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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Sandoz B2b to the Review Authority in Korea.

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    01 Alpelisib (1)

    02 Amoxicillin Sodium (8)

    03 Ampicillin Sodium (2)

    04 Atorvastatin Calcium (2)

    05 Cefpodoxime Proxetil (2)

    06 Clarithromycin (1)

    07 Paclitaxel (1)

    08 Potassium clavulanate (14)

    09 Rosuvastatin Calcium (1)

    10 Simvastatin (1)

    11 amlodipine besylate (1)

    12 amoxicillin hydrate (6)

    13 everolimus (1)

    14 roxithromycin (1)

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    01 Boryeong Co., Ltd. (4)

    02 Chong Kun Dang Co., Ltd. (3)

    03 Geonil Pharmaceutical Co., Ltd. (1)

    04 GlaxoSmithKline Co., Ltd. (1)

    05 HK Innoen Co., Ltd. (1)

    06 IMCD Korea Co., Ltd. (1)

    07 Ilsung Pharmaceutical Co., Ltd. (1)

    08 Kolon Pharmaceutical Co., Ltd. (1)

    09 Leesung International Co., Ltd. (7)

    10 Novartis Korea Co., Ltd. (3)

    11 Penmix Co., Ltd. (6)

    12 Pfizer Pharmaceuticals Korea Co., Ltd. (1)

    13 Samjin Pharmaceutical Co., Ltd. (2)

    14 Samo Pharmaceutical Co., Ltd. (1)

    15 Samyang Holdings Co., Ltd. (1)

    16 Sandoz Korea Co., Ltd. (2)

    17 Shinpoong Pharmaceutical Co., Ltd. (4)

    18 Yuhan Corporation (2)

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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 Samyang Holdings Co., Ltd. (1)

    06 Sandoz GmbH (6)

    07 Sandoz GmbH@Sandoz Industrial Products S.A. (2)

    08 Sandoz Industrial Products S.A. (7)

    09 Sandoz Industrial Products SpA (1)

    10 Sandoz Industrial Products, S.A. (5)

    11 lek pharmaceuticals dd (1)

    12 lek pharmaceuticals dd, (2)

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    01 Austria (6)

    02 Italy (1)

    03 Slovenia (1)

    04 Slovenian (19)

    05 South Korea (1)

    06 Spain (12)

    07 Switzerland (2)

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    Alpelisib

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    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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    amoxicillin hydrate

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    Shinpoong Pharmaceutical Co., Ltd.
    2011-12-09
    20050831-30-A-59-01(5)
    Sandoz Industrial Product...
    Spain
    Ctra. Granollers - Carded...
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    amoxicillin hydrate

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    Penmix Co., Ltd.
    2011-11-11
    20050831-30-A-59-01(2)
    Sandoz Industrial Product...
    Spain
    Ctra.Granollers a Cardede...
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    amoxicillin hydrate

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    Yuhan Corporation
    2011-11-11
    20050831-30-A-59-01(1)
    Sandoz Industrial Product...
    Spain
    Ctra. Granollers a Carded...
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    amoxicillin hydrate

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    Chong Kun Dang Co., Ltd.
    2014-08-27
    20050831-30-A-59-01(8)
    Sandoz Industrial Product...
    Spain
    Ctra. Granollers a Carded...
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    amoxicillin hydrate

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    Geonil Pharmaceutical Co., Ltd.
    2005-08-31
    20050831-30-A-59-01
    Sandoz Industrial Product...
    Spain
    Ctra.Granollers a Cardede...
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    Boryeong Co., Ltd.
    2011-12-15
    20050831-30-A-59-01(6)
    Sandoz Industrial Product...
    Spain
    Ctra.Granollers a Cardede...
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    Amoxicillin Sodium

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    Shinpoong Pharmaceutical Co., Ltd.
    2012-09-04
    20101116-30-A-240-15(2)
    Sandoz GmbH
    Austria
    Biochemiestraße 10, A-62...
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    Penmix Co., Ltd.
    2013-05-02
    20101116-30-A-240-15(3)
    Sandoz GmbH
    Austria
    Biochemiestrasse 10, A-62...
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