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    List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to F.i.s. Fabbrica Italiana Sintetici by EDQM. Original Data: EDQM Database

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    01 Acetylcysteine (1)

    02 Bromazepam (1)

    03 Carbamazepine (1)

    04 Chlordiazepoxide (1)

    05 Chlordiazepoxide hydrochloride (1)

    06 Chlordiazepoxide hydrochloride, Process 2 (1)

    07 Clonazepam, Non-micronised, micronised (1)

    08 Clotrimazole, Standard and micronised grade (1)

    09 Diazepam (1)

    10 Diltiazem hydrochloride (1)

    11 Dorzolamide hydrochloride (1)

    12 Entacapone (1)

    13 Esomeprazole magnesium dihydrate (1)

    14 Flunitrazepam (1)

    15 Flunitrazepam, Process 2 (1)

    16 Flurazepam monohydrochloride (1)

    17 Fosfomycin trometamol (1)

    18 Furosemide (1)

    19 Gabapentin (1)

    20 Imatinib mesilate (1)

    21 Indometacin, Micronised, non-micronised (1)

    22 Lorazepam (1)

    23 Midazolam (1)

    24 Nifedipine (1)

    25 Nitrazepam (1)

    26 Nitrofurantoin (1)

    27 Nitrofurantoin, Macrocrystals (1)

    28 Oxazepam (1)

    29 Oxcarbazepine, Process A (1)

    30 Oxcarbazepine, Process M (1)

    31 Progesterone (1)

    32 Propofol (1)

    33 Rifaximin, Form α (1)

    34 Testosterone propionate (1)

    35 Tetrazepam (1)

    36 Tetrazepam, Process 2 (1)

    37 Tramazoline hydrochloride monohydrate (1)

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    01 F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT (28)

    02 F.I.S. - Fabbrica Italiana Sintetici S.p.A. Montecchio Maggiore IT (9)

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    01 Italy (37)

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    01 Valid (33)

    02 Withdrawn by Holder (4)

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    Acetylcysteine

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    F.I.S. - FABBRICA ITALI...
    Valid
    R1-CEP 1996-070 - Rev 09
    Chemical
    2021-07-23
    967
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    Bromazepam

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    F.I.S. - FABBRICA ITALI...
    Valid
    R1-CEP 2004-034 - Rev 02
    Chemical
    2014-02-24
    879
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    Carbamazepine

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    F.I.S. - FABBRICA ITALI...
    Valid
    R1-CEP 2003-271 - Rev 05
    Chemical
    2022-02-25
    543
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    Chlordiazepoxide

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    F.I.S. - FABBRICA ITALI...
    Valid
    R1-CEP 2001-423 - Rev 02
    Chemical
    2014-02-24
    656
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    Chlordiazepoxide hydrochloride

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    F.I.S. - FABBRICA ITALI...
    Valid
    R1-CEP 2001-417 - Rev 03
    Chemical
    2016-10-28
    474
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    Chlordiazepoxide hydrochloride, Process 2

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    F.I.S. - Fabbrica Itali...
    Valid
    R1-CEP 2014-087 - Rev 01
    Chemical
    2023-04-05
    474
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    Clonazepam, Non-micronised, micronised

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    F.I.S. - Fabbrica Itali...
    Valid
    R1-CEP 2013-037 - Rev 01
    Chemical
    2022-11-23
    890
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    Clotrimazole, Standard and micronised grade

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    F.I.S. - Fabbrica Itali...
    Valid
    R1-CEP 2008-326 - Rev 02
    Chemical
    2022-06-22
    757
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    Diazepam

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    F.I.S. - Fabbrica Itali...
    Valid
    R1-CEP 2003-272 - Rev 03
    Chemical
    2023-04-17
    22
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    Diltiazem hydrochloride

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    F.I.S. - FABBRICA ITALI...
    Valid
    R1-CEP 1998-036 - Rev 07
    Chemical
    2022-03-15
    1004
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