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

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    INKE S.A

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    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    Key Products KEY PRODUCTS

    • Aclidinium Bromide

    • Arformoterol Tartrate

    • Clevidipine

    • Formoterol Fumarate

    • Glycopyrronium Bromide

    • Glycopyrronium Tosylate

    • Granisetron

    • Granisetron Hydrochloride

    • Indacaterol Acetate

    • Indacaterol Maleate

    • Olodaterol Hydrochloride

    • Revefenacin

    • Salmeterol Xinafoate

    • Tafamidis

    • Tafamidis Meglumine

    • Tiotropium Bromide

    • Umeclidinium Bromide

    • Vilanterol Trifenatate

    SERVICES

    Key Products KEY SERVICES

    • Micronisation Technology

    INSPECTIONS & REGISTRATIONS

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    Inke RM
    Inke S.A
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    Country
    Country
    Spain
    Address
    Address
    Area Industrial Llobregat, Argent,1 08755 Castellbisbal Barcelona
    Telephone
    Telephone
    +34 936828180
    Client Email
    Email
    jsanchez@inke.es
    Client Website
    Website
    https://www.inke.es/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/inke/
    Twitter
    Twitter
    Contact Info
    Others

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    • FDA
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    ACLIDINIUM BROMIDE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    36437
    Complete
    2023-06-14
    2023-04-21
    2023-03-16
    II
    Inke Company Banner

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    APREPITANT

    PDF Supplier PDF
    URL Supplier Web Content
    INKE SA
    Active
    35497
    Complete
    2022-05-31
    2022-05-16
    2022-04-26
    II
    Inke Company Banner

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    • FDA
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    ARFORMOTEROL TARTRATE (FORM A)

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN
    INKE SA
    Active
    36435
    Complete
    2022-07-14
    2022-03-17
    2022-05-16
    II
    Inke Company Banner

    Formulation & Delivery

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    • EDQM
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    ARFORMOTEROL TARTRATE (FORM D)

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN
    INKE SA
    Active
    32990
    Complete
    2019-04-12
    2018-07-17
    2018-07-25
    II
    Inke Company Banner

    Formulation & Delivery

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    • FDA
    • EDQM
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    CLEVIDIPINE BUTYRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU, CN
    INKE SA
    Active
    36436
    Complete
    2022-09-02
    2022-03-17
    2022-06-14
    II
    Inke Company Banner

    Formulation & Delivery

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    FLUCONAZOLE

    PDF Supplier PDF
    URL Supplier Web Content
    NA Not Available For Sales
    INKE SA
    Active
    14714
    N/A
    1999-12-15
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
    • EDQM
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    FORMOTEROL FUMARATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, RU
    INKE SA
    Active
    16628
    Complete
    2017-06-16
    2017-05-10
    2003-06-03
    II
    Inke Company Banner

    Formulation & Delivery

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    Contact Supplier
    • FDA
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    GLYCOPYRROLATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, RU
    INKE SA
    Active
    31836
    Complete
    2018-02-16
    2017-07-06
    2017-07-22
    II
    Inke Company Banner

    Formulation & Delivery

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    Contact Supplier
    • FDA
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    GRANISETRON BASE

    PDF Supplier PDF
    URL Supplier Web Content
    INKE SA
    Active
    21790
    N/A
    2008-06-24
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
    • EDQM
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    GRANISETRON HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    INKE SA
    Active
    17346
    Complete
    2021-12-10
    2021-12-07
    2004-04-05
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
    • EDQM
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    OLANZAPINE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    26694
    Complete
    2014-03-03
    2013-01-23
    2013-01-24
    II
    Inke Company Banner

    Formulation & Delivery

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    • FDA
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    OLODATEROL HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    INKE SA
    Active
    38558
    Complete
    2023-08-23
    2023-07-12
    2023-07-21
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
    • EDQM
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    ONDANSETRON BASE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    16172
    N/A
    2002-09-30
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
    Virtual BoothInke S.A: APIs manufacturing plant.

    ONDANSETRON HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    INKE SA
    Active
    16317
    N/A
    2002-12-13
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
    • EDQM
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    REVEFENACIN TRIHYDRATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    36481
    Complete
    2022-09-01
    2022-03-17
    2022-07-27
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
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    RISPERIDONE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN
    INKE SA
    Active
    15682
    Complete
    2021-06-09
    2021-06-04
    2001-10-23
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
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    RIZATRIPTAN BENZOATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    25623
    N/A
    2011-12-22
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

    envelop Contact Supplier

    Contact Supplier
    • FDA
    • EDQM
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    SALMETEROL XINAFOATE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN
    INKE SA
    Active
    23914
    Complete
    2015-08-12
    2015-05-20
    2010-06-23
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    Contact Supplier
    • FDA
    • EDQM
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    TETRABENAZINE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    37218
    N/A
    2022-06-21
    II
    Inke Company Banner

    Formulation & Delivery

    Attending

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    • FDA
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    TIOTROPIUM BROMIDE MONOHYDRATE (MIC...

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, RU
    INKE SA
    Active
    34410
    Complete
    2021-04-30
    2020-01-13
    2020-03-17
    II
    Inke Company Banner

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    UMECLIDINIUM BROMIDE

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    36482
    Complete
    2023-07-12
    2023-01-09
    2023-06-16
    II
    Inke Company Banner

    Formulation & Delivery

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    • FDA
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    VILANTEROL TRIFENATATE

    PDF Supplier PDF
    URL Supplier Web Content
    INKE SA
    Active
    35498
    Complete
    2023-05-19
    2023-01-09
    2023-03-16
    II
    Inke Company Banner

    Formulation & Delivery

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    • FDA
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    ZOLMITRIPTAN

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF EU
    INKE SA
    Active
    24649
    Complete
    2019-03-06
    2019-02-28
    2011-02-14
    II
    Inke Company Banner

    Formulation & Delivery

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