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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Erregierre Spa

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    01 Acebutolol Hydrochloride (1)

    02 Ambroxol Hydrochloride (1)

    03 Amisulpride (1)

    04 Aripiprazole (1)

    05 Arlitene (1)

    06 Atenolol (1)

    07 Baclofen (1)

    08 Bepridil (1)

    09 Bifonazole (1)

    10 Bisacodyl (1)

    11 Bupropion Hydrobromide (1)

    12 Bupropion Hydrochloride (1)

    13 Butenafine Hydrochloride (1)

    14 Camostat (1)

    15 Camostatum (1)

    16 Carprofen (1)

    17 Celecoxib (1)

    18 Chenodeoxycholic Acid (2)

    19 Ciclopirox (1)

    20 Ciclopirox Olamine (1)

    21 Clotrimazole (1)

    22 Deferasirox (1)

    23 Dipyridamole (1)

    24 Duloxetine (1)

    25 Econazole Nitrate (2)

    26 Eltrombopag (1)

    27 Entacapone (1)

    28 Etoricoxib (1)

    29 Fluoxetine Hydrochloride (1)

    30 Flurbiprofen (1)

    31 Gabapentin (2)

    32 Gepirone (1)

    33 Ingavirin (1)

    34 Isoconazole (1)

    35 Isoconazole Nitrate (1)

    36 Isoxsuprine Hydrochloride (1)

    37 Labetalol Hydrochloride (1)

    38 Mebhydroline Napadisylate (1)

    39 Mesalazine (2)

    40 Metoprolol Tartrate (2)

    41 Miconazole (1)

    42 Miconazole Nitrate (1)

    43 Moclobemide (1)

    44 NAFTIFINE HCL (1)

    45 Nabumetone (2)

    46 Nimesulide (1)

    47 Nisoldipine (1)

    48 Opipramol (1)

    49 Oxaprozin (1)

    50 Oxiconazole Nitrate (1)

    51 Ozagrel Hydrochloride (1)

    52 Ozagrel Sodium (1)

    53 P-Trifluoromethylbenzyl Bromide (1)

    54 Pantoprazole Sodium (1)

    55 Phenylpiracetam (1)

    56 Pioglitazone Hydrochloride (1)

    57 Pramipexole Dihydrochloride (1)

    58 Propafenone Hydrochloride (1)

    59 Racecadotril (1)

    60 Raloxifene Hydrochloride (1)

    61 Risperidone (1)

    62 Rivaroxaban (1)

    63 Rivastigmine (1)

    64 Rivastigmine Tartrate (1)

    65 Sotalol Hydrochloride (1)

    66 Sulconazole Nitrate (1)

    67 Terfenadine (1)

    68 Tiaprofenic Acid (1)

    69 Ticlopidine (1)

    70 Tioconazole (1)

    71 Tolterodine Tartrate (1)

    72 Trazodone Hydrochloride (1)

    73 Urapidil Hydrochloride (1)

    74 Ursodeoxycholic Acid (1)

    75 Zileuton (1)

    76 Blank (1)

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    01 Active (27)

    02 Inactive (32)

    03 Blank (23)

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    01 Valid (15)

    02 Withdrawn by Holder (2)

    03 Blank (65)

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    01 217MF10586 (1)

    02 217MF10587 (1)

    03 217MF10589 (1)

    04 217MF11176 (1)

    05 219MF10010 (1)

    06 219MF10065 (1)

    07 220MF10204 (1)

    08 220MF10232 (1)

    09 221MF10064 (1)

    10 221MF10279 (1)

    11 226MF10007 (1)

    12 228MF10192 (1)

    13 229MF10164 (1)

    14 304MF10127 (1)

    15 Blank (68)

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    01 Blank (82)

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    Mesalazine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13883
    Active
    MESALAMINE USP-EP
    1998-12-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-049 - Rev 04
    Valid
    Mesalazine
    2019-10-03
    Japanese DMF

    Found JDMF

    221MF10064
    Mesalazine at VIA F. BARACCA 19-240...
    2009-03-26
    Written Confirmation

    Close WC

    Application Number
    13883
    R1-CEP 2004-049 - Rev 04
    221MF10064
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP-EP
    Mesalazine
    Mesalazine at VIA F. BARACCA 19-240...
    Issue/Submission Date
    1998-12-03
    2019-10-03
    2009-03-26
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    Mesalazine

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    USDMF

    Found USDMF

    24889
    Active
    MESALAMINE USP - PH.EUR. (HIGH DENS...
    2011-04-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-322 - Rev 00
    Valid
    Mesalazine, High density
    2017-10-30
    Japanese DMF

    Found JDMF

    219MF10065
    Mesalazine at VIA F. BARACCA 19-240...
    2007-03-05
    Written Confirmation

    Close WC

    Application Number
    24889
    R1-CEP 2011-322 - Rev 00
    219MF10065
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE USP - PH.EUR. (HIGH DENS...
    Mesalazine, High density
    Mesalazine at VIA F. BARACCA 19-240...
    Issue/Submission Date
    2011-04-26
    2017-10-30
    2007-03-05
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    Raloxifene Hydrochloride

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    USDMF

    Found USDMF

    15932
    Active
    RALOXIFENE HYDROCHLORIDE
    2002-04-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-205 - Rev 00
    Valid
    Raloxifene hydrochloride
    2017-09-06
    Japanese DMF

    Found JDMF

    226MF10007
    Raloxifene Hydrochloride at VIA F. ...
    2014-01-08
    Written Confirmation

    Close WC

    Application Number
    15932
    R1-CEP 2010-205 - Rev 00
    226MF10007
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RALOXIFENE HYDROCHLORIDE
    Raloxifene hydrochloride
    Raloxifene Hydrochloride at VIA F. ...
    Issue/Submission Date
    2002-04-10
    2017-09-06
    2014-01-08
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    Ambroxol Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-117 - Rev 02
    Valid
    Ambroxol hydrochloride
    2020-07-10
    Japanese DMF

    Found JDMF

    219MF10010
    Outsiders regulations ambroxol hydr...
    2007-01-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-117 - Rev 02
    219MF10010
    Status
    Valid
     
    Filing Details
    Ambroxol hydrochloride
    Outsiders regulations ambroxol hydr...
    Issue/Submission Date
    2020-07-10
    2007-01-18
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    Bifonazole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-241 - Rev 00
    Valid
    Bifonazole
    2019-12-05
    Japanese DMF

    Found JDMF

    221MF10279
    Bifonazole (production only) at Via...
    2009-12-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-241 - Rev 00
    221MF10279
    Status
    Valid
     
    Filing Details
    Bifonazole
    Bifonazole (production only) at Via...
    Issue/Submission Date
    2019-12-05
    2009-12-18
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    Bisacodyl

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    USDMF

    Found USDMF

    14947
    Active
    BISACODYL USP-EP
    2000-06-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-233 - Rev 00
    Valid
    Bisacodyl, Micronised
    2022-03-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14947
    R0-CEP 2020-233 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BISACODYL USP-EP
    Bisacodyl, Micronised
    Issue/Submission Date
    2000-06-29
    2022-03-01
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    Ciclopirox

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    USDMF

    Found USDMF

    16353
    Active
    CICLOPIROX USP-EP
    2002-12-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-210 - Rev 03
    Valid
    Ciclopirox
    2019-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16353
    R1-CEP 2002-210 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CICLOPIROX USP-EP
    Ciclopirox
    Issue/Submission Date
    2002-12-30
    2019-03-07
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    Ciclopirox Olamine

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    USDMF

    Found USDMF

    16352
    Active
    CICLOPIROX OLAMINE USP-PH.EUR.
    2003-01-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-065 - Rev 04
    Valid
    Ciclopirox olamine
    2022-08-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16352
    R1-CEP 2002-065 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CICLOPIROX OLAMINE USP-PH.EUR.
    Ciclopirox olamine
    Issue/Submission Date
    2003-01-02
    2022-08-29
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    Clotrimazole

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    USDMF

    Found USDMF

    6324
    Active
    CLOTRIMAZOLE USP-EP
    1986-03-01
    CEP/COS

    Found CEP/COS

    CEP 2005-176 - Rev 03
    Valid
    Clotrimazole
    2024-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6324
    CEP 2005-176 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CLOTRIMAZOLE USP-EP
    Clotrimazole
    Issue/Submission Date
    1986-03-01
    2024-01-31
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    Isoconazole Nitrate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-282 - Rev 01
    Valid
    Isoconazole nitrate, Standard and m...
    2023-10-18
    Japanese DMF

    Found JDMF

    217MF10587
    Nitric acid isoconazole at VIA F. B...
    2005-09-14
    Written Confirmation

    Close WC

    Application Number
    CEP 2014-282 - Rev 01
    217MF10587
    Status
    Valid
     
    Filing Details
    Isoconazole nitrate, Standard and m...
    Nitric acid isoconazole at VIA F. B...
    Issue/Submission Date
    2023-10-18
    2005-09-14
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