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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Inke S.a

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    01 Aclidinium Bromide (1)

    02 Aprepitant (1)

    03 Arformoterol Tartrate (2)

    04 Asenapine Maleate (1)

    05 Benserazide Hydrochloride (1)

    06 Carvedilol (1)

    07 Clevidipine (1)

    08 Eletriptan Hydrobromide (2)

    09 Enalapril Maleate (1)

    10 Fluconazole (1)

    11 Formoterol Fumarate (1)

    12 Glycopyrronium Bromide (1)

    13 Glycopyrronium Tosylate (1)

    14 Granisetron (1)

    15 Granisetron Hydrochloride (1)

    16 Imidapril Hydrochloride (1)

    17 Indacaterol Acetate (1)

    18 Indacaterol Maleate (1)

    19 Lasmiditan (1)

    20 Loratadine (1)

    21 Mavacamten (1)

    22 Montelukast Sodium (2)

    23 Nitrendipine (1)

    24 Olanzapine (1)

    25 Olodaterol Hydrochloride (1)

    26 Ondansetron (1)

    27 Ondansetron Hydrochloride (1)

    28 Otilonium Bromide (1)

    29 Prasugrel (1)

    30 Prasugrel Hydrochloride (1)

    31 Quetiapine Hemifumarate (1)

    32 Revefenacin (1)

    33 Risperidone (1)

    34 Rivaroxaban (1)

    35 Rizatriptan Benzoate (1)

    36 Salmeterol Xinafoate (1)

    37 Solriamfetol Hydrochloride (1)

    38 Tafamidis (1)

    39 Tafamidis Meglumine (1)

    40 Telmisartan (1)

    41 Tetrabenazine (1)

    42 Tiotropium Bromide (1)

    43 Umeclidinium Bromide (1)

    44 Vilanterol Trifenatate (1)

    45 Zolmitriptan (1)

    filter

    01 Active (23)

    02 Blank (25)

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    01 Valid (10)

    02 Blank (38)

    filter

    01 218MF10100 (1)

    02 218MF10350 (1)

    03 222MF10170 (1)

    04 223MF10034 (1)

    05 224MF10042 (1)

    06 227MF10180 (1)

    07 228MF10055 (1)

    08 228MF10056 (1)

    09 229MF10147 (1)

    10 304MF10075 (1)

    11 Blank (38)

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    01 Blank (48)

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    • FDA
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    Digital Content Digital Content

    Formoterol Fumarate

    PDF Supplier PDF
    URL Supplier Web Content
    Other DMF CN, RU
    See all info for this product

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    USDMF

    Found USDMF

    16628
    Active
    FORMOTEROL FUMARATE
    2003-06-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-024 - Rev 02
    Valid
    Formoterol fumarate dihydrate
    2020-10-15
    Japanese DMF

    Found JDMF

    224MF10042
    Formoterol fumarate hydrate at Area...
    2012-02-28
    Written Confirmation

    Close WC

    Application Number
    16628
    R1-CEP 2006-024 - Rev 02
    224MF10042
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FORMOTEROL FUMARATE
    Formoterol fumarate dihydrate
    Formoterol fumarate hydrate at Area...
    Issue/Submission Date
    2003-06-03
    2020-10-15
    2012-02-28
    Inke Company Banner

    Formulation & Delivery

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    • FDA
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    17346
    Active
    GRANISETRON HYDROCHLORIDE
    2004-04-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-030 - Rev 01
    Valid
    Granisetron hydrochloride
    2016-03-17
    Japanese DMF

    Found JDMF

    218MF10350
    Granisetron hydrochloride at Area I...
    2006-03-17
    Written Confirmation

    Close WC

    Application Number
    17346
    R1-CEP 2008-030 - Rev 01
    218MF10350
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GRANISETRON HYDROCHLORIDE
    Granisetron hydrochloride
    Granisetron hydrochloride at Area I...
    Issue/Submission Date
    2004-04-05
    2016-03-17
    2006-03-17
    Inke Company Banner

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    Fluconazole

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    NA Not Available For Sales
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    USDMF

    Found USDMF

    14714
    Active
    FLUCONAZOLE
    1999-12-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-219 - Rev 02
    Valid
    Fluconazole
    2019-06-14
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    14714
    R1-CEP 2007-219 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLUCONAZOLE
    Fluconazole
    Issue/Submission Date
    1999-12-15
    2019-06-14
    Inke Company Banner

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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    31836
    Active
    GLYCOPYRROLATE
    2017-07-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-182 - Rev 00
    Valid
    Glycopyrronium bromide, Micronised,...
    2023-08-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31836
    R1-CEP 2017-182 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GLYCOPYRROLATE
    Glycopyrronium bromide, Micronised,...
    Issue/Submission Date
    2017-07-22
    2023-08-17
    Inke Company Banner

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    Ondansetron Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16317
    Active
    ONDANSETRON HYDROCHLORIDE
    2002-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-056 - Rev 00
    Valid
    Ondansetron hydrochloride dihydrate
    2012-05-24
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    16317
    R1-CEP 2005-056 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ONDANSETRON HYDROCHLORIDE
    Ondansetron hydrochloride dihydrate
    Issue/Submission Date
    2002-12-13
    2012-05-24
    Inke Company Banner

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    Risperidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15682
    Active
    RISPERIDONE
    2001-10-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-054 - Rev 00
    Valid
    Risperidone
    2012-07-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15682
    R1-CEP 2006-054 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RISPERIDONE
    Risperidone
    Issue/Submission Date
    2001-10-23
    2012-07-16
    Inke Company Banner

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    Salmeterol Xinafoate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23914
    Active
    SALMETEROL XINAFOATE
    2010-06-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-127 - Rev 00
    Valid
    Salmeterol xinafoate
    2014-06-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23914
    R1-CEP 2007-127 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SALMETEROL XINAFOATE
    Salmeterol xinafoate
    Issue/Submission Date
    2010-06-23
    2014-06-16
    Inke Company Banner

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    Tiotropium Bromide

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    USDMF

    Found USDMF

    34410
    Active
    TIOTROPIUM BROMIDE MONOHYDRATE (MIC...
    2020-03-17
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-337 - Rev 01
    Valid
    Tiotropium bromide monohydrate, Mic...
    2023-05-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34410
    R0-CEP 2019-337 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TIOTROPIUM BROMIDE MONOHYDRATE (MIC...
    Tiotropium bromide monohydrate, Mic...
    Issue/Submission Date
    2020-03-17
    2023-05-16
    Inke Company Banner

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    Aclidinium Bromide

    PDF Supplier PDF
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    Other DMF EU
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    USDMF

    Found USDMF

    36437
    Active
    ACLIDINIUM BROMIDE
    2023-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    36437
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ACLIDINIUM BROMIDE
    Issue/Submission Date
    2023-03-16
    Inke Company Banner

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    Aprepitant

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35497
    Active
    APREPITANT
    2022-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    35497
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APREPITANT
    Issue/Submission Date
    2022-04-26
    Inke Company Banner

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