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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by F.I.S. Fabbrica Italiana Sintetici to the Review Authority in Korea.

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    F.I.S. Fabbrica Italiana Sintetici
    Italy Flag
    Country
    Country
    Italy
    Address
    Address
    Viale Milano, 26, 36075 Montecchio, Maggiore, Vicenza (Italy)
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    Telephone
    +39-044-470-8011
    Client Email
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    enquiries@pharmacompass.com
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    Website
    https://www.fisvi.com/it
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    Linkedin
    https://www.linkedin.com/company/f-i-s---fabbrica-italiana-sintetici/
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    • FDA
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    Bazedoxifene acetate

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    Pfizer Pharmaceuticals Korea Co., Ltd.
    2011-10-21
    Wed189-13-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Via Dovaro, snc - 36045 L...
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    Bromazepam

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    Samo Pharmaceutical Co., Ltd.
    2021-04-16
    20210416-209-J-848
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 MO...
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    Carbamazepine

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    Samo Pharmaceutical Co., Ltd.
    2018-08-24
    20180824-209-J-109
    FIS FABBRICA ITALIANA SIN...
    Italy
    Via Massimo D'Antona, 13 ...
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    Chlordiazepoxide

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    Samo Pharmaceutical Co., Ltd.
    2021-05-04
    20210504-209-J-978
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 MO...
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    Dorzolamide hydrochloride

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    Bausch Health Korea Co., Ltd.
    2023-06-08
    20230608-209-J-1508
    FIS Fabbrica Italiana Sin...
    Italy
    Via Dovaro, snc-36045 Lon...
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    Dorzolamide hydrochloride

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    Classia Co., Ltd.
    2021-09-16
    20210916-209-J-969
    FIS - Fabbrica Italiana S...
    Italy
    Via Dovaro, snc - 36045 L...
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    Edoxabantosylate hydrate

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    Daiichi Sankyo Korea Co., Ltd.
    2023-12-01
    Number 256-5-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26 Montecch...
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    Efavi Lens

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    MSD Korea Co., Ltd.
    2009-04-29
    Number 906-8-ND
    FIS-Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26 36075 Mo...
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    Elvitegravir

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    Gilead Sciences Korea Ltd.
    2016-06-29
    Number 6273-7-ND
    FIS - Fabbrica Italiana S...
    Italy
    Viale Milano 26, 36075 Mo...
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    Esomeprazole Magnesium Dihydrate

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    Samo Pharmaceutical Co., Ltd.
    2014-09-19
    20140919-127-H-367-16
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 MO...
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    Esomeprazole Magnesium Dihydrate

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    Korea United Pharmaceutical Co., Ltd.
    2016-08-24
    20140919-127-H-367-16(1)
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 MO...
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    Etoricoxib

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    Korea Organon Co., Ltd.
    2014-12-23
    Number 3281-15-ND
    FIS-Fabbrica Italiana Sin...
    Italy
    Via Massimo D'Antoná 13 ...
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    finasteride

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    Korea Organon Co., Ltd.
    2013-06-18
    20130618-94-E-105-09
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26, 36075 M...
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    flunitrazepam

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    Samo Pharmaceutical Co., Ltd.
    2021-06-22
    20210622-209-J-849
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 MO...
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    Gabapentin

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    Alvogen Korea Co., Ltd.
    2023-03-10
    20120725-142-I-66-04(A)
    FIS Fabbrica Italiana Sin...
    Italy
    Via Dovaro, snc-36045 Lon...
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    Gabapentin

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    Beatrice Korea Co., Ltd.
    2012-07-25
    20120725-142-I-66-04
    FIS Fabbrica Italiana Sin...
    Italy
    Via Dovaro, snc 36045 Lon...
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    Imatinib Mesylate

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    Novartis Korea Co., Ltd.
    2022-10-18
    Wed196-24-ND
    FIS FABBRICA ITALIANA SIN...
    Italy
    Via Massimo D'Antona, 13,...
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    Lansoprazole

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    Jeil Pharmaceutical Co., Ltd.
    2010-06-30
    20100630-3-B-299-09
    FIS FABBRICA ITALIANA SIN...
    Italy
    Viale Milano, 26, 36075 M...
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    Mycophenolate mofetil

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    Korea Roche Co., Ltd.
    2020-09-15
    20200915-209-J-701
    FIS Fabbrica Italiana Sin...
    Italy
    Via Massimo D'Antona, 13 ...
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    Nebivolol hydrochloride

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    Hiple Co., Ltd.
    2012-03-09
    20120309-178-I-47-01
    FIS FABBRICA ITALIANA SIN...
    Italy
    Chemical Plant Via Dovaro...
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    nifedipine

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    Kwangdong Pharmaceutical Co., Ltd.
    2011-09-02
    20110902-134-H-31-04
    FIS Fabbrica Italiana Sin...
    Italy
    Via Dovaro 36045 Lonigo@[...
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    olopatadine hydrochloride

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    Ace Biopharm Co., Ltd.
    2021-03-30
    20210330-209-J-913
    FIS-Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26 Alte di ...
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    Oxcarbazepine

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    Novartis Korea Co., Ltd.
    2021-03-10
    20210310-209-J-869
    FIS FABBRICA ITALIANA SIN...
    Italy
    Via Massimo D'Antona, 13 ...
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    Oxcarbazepine

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    Samo Pharmaceutical Co., Ltd.
    2021-08-19
    20210819-209-J-1092
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 MO...
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    Pazopanib hydrochloride

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    Novartis Korea Co., Ltd.
    2023-07-12
    Wed196-26-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26, 36075 M...
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    • FDA
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    Perampanel

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    Korea Eisai Co., Ltd.
    2020-06-25
    Number 140-7-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26 - 36075 ...
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    Remdesivir

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    Gilead Sciences Korea Ltd.
    2020-07-24
    Wed205-17-ND
    Fabbrica Italiana Sinteti...
    Italy
    Viale Milano, 26 Montecch...
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    Rifaximin

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    Samo Pharmaceutical Co., Ltd.
    2022-04-27
    20220427-209-J-1280
    FIS Fabbrica Italiana Sin...
    Italy
    Via Dovaro, snc - 36045 L...
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    Sitagliptin phosphate hydrate

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    MSD Korea Co., Ltd.
    2013-12-10
    Number 3281-13-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26 - 36075 ...
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    Sugammadex Sodium

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    MSD Korea Co., Ltd.
    2023-11-30
    Wed90-31-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26 - 36075 ...
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    vildagliptin

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    Novartis Korea Co., Ltd.
    2020-07-07
    Wed196-19-ND
    FIS Fabbrica Italiana Sin...
    Italy
    Viale Milano, 26-36075 Mo...
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    • FDA
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    facebooksostart

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    SK Chemicals Co., Ltd.
    2008-06-27
    Number 4827-3-ND
    Fabbrica Italiana Sinteti...
    Italy
    Viale Milano 26, 36075 Mo...
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