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

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    01 Alpelisib (1)

    02 Atorvastatin Calcium (2)

    03 Potassium clavulanate (14)

    04 Rosuvastatin Calcium (1)

    05 amlodipine besylate (1)

    06 everolimus (1)

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    01 Boryeong Co., Ltd. (2)

    02 Chong Kun Dang Co., Ltd. (1)

    03 IMCD Korea Co., Ltd. (1)

    04 Leesung International Co., Ltd. (5)

    05 Novartis Korea Co., Ltd. (3)

    06 Penmix Co., Ltd. (3)

    07 Samjin Pharmaceutical Co., Ltd. (1)

    08 Sandoz Korea Co., Ltd. (2)

    09 Shinpoong Pharmaceutical Co., Ltd. (1)

    10 Yuhan Corporation (1)

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    01 Lek Pharmaceuticals d.d. (13)

    02 Lek Pharmaceuticals dd (all process) @[mixing process manufacturing plant 1] Novartis Pharma AG @[mixing process manufacturing plant 2] Novartis Pharma Stein AG (1)

    03 Lek Pharmaceuticlas d.d. (1)

    04 Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava (2)

    05 lek pharmaceuticals dd (1)

    06 lek pharmaceuticals dd, (2)

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    01 Slovenia (1)

    02 Slovenian (19)

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    Alpelisib

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    URL Supplier Web Content
    Novartis Korea Co., Ltd.
    2021-05-12
    Wed196-21-ND
    Lek Pharmaceuticals d.d.
    Slovenian
    Kolodvorska cesta 27,1234...
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    amlodipine besylate

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    Novartis Korea Co., Ltd.
    2010-11-30
    20101130-130-H-45-06
    Lek Pharmaceuticals d.d.
    Slovenian
    Kolodvorska cesta 27,1234...
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    Atorvastatin Calcium

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    IMCD Korea Co., Ltd.
    2011-11-11
    20101011-132-H-1-02(1)
    Lek Pharmaceuticals d.d.
    Slovenian
    Kolodvorska cesta 27, 123...
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    Atorvastatin Calcium

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    Sandoz Korea Co., Ltd.
    2010-10-11
    20101011-132-H-1-02
    Lek Pharmaceuticlas d.d.
    Slovenian
    Kolodvorska cesta 27, 123...
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    everolimus

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    Novartis Korea Co., Ltd.
    2016-09-19
    Wed196-14-ND
    Lek Pharmaceuticals dd (a...
    Slovenia
    Kolodvorska cesta 27, Men...
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    Potassium clavulanate

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    Boryeong Co., Ltd.
    2014-04-10
    20081031-113-F-10-03(3)
    Lek Pharmaceuticals d.d.
    Slovenian
    Perzonali 47, SI-2391 Pre...
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    Potassium clavulanate

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    Leesung International Co., Ltd.
    2022-04-25
    20220425-113-F-96-26
    Lek farmacevtska družba ...
    Slovenian
    Trimlini 2D, Lendava, 922...
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    Potassium clavulanate

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    Leesung International Co., Ltd.
    2022-04-25
    20220425-113-F-95-25
    Lek farmacevtska družba ...
    Slovenian
    Trimlini 2D, Lendava, 922...
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    Potassium clavulanate

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    Boryeong Co., Ltd.
    2015-09-09
    20081031-113-F-9-04(2)
    Lek Pharmaceuticals d.d.
    Slovenian
    Perzonali 47, SI-2391 Pre...
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    Potassium clavulanate

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    Yuhan Corporation
    2018-02-08
    20081031-113-F-10-03(4)
    lek pharmaceuticals dd
    Slovenian
    Perzonali 47, SI-2391 Pre...
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