
    BETAMETHASONE ACETATE (STERILE) USP
    2005-02-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18126
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BETAMETHASONE ACETATE (STERILE) USP
    Issue/Submission Date
    2005-02-28
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    Dasatinib

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    USDMF

    Found USDMF

    30165
    Active
    DASATINIB MONOHYDRATE
    2015-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30165
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DASATINIB MONOHYDRATE
    Issue/Submission Date
    2015-12-29
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    Enalaprilat

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    USDMF

    Found USDMF

    19809
    Active
    ENALAPRILAT USP
    2006-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19809
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ENALAPRILAT USP
    Issue/Submission Date
    2006-09-28
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    Erlotinib Hydrochloride

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    USDMF

    Found USDMF

    29437
    Active
    ERLOTINIB HYDROCHLORIDE
    2015-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29437
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ERLOTINIB HYDROCHLORIDE
    Issue/Submission Date
    2015-05-28
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    18727
    Active
    GLYCOPYRROLATE USP
    2005-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18727
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLYCOPYRROLATE USP
    Issue/Submission Date
    2005-08-31
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    25298
    Active
    GRANISETRON HYDROCHLORIDE USP
    2011-09-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25298
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GRANISETRON HYDROCHLORIDE USP
    Issue/Submission Date
    2011-09-11
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    Hydrocortisone

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    USDMF

    Found USDMF

    16089
    Active
    HYDROCORTISONE USP
    2002-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16089
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDROCORTISONE USP
    Issue/Submission Date
    2002-08-06
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    Methylprednisolone Acetate

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    USDMF

    Found USDMF

    30789
    Active
    METHYLPREDNISOLONE ACETATE USP (STE...
    2016-07-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30789
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METHYLPREDNISOLONE ACETATE USP (STE...
    Issue/Submission Date
    2016-07-27
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    Milrinone

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    USDMF

    Found USDMF

    25544
    Active
    MILRINONE, USP
    2011-11-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25544
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MILRINONE, USP
    Issue/Submission Date
    2011-11-24
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    Nicardipine Hydrochloride

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    USDMF

    Found USDMF

    23280
    Active
    NICARDIPINE HYDROCHLORIDE
    2009-11-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23280
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NICARDIPINE HYDROCHLORIDE
    Issue/Submission Date
    2009-11-16
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    Nilotinib

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    USDMF

    Found USDMF

    30164
    Active
    NILOTINIB MONOHYDROCHLORIDE ANHYDRO...
    2015-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30164
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NILOTINIB MONOHYDROCHLORIDE ANHYDRO...
    Issue/Submission Date
    2015-12-29
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    Oxandrolone

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    USDMF

    Found USDMF

    20344
    Active
    OXANDROLONE USP
    2007-03-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20344
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OXANDROLONE USP
    Issue/Submission Date
    2007-03-06
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    Prednisone

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    USDMF

    Found USDMF

    16000
    Active
    PREDNISONE ANHYDROUS USP
    2002-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16000
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PREDNISONE ANHYDROUS USP
    Issue/Submission Date
    2002-06-10
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    Solriamfetol Hydrochloride

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    USDMF

    Found USDMF

    37548
    Active
    SOLRIAETOL HYDROCHLORIDE
    2022-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37548
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SOLRIAETOL HYDROCHLORIDE
    Issue/Submission Date
    2022-12-28
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    Sunitinib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31320
    Active
    SUNITINIB L-MALATE
    2017-02-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31320
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SUNITINIB L-MALATE
    Issue/Submission Date
    2017-02-20
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    Umeclidinium Bromide

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    USDMF

    Found USDMF

    35420
    Active
    UMECLIDINIUM BROMIDE
    2021-04-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35420
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    UMECLIDINIUM BROMIDE
    Issue/Submission Date
    2021-04-25
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    Zoledronic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23036
    Active
    ZOLEDRONIC ACID USP
    2009-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23036
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZOLEDRONIC ACID USP
    Issue/Submission Date
    2009-08-09
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    HIK-078

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    USDMF

    Found USDMF

    33269
    Active
    HIK-078
    2019-10-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33269
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HIK-078
    Issue/Submission Date
    2019-10-31
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    HIK-079

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    USDMF

    Found USDMF

    33746
    Active
    HIK-079
    2019-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33746
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HIK-079
    Issue/Submission Date
    2019-04-01
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    • FDA
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    Cefadroxil

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    USDMF

    Caution USDMF

    13220
    Inactive
    CEFADROXIL
    1998-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13220
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CEFADROXIL
    Issue/Submission Date
    1998-04-30
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    Cortisone

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16659
    Inactive
    CORTISONE ACETATE, USP (MICRONIZED)
    2003-06-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16659
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CORTISONE ACETATE, USP (MICRONIZED)
    Issue/Submission Date
    2003-06-19
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    Cyclophosphamide

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    USDMF

    Caution USDMF

    5541
    Inactive
    CYCLOPHOSPHAMIDE LYOPHILIZED FOR IN...
    1984-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5541
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CYCLOPHOSPHAMIDE LYOPHILIZED FOR IN...
    Issue/Submission Date
    1984-09-27
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    Methotrexate

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    6122
    Inactive
    METHOTREXATE SODIUM FOR INJECTION, ...
    1985-12-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6122
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    METHOTREXATE SODIUM FOR INJECTION, ...
    Issue/Submission Date
    1985-12-12
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    FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES ...

    PDF Supplier PDF
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    See all info for this product

    See Less

    USDMF

    Caution USDMF

    6917
    Inactive
    FACILITIES, PERSONNEL AND GENERAL O...
    1987-04-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6917
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITIES, PERSONNEL AND GENERAL O...
    Issue/Submission Date
    1987-04-10
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    MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AN...

    PDF Supplier PDF
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    See Less

    USDMF

    Caution USDMF

    10615
    Inactive
    MANUFACTURING SITE, FACILITIES, OPE...
    1993-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10615
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, OPE...
    Issue/Submission Date
    1993-12-09
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    PEG-L-ASPARAGINASE

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    USDMF

    Caution USDMF

    18604
    Inactive
    PEG-L-ASPARAGINASE
    1989-12-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18604
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PEG-L-ASPARAGINASE
    Issue/Submission Date
    1989-12-12
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    Benztropine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Fluticasone Propionate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    Ibrutinib

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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