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

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    Mallinckrodt Pharmaceuticals
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    College Business & Technology Park Cruiserath, Blanchardstown Dublin 15
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    +353 1 6960000
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    enquiries@pharmacompass.com
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    https://www.mallinckrodt.com/
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    https://www.linkedin.com/company/mallinckrodt/
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    • FDA
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    Acetaminophen

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    GlaxoSmithKline Consumer Healthcare Korea Co., Ltd.
    2009-12-24
    20091224-32-C-266-16
    Mallinckrodt Inc.
    U.S.A
    Greenville Plant, Covidie...
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    Acetaminophen

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    Korea Johnson & Johnson Sales Co., Ltd.
    2023-01-10
    20050831-32-C-126-07(A)
    SpecGx LLC
    U.S.A
    8801 Capital Boulevard, R...
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    Acetaminophen

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    Korea Janssen Co., Ltd.
    2005-08-31
    20050831-32-C-126-07
    SpecGx LLC
    U.S.A
    8801 Capital Boulevard, R...
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    Acetaminophen

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    Korea Janssen Co., Ltd.
    2005-08-31
    20050831-32-C-125-06
    SpecGx LLC@[Name of granu...
    Ireland
    8801 Capital Boulevard, R...
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    • FDA
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    Acetaminophen

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    Sama Pharmaceutical Co., Ltd.
    2011-10-21
    20050831-32-C-126-07(3)
    Spec Gx LLC
    U.S.A
    8801 Capital Boulevard Ra...
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    Acetaminophen

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    Korea Johnson & Johnson Sales Co., Ltd.
    2009-06-26
    20090626-32-C-261-14
    SpecGx LLC
    U.S.A
    8801 Capital Boulevard, R...
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    Acetaminophen

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    Leesung International Co., Ltd.
    2020-07-01
    20050831-32-C-126-07(4)
    SpecGx LLC
    U.S.A
    8801 Capital Boulevard, R...
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    Acetaminophen

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    Hwail Pharmaceutical Co., Ltd.
    2011-06-15
    20050831-32-C-126-07(2)
    SpecGx LLC
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    8801 Capital Boulevard, R...
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    Acetaminophen

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    Agerson Bio Co., Ltd.
    2022-06-10
    20050831-32-C-126-07(5)
    SpecGx LLC
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    8801 Capital Boulevard, R...
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    Acetaminophen

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    Wonpoong Pharmaceutical Co., Ltd.
    2011-05-16
    20050831-32-C-126-07(1)
    SpecGx LLC
    U.S.A
    8801 Capital Boulevard, R...
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    exenatide

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    AstraZeneca Korea Co., Ltd.
    2008-02-05
    Number 51-4-ND
    Mallinckrodt Inc.
    U.S.A
    3600 N. Second Street PO ...
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    fentanyl

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    Nosa Chemical Co., Ltd.
    2022-11-28
    20221128-211-J-1415
    SpecGx LLC
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    3600 North 2nd Street, St...
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    hydrocodone tartrate

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    Nosa Chemical Co., Ltd.
    2022-05-25
    20220525-211-J-1305
    SpecGx LLC
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    3600 North 2nd Street, St...
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    Methylphenidate hydrochloride

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    Korea Pharma Co., Ltd.
    2023-10-26
    20231012-209-J-1551(A)
    SpecGx LLC
    U.S.A
    3600 North Second Street,...
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    Methylphenidate hydrochloride

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    Alvogen Korea Co., Ltd.
    2023-10-12
    20231012-209-J-1551
    SpecGx LLC
    U.S.A
    3600 North Second Street,...
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    naltrexone hydrochloride

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    Leesung International Co., Ltd.
    2021-03-31
    20210331-209-J-569
    SpecGx LLC
    U.S.A
    3600 North Second Street,...
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    nitric oxide

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    Sinex Co., Ltd.
    2009-02-16
    Number 693-1-ND
    Mallinckrodt Manufacturin...
    U.S.A
    1060 Allendale Drive, Por...
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    Sufentanyl citrate

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    Nosa Chemical Co., Ltd.
    2022-05-18
    20220518-210-J-1301
    SpecGx LLC
    U.S.A
    3600 North 2nd Street, St...
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