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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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    01 ACLIDINIUM BROMIDE (1)

    02 APREPITANT (1)

    03 ARFORMOTEROL TARTRATE (FORM A) (1)

    04 ARFORMOTEROL TARTRATE (FORM D) (1)

    05 CLEVIDIPINE BUTYRATE (1)

    06 FLUCONAZOLE (1)

    07 FORMOTEROL FUMARATE (1)

    08 GLYCOPYRROLATE (1)

    09 GRANISETRON BASE (1)

    10 GRANISETRON HYDROCHLORIDE (1)

    11 OLANZAPINE (1)

    12 OLODATEROL HYDROCHLORIDE (1)

    13 ONDANSETRON BASE (1)

    14 ONDANSETRON HYDROCHLORIDE (1)

    15 REVEFENACIN TRIHYDRATE (1)

    16 RISPERIDONE (1)

    17 RIZATRIPTAN BENZOATE (1)

    18 SALMETEROL XINAFOATE (1)

    19 TETRABENAZINE (1)

    20 TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED) (1)

    21 UMECLIDINIUM BROMIDE (1)

    22 VILANTEROL TRIFENATATE (1)

    23 ZOLMITRIPTAN (1)

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    ACLIDINIUM BROMIDE

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    INKE SA
    Active
    36437
    Complete
    2023-06-14
    2023-04-21
    2023-03-16
    II
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    APREPITANT

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    INKE SA
    Active
    35497
    Complete
    2022-05-31
    2022-05-16
    2022-04-26
    II
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    ARFORMOTEROL TARTRATE (FORM A)

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    Other DMF CN
    INKE SA
    Active
    36435
    Complete
    2022-07-14
    2022-03-17
    2022-05-16
    II
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    ARFORMOTEROL TARTRATE (FORM D)

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    INKE SA
    Active
    32990
    Complete
    2019-04-12
    2018-07-17
    2018-07-25
    II
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    CLEVIDIPINE BUTYRATE

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    Other DMF EU, CN
    INKE SA
    Active
    36436
    Complete
    2022-09-02
    2022-03-17
    2022-06-14
    II
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    FLUCONAZOLE

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    NA Not Available For Sales
    INKE SA
    Active
    14714
    N/A
    1999-12-15
    II
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    FORMOTEROL FUMARATE

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    Other DMF CN, RU
    INKE SA
    Active
    16628
    Complete
    2017-06-16
    2017-05-10
    2003-06-03
    II
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    GLYCOPYRROLATE

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    Other DMF CN, RU
    INKE SA
    Active
    31836
    Complete
    2018-02-16
    2017-07-06
    2017-07-22
    II
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    GRANISETRON BASE

    PDF Supplier PDF
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    INKE SA
    Active
    21790
    N/A
    2008-06-24
    II
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    GRANISETRON HYDROCHLORIDE

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