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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Urquima S.A. Grupo Uriach

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    URQUIMA S.A. GRUPO URIACH

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    Urquima S.A. Grupo Uriach
    Spain_new Flag
    Country
    Country
    Spain
    Address
    Address
    Polígono Industrial Riera de Caldes, Avinguda Camí Reial, 51-57, 08184 Palau-solità i Plegamans, Barcelona
    Telephone
    Telephone
    34 938 649 692
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.uriach.com/en/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/grupo-uriach
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    Twitter
    https://twitter.com/Uriach

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    • FDA
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    Rupatadine Fumarate

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    USDMF

    Found USDMF

    36047
    Active
    RUPATADINE FUMARATE
    2021-08-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-202 - Rev 00
    Valid
    Rupatadine fumarate
    2023-08-09
    Japanese DMF

    Found JDMF

    228MF10183
    Rupatajinfumaru salt at Poli(´)gon...
    2016-09-09
    Written Confirmation

    Close WC

    Application Number
    36047
    R1-CEP 2017-202 - Rev 00
    228MF10183
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    RUPATADINE FUMARATE
    Rupatadine fumarate
    Rupatajinfumaru salt at Poli(´)gon...
    Issue/Submission Date
    2021-08-09
    2023-08-09
    2016-09-09
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    Ropinirole Hydrochloride

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    USDMF

    Caution USDMF

    17880
    Inactive
    ROPINIROLE HYDROCHLORIDE
    2004-12-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-117 - Rev 00
    Valid
    Ropinirole hydrochloride
    2022-06-10
    Japanese DMF

    Found JDMF

    227MF10077
    Ropinirole hydrochloride at Poli(')...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    17880
    R1-CEP 2016-117 - Rev 00
    227MF10077
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ROPINIROLE HYDROCHLORIDE
    Ropinirole hydrochloride
    Ropinirole hydrochloride at Poli(')...
    Issue/Submission Date
    2004-12-08
    2022-06-10
    2015-03-12
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    Azelastine Hydrochloride

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    USDMF

    Found USDMF

    20314
    Active
    AZELASTINE HCL
    2007-02-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-097 - Rev 02
    Valid
    Azelastine hydrochloride
    2021-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20314
    R1-CEP 2007-097 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AZELASTINE HCL
    Azelastine hydrochloride
    Issue/Submission Date
    2007-02-12
    2021-06-16
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    Glipizide

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    USDMF

    Found USDMF

    10046
    Active
    GLIPIZIDE
    1993-01-19
    CEP/COS

    Found CEP/COS

    R1-CEP 1997-114 - Rev 04
    Valid
    Glipizide, Regular - Micronised
    2011-07-08
    Japanese DMF

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    Written Confirmation

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    Application Number
    10046
    R1-CEP 1997-114 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GLIPIZIDE
    Glipizide, Regular - Micronised
    Issue/Submission Date
    1993-01-19
    2011-07-08
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    Flutrimazole

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    USDMF

    Caution USDMF

    12806
    Inactive
    FLUTRIMAZOLE
    1997-12-24
    CEP/COS

    Found CEP/COS

    CEP 1999-108 - Rev 04
    Valid
    Flutrimazole
    2023-11-20
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    12806
    CEP 1999-108 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUTRIMAZOLE
    Flutrimazole
    Issue/Submission Date
    1997-12-24
    2023-11-20
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    Glimepiride

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    USDMF

    Caution USDMF

    18396
    Inactive
    GLIMEPIRIDE, MICRONISED
    2005-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-017 - Rev 03
    Valid
    Glimepiride
    2022-06-10
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    18396
    R1-CEP 2007-017 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GLIMEPIRIDE, MICRONISED
    Glimepiride
    Issue/Submission Date
    2005-06-03
    2022-06-10
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    Carvedilol

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    USDMF

    Caution USDMF

    18158
    Inactive
    CARVEDILOL, MICRONIZED
    2005-03-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2003-248 - Rev 00
    Withdrawn by Holder
    Carvedilol
    2010-04-21
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    18158
    R1-CEP 2003-248 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CARVEDILOL, MICRONIZED
    Carvedilol
    Issue/Submission Date
    2005-03-11
    2010-04-21
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    Ivabradine Hydrochloride

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    USDMF

    Found USDMF

    33213
    Active
    IVABRADINE HYDROCHLORIDE (FORM IV)
    2018-10-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    33213
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IVABRADINE HYDROCHLORIDE (FORM IV)
    Issue/Submission Date
    2018-10-15
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    Olopatadine Hydrochloride

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    USDMF

    Found USDMF

    19417
    Active
    OLOPATADINE HYDROCHLORIDE
    2006-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    19417
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OLOPATADINE HYDROCHLORIDE
    Issue/Submission Date
    2006-05-09
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    Triflusal

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2000-032 - Rev 04
    Valid
    Triflusal
    2019-08-14
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2000-032 - Rev 04
    Status
    Valid
     
    Filing Details
    Triflusal
    Issue/Submission Date
    2019-08-14
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    • FDA
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    Albaconazole

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    USDMF

    Caution USDMF

    28242
    Inactive
    ALBACONAZOLE
    2014-05-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    28242
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ALBACONAZOLE
    Issue/Submission Date
    2014-05-14
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    Oleic Acid Chloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2000-368 - Rev 00
    Withdrawn by Holder
    Oleic Acid, Uniqema Bromborough (UK...
    2006-07-10
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2000-368 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Oleic Acid, Uniqema Bromborough (UK...
    Issue/Submission Date
    2006-07-10
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    Sodium Butyrate

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2001-100 - Rev 01
    Expired
    Fatty acid sodium soap base, Prisav...
    2005-03-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2001-100 - Rev 01
    Status
    Expired
     
    Filing Details
    Fatty acid sodium soap base, Prisav...
    Issue/Submission Date
    2005-03-22
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    • FDA
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    FACILITIES AND OPERATING PROCEDURES IN BARCELONA, SPAIN...

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    USDMF

    Caution USDMF

    9954
    Inactive
    FACILITIES AND OPERATING PROCEDURES...
    1992-11-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9954
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FACILITIES AND OPERATING PROCEDURES...
    Issue/Submission Date
    1992-11-09
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