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

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    01 Aripiprazole (1)

    02 Benznidazole (1)

    03 Cariprazine Hydrochloride (1)

    04 Diltiazem Hydrochloride (1)

    05 Enalapril Maleate (2)

    06 Fingolimod Hydrochloride (1)

    07 Flecainide (3)

    08 Ketorolac Trometamol (1)

    09 Leflunomide (1)

    10 Losartan Potassium (1)

    11 Nicardipine Hydrochloride (1)

    12 Nitazoxanide (1)

    13 Ozanimod (1)

    14 Ranitidine Hydrochloride (1)

    15 Rasagiline Mesylate (1)

    16 Sildenafil Citrate (1)

    17 Tamsulosin (1)

    18 Teriflunomide (1)

    19 Zoledronic Acid (1)

    20 Blank (2)

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    01 Active (10)

    02 Inactive (13)

    03 Blank (1)

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    01 Valid (6)

    02 Blank (18)

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    01 Blank (24)

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    01 Blank (24)

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    • FDA
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28322
    Active
    FINGOLIMOD HYDROCHLORIDE (CODE 5099...
    2014-07-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-312 - Rev 00
    Valid
    Fingolimod hydrochloride
    2021-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    28322
    R0-CEP 2020-312 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FINGOLIMOD HYDROCHLORIDE (CODE 5099...
    Fingolimod hydrochloride
    Issue/Submission Date
    2014-07-08
    2021-10-28
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    Flecainide

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    USDMF

    Found USDMF

    10688
    Active
    FLECAINIDE ACETATE PROCESS I (CODE ...
    1994-01-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-055 - Rev 03
    Valid
    Flecainide acetate
    2022-04-01
    Japanese DMF

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    Application Number
    10688
    R1-CEP 2010-055 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLECAINIDE ACETATE PROCESS I (CODE ...
    Flecainide acetate
    Issue/Submission Date
    1994-01-24
    2022-04-01
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    Leflunomide

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    USDMF

    Found USDMF

    32988
    Active
    LEFLUNOMIDE
    2018-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-252 - Rev 01
    Valid
    Leflunomide
    2022-10-27
    Japanese DMF

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    Application Number
    32988
    R0-CEP 2018-252 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEFLUNOMIDE
    Leflunomide
    Issue/Submission Date
    2018-09-07
    2022-10-27
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    Teriflunomide

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    USDMF

    Found USDMF

    36622
    Active
    TERIFLUNOMIDE
    2021-12-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-005 - Rev 00
    Valid
    Teriflunomide
    2023-05-05
    Japanese DMF

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    Application Number
    36622
    R0-CEP 2022-005 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TERIFLUNOMIDE
    Teriflunomide
    Issue/Submission Date
    2021-12-22
    2023-05-05
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    Flecainide

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    USDMF

    Caution USDMF

    24309
    Inactive
    FLECAINIDE ACETATE PROCESS II (CODE...
    2010-10-13
    CEP/COS

    Found CEP/COS

    CEP 2013-145 - Rev 02
    Valid
    Flecainide acetate, Code 50970
    2023-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    24309
    CEP 2013-145 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FLECAINIDE ACETATE PROCESS II (CODE...
    Flecainide acetate, Code 50970
    Issue/Submission Date
    2010-10-13
    2023-12-05
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    Cariprazine Hydrochloride

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    USDMF

    Found USDMF

    33623
    Active
    CARIPRAZINE HYDROCHLORIDE
    2019-03-22
    CEP/COS

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    Application Number
    33623
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARIPRAZINE HYDROCHLORIDE
    Issue/Submission Date
    2019-03-22
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    Flecainide

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    USDMF

    Found USDMF

    28158
    Active
    FLECAINIDE ACETATE PROCESS III (COD...
    2014-05-15
    CEP/COS

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    Japanese DMF

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    Application Number
    28158
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FLECAINIDE ACETATE PROCESS III (COD...
    Issue/Submission Date
    2014-05-15
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    Nitazoxanide

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    USDMF

    Found USDMF

    34150
    Active
    NITAZOXANIDE
    2019-12-18
    CEP/COS

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    Japanese DMF

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    Application Number
    34150
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NITAZOXANIDE
    Issue/Submission Date
    2019-12-18
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    Ozanimod

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    USDMF

    Found USDMF

    38622
    Active
    OZANIMOD HYDROCHLORIDE
    2023-09-22
    CEP/COS

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    Application Number
    38622
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OZANIMOD HYDROCHLORIDE
    Issue/Submission Date
    2023-09-22
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    Rasagiline Mesylate

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    USDMF

    Found USDMF

    25366
    Active
    RASAGILINE MESYLATE (CODE 50855)
    2011-10-06
    CEP/COS

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    Application Number
    25366
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RASAGILINE MESYLATE (CODE 50855)
    Issue/Submission Date
    2011-10-06
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