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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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    01 Bazedoxifene acetate (1)

    02 Bromazepam (1)

    03 Carbamazepine (1)

    04 Chlordiazepoxide (1)

    05 Dorzolamide hydrochloride (2)

    06 Edoxabantosylate hydrate (1)

    07 Efavi Lens (1)

    08 Elvitegravir (1)

    09 Esomeprazole Magnesium Dihydrate (2)

    10 Etoricoxib (1)

    11 Gabapentin (2)

    12 Imatinib Mesylate (1)

    13 Lansoprazole (1)

    14 Mycophenolate mofetil (1)

    15 Nebivolol hydrochloride (1)

    16 Oxcarbazepine (2)

    17 Pazopanib hydrochloride (1)

    18 Perampanel (1)

    19 Remdesivir (1)

    20 Rifaximin (1)

    21 Sitagliptin phosphate hydrate (1)

    22 Sugammadex Sodium (1)

    23 facebooksostart (1)

    24 finasteride (1)

    25 flunitrazepam (1)

    26 nifedipine (1)

    27 olopatadine hydrochloride (1)

    28 vildagliptin (1)

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    01 Ace Biopharm Co., Ltd. (1)

    02 Alvogen Korea Co., Ltd. (1)

    03 Bausch Health Korea Co., Ltd. (1)

    04 Beatrice Korea Co., Ltd. (1)

    05 Classia Co., Ltd. (1)

    06 Daiichi Sankyo Korea Co., Ltd. (1)

    07 Gilead Sciences Korea Ltd. (2)

    08 Hiple Co., Ltd. (1)

    09 Jeil Pharmaceutical Co., Ltd. (1)

    10 Korea Eisai Co., Ltd. (1)

    11 Korea Organon Co., Ltd. (2)

    12 Korea Roche Co., Ltd. (1)

    13 Korea United Pharmaceutical Co., Ltd. (1)

    14 Kwangdong Pharmaceutical Co., Ltd. (1)

    15 MSD Korea Co., Ltd. (3)

    16 Novartis Korea Co., Ltd. (4)

    17 Pfizer Pharmaceuticals Korea Co., Ltd. (1)

    18 SK Chemicals Co., Ltd. (1)

    19 Samo Pharmaceutical Co., Ltd. (7)

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    01 FIS - Fabbrica Italiana Sintetici SpA (2)

    02 FIS FABBRICA ITALIANA SINTETICI SPA (4)

    03 FIS FABBRICA ITALIANA SINTETICI SPA@FIS FABBRICA ITALIANA SINTETICI SPA (1)

    04 FIS Fabbrica Italiana Sintetici SPA (3)

    05 FIS Fabbrica Italiana Sintetici SpA (14)

    06 FIS Fabbrica Italiana Sintetici SpA@Catalent Micron Technologies Limited (1)

    07 FIS Fabbrica Italiana Sintetici SpA@Micro-Macinazione SA (1)

    08 FIS Fabbrica Italiana Sintetici SpA@[micronization process manufacturing plant] Micro-Macinazione SA (1)

    09 FIS-Fabbrica Italiana Sintetici (1)

    10 FIS-Fabbrica Italiana Sintetici SpA (1)

    11 FIS-Fabbrica Italiana Sintetici SpA@[Partial process consignment manufacturing] FIS Fabbrica Italiana Sintetici SpA (1)

    12 Fabbrica Italiana Sintetici (FIS) SpA (1)

    13 Fabbrica Italiana Sintetici SpA (1)

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    01 Italy (32)

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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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    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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