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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Dottikon Exclusive Synthesis Ag to the Review Authority in Korea.

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    01 Acalabrutinib (1)

    02 Acalabrutinib maleate monohydrate (1)

    03 Isosorbide dinitrate (2)

    04 Olaparib (1)

    05 Osimertinib mesylate (1)

    06 Zolmitriptan (1)

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    01 AstraZeneca Korea Co., Ltd. (5)

    02 Kolon Pharmaceutical Co., Ltd. (1)

    03 Korea Unifarm Co., Ltd. (1)

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    01 Dottikon Exclusive Synthesis AG (7)

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    01 Switzerland (7)

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    Acalabrutinib

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    AstraZeneca Korea Co., Ltd.
    2021-02-05
    Wed248-15-ND
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17, 5605 ...
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    Acalabrutinib maleate monohydrate

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    AstraZeneca Korea Co., Ltd.
    2023-02-25
    Wed248-19-ND
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17, 5605 ...
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    Isosorbide dinitrate

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    Korea Unifarm Co., Ltd.
    2020-08-28
    20200828-209-J-668
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17 5605 D...
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    Isosorbide dinitrate

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    Kolon Pharmaceutical Co., Ltd.
    2021-03-25
    20200828-209-J-668(1)
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17 CH-560...
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    Olaparib

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    AstraZeneca Korea Co., Ltd.
    2019-10-29
    Wed248-11-ND
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17 CH-560...
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    • FDA
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    Osimertinib mesylate

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    AstraZeneca Korea Co., Ltd.
    2022-04-27
    Wed248-18-ND
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17 CH-560...
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    • FDA
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    Zolmitriptan

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    AstraZeneca Korea Co., Ltd.
    2021-12-08
    20211208-209-J-1173
    Dottikon Exclusive Synthe...
    Switzerland
    Hembrunnstrasse 17, 5605 ...
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