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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by ACS DOBFAR SPA to the Review Authority in Korea.

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    ACS DOBFAR SPA
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    Viale Addetta 4/12 20067 Tribiano (Milan)
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    Avibactam Sodium

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    Pfizer Pharmaceuticals Korea Co., Ltd.
    2022-12-22
    Wed87-31-ND
    ACS Dobfar SpA@Ajinomoto ...
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    Viale Addetta, 2a/12–3/...
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    cefaclor hydrate

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    Aju Pharmaceutical Co., Ltd.
    2019-11-07
    20050831-20-A-17-02(17)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Sungjin Exim Co., Ltd.
    2005-08-31
    20050831-20-A-17-02
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Dongkwang Pharmaceutical Co., Ltd.
    2016-05-27
    20050831-20-A-17-02(16)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Daewoong Pharmaceutical Co., Ltd.
    2011-07-15
    20050831-20-A-17-02(1)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Boryeong Co., Ltd.
    2011-07-15
    20050831-20-A-17-02(2)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Korea Chorus Co., Ltd.
    2012-06-07
    20050831-20-A-17-02(11)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Youngjin Pharmaceutical Co., Ltd.
    2020-03-12
    20050831-20-A-17-02(18)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Daewoong Bio Co., Ltd.
    2014-10-22
    20050831-20-A-17-02(15)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Bijeon Pharmaceutical Co., Ltd.
    2011-09-30
    20050831-20-A-17-02(5)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20871...
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    cefaclor hydrate

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    RP Bio Co., Ltd.
    2013-06-04
    20050831-20-A-17-02(13)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20059...
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    cefaclor hydrate

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    Kookjeon Pharmaceutical Co., Ltd.
    2013-01-24
    20050831-20-A-17-02(12)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Kyungbo Pharmaceutical Co., Ltd.
    2020-05-11
    20050831-20-A-17-02(20)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Kukje Pharmaceutical Co., Ltd.
    2020-04-24
    20050831-20-A-17-02(19)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Ildong Pharmaceutical Co., Ltd.
    2011-08-05
    20050831-20-A-17-02(3)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Hwail Pharmaceutical Co., Ltd.
    2011-08-04
    20050831-20-A-17-02(4)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Kyungdong Pharmaceutical Co., Ltd.
    2014-04-17
    20050831-20-A-17-02(14)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Alvogen Korea Co., Ltd.
    2011-07-29
    20050831-20-A-17-02(6)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefaclor hydrate

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    Korea Union Pharmaceutical Co., Ltd.
    2011-12-15
    20050831-20-A-17-02(9)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20871...
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    cefadroxyl hydrate

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    Daewoong Pharmaceutical Co., Ltd.
    2011-07-15
    20050831-19-A-11-02(1)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefadroxyl hydrate

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    Sungjin Exim Co., Ltd.
    2005-08-31
    20050831-19-A-11-02
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefadroxyl hydrate

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    Boryeong Co., Ltd.
    2011-07-15
    20050831-19-A-11-02(2)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefadroxyl hydrate

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    Daewoong Bio Co., Ltd.
    2019-04-01
    20050831-19-A-11-02(9)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20871...
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    cefadroxyl hydrate

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    Chong Kun Dang Co., Ltd.
    2011-10-07
    20050831-19-A-11-02(5)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20871...
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    cefadroxyl hydrate

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    Korea United Pharmaceutical Co., Ltd.
    2012-03-16
    20050831-19-A-11-02(6)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20871...
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    cefadroxyl hydrate

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    Kukje Pharmaceutical Co., Ltd.
    2016-08-24
    20050831-19-A-11-02(8)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefadroxyl hydrate

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    Hwail Pharmaceutical Co., Ltd.
    2011-08-12
    20050831-19-A-11-02(3)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefadroxyl hydrate

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    Korea Chorus Co., Ltd.
    2012-12-21
    20050831-19-A-11-02(7)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    Cefazolin Sodium

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    Sungjin Exim Co., Ltd.
    2021-04-27
    20210427-210-J-635
    ACS Dobfar SpA
    Italy
    Viale Addetta, 2a/12-3/5 ...
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    Cefepime hydrochloride

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    Boryeong Co., Ltd.
    2011-04-14
    20080331-84-D-64-02(1)
    Antibiotics do Brasil Ltd...
    Brazil
    Rodovia Professor Zeferin...
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    Cefepime hydrochloride hydrate

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    BC World Pharmaceutical Co., Ltd.
    2018-05-29
    20180208-84-D-143-10(1)
    Antibiotics do Brasil Ltd...
    Brazil
    Rodovia Professor Zeferio...
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    Cefepime hydrochloride hydrate

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    Youngjin Pharmaceutical Co., Ltd.
    2020-07-02
    20180208-84-D-143-10(2)
    Antibiotics do Brasil Ltd...
    Brazil
    Rodovia Professor Zeferio...
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    Cefepime hydrochloride hydrate

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    Daewoong Bio Co., Ltd.
    2022-06-15
    20080331-84-D-64-02(3)
    Antibiotics do Brasil Ltd...
    Brazil
    Rodovia Professor Zeferin...
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    Cefepime hydrochloride hydrate

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    Sungjin Exim Co., Ltd.
    2018-02-08
    20180208-84-D-143-10
    Antibiotics do Brasil Ltd...
    Brazil
    Rodovia Professor Zeferin...
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    Cefepime hydrochloride hydrate

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    Sungjin Exim Co., Ltd.
    2008-03-31
    20080331-84-D-64-02
    Antibiotics do Brasil Ltd...
    Brazil
    Rodovia Professor Zeferin...
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    cefotetan

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    Sungjin Exim Co., Ltd.
    2022-06-15
    20220615-210-J-1316
    ACS DOBFAR SPA
    Italy
    Via Marzabotto 1,7/9 – ...
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    cefprozyl hydrate

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    Youngjin Pharmaceutical Co., Ltd.
    2019-05-02
    20181101-209-J-49(2)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefprozyl hydrate

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    Sungjin Exim Co., Ltd.
    2018-11-01
    20181101-209-J-49
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    cefprozyl hydrate

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    Yuhan Corporation
    2019-04-10
    20181101-209-J-49(1)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    Cefradine

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    Korea Chorus Co., Ltd.
    2013-03-14
    20050831-23-A-35-03(8)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 20...
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    Cefradine

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    JW Pharmaceutical Co., Ltd.
    2011-08-05
    20050831-23-A-35-03(3)
    ACS DOBFAR SPA
    Italy
    Via Marzabotto, 7/9 20871...
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    Cefradine

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    Hwail Pharmaceutical Co., Ltd.
    2011-07-29
    20050831-23-A-35-03(2)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 20...
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    Cefradine hydrate

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    Sungjin Exim Co., Ltd.
    2005-08-31
    20050831-23-A-35-03
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    Cefradine hydrate

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    Boryeong Co., Ltd.
    2011-09-02
    20050831-23-A-35-03(5)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 20...
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    Cefradine hydrate

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    Aju Pharmaceutical Co., Ltd.
    2012-08-17
    20050831-23-A-35-03(6)
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 7/9 20871...
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    Ceftazidime hydrate, dried sodium carbonate

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    Pfizer Pharmaceuticals Korea Co., Ltd.
    2022-12-22
    20221222-210-J-1424
    ACS Dobfar SpA@ACS DOBFAR...
    Italy
    Viale Addetta, 2a/12–3/...
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    Ceftolozane sulfate

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    MSD Korea Co., Ltd.
    2016-11-18
    Wed 90-19-ND
    ACS DOBFAR SpA
    Italy
    Via Marzabotto, 1, 7/9 - ...
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    Cilastatin sodium

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    Hitech Farm Co., Ltd.
    2020-10-15
    20201015-210-J-652
    ACS Dobfar SPA@[Cilastati...
    Italy
    Viale Addetta, 2a/12-3/5 ...
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    Cilastatin sodium

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    Sungjin Exim Co., Ltd.
    2021-07-19
    20201015-210-J-652(1)
    ACS Dobfar SpA@[Cilastati...
    Italy
    Viale Addetta, 2a/12-3/5 ...
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    Daptomycin

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    MSD Korea Co., Ltd.
    2007-05-04
    38-2-ND
    ACS Dobfar SpA. ACSD 6 (A...
    Italy
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