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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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    01 Acetaminophen (10)

    02 Methylphenidate hydrochloride (2)

    03 Sufentanyl citrate (1)

    04 exenatide (1)

    05 fentanyl (1)

    06 hydrocodone tartrate (1)

    07 naltrexone hydrochloride (1)

    08 nitric oxide (1)

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    01 Agerson Bio Co., Ltd. (1)

    02 Alvogen Korea Co., Ltd. (1)

    03 AstraZeneca Korea Co., Ltd. (1)

    04 GlaxoSmithKline Consumer Healthcare Korea Co., Ltd. (1)

    05 Hwail Pharmaceutical Co., Ltd. (1)

    06 Korea Janssen Co., Ltd. (2)

    07 Korea Johnson & Johnson Sales Co., Ltd. (2)

    08 Korea Pharma Co., Ltd. (1)

    09 Leesung International Co., Ltd. (2)

    10 Nosa Chemical Co., Ltd. (3)

    11 Sama Pharmaceutical Co., Ltd. (1)

    12 Sinex Co., Ltd. (1)

    13 Wonpoong Pharmaceutical Co., Ltd. (1)

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    01 Mallinckrodt Inc. (2)

    02 Mallinckrodt Manufacturing LLC (1)

    03 Spec Gx LLC (1)

    04 SpecGx LLC (13)

    05 SpecGx LLC@[Name of granulation process factory] ADARE PHARMACEUTICALS INC._x000D_ (1)

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    01 Ireland (1)

    02 U.S.A (17)

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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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    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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    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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    Sama Pharmaceutical Co., Ltd.
    2011-10-21
    20050831-32-C-126-07(3)
    Spec Gx LLC
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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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    Leesung International Co., Ltd.
    2020-07-01
    20050831-32-C-126-07(4)
    SpecGx LLC
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    8801 Capital Boulevard, R...
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    Hwail Pharmaceutical Co., Ltd.
    2011-06-15
    20050831-32-C-126-07(2)
    SpecGx LLC
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    Agerson Bio Co., Ltd.
    2022-06-10
    20050831-32-C-126-07(5)
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    Wonpoong Pharmaceutical Co., Ltd.
    2011-05-16
    20050831-32-C-126-07(1)
    SpecGx LLC
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    8801 Capital Boulevard, R...
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