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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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    Alpelisib

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    Novartis Korea Co., Ltd.
    2021-05-12
    Wed196-21-ND
    Lek Pharmaceuticals d.d.
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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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    Shinpoong Pharmaceutical Co., Ltd.
    2011-12-09
    20050831-30-A-59-01(5)
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    Ctra. Granollers - Carded...
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    Penmix Co., Ltd.
    2011-11-11
    20050831-30-A-59-01(2)
    Sandoz Industrial Product...
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    Ctra.Granollers a Cardede...
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    Yuhan Corporation
    2011-11-11
    20050831-30-A-59-01(1)
    Sandoz Industrial Product...
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    Ctra. Granollers a Carded...
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    Chong Kun Dang Co., Ltd.
    2014-08-27
    20050831-30-A-59-01(8)
    Sandoz Industrial Product...
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    Ctra. Granollers a Carded...
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    Geonil Pharmaceutical Co., Ltd.
    2005-08-31
    20050831-30-A-59-01
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    amoxicillin hydrate

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    Boryeong Co., Ltd.
    2011-12-15
    20050831-30-A-59-01(6)
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    Amoxicillin Sodium

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    Chong Kun Dang Co., Ltd.
    2011-12-09
    20110916-30-A-249-17(2)
    Sandoz Industrial Product...
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    c/Gorg del Moli d'En Puig...
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    Penmix Co., Ltd.
    2011-09-16
    20110916-30-A-249-17
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    Amoxicillin Sodium

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    GlaxoSmithKline Co., Ltd.
    2010-11-16
    20101116-30-A-240-15
    Sandoz GmbH
    Austria
    Biochemiestrasse 10, A-62...
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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
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    Biochemiestraße 10, A-62...
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    Amoxicillin Sodium

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    Ilsung Pharmaceutical Co., Ltd.
    2012-02-03
    20101116-30-A-240-15(1)
    Sandoz GmbH
    Austria
    Biochemiestrasse 10, A-62...
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    Amoxicillin Sodium

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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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    Amoxicillin Sodium

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    Shinpoong Pharmaceutical Co., Ltd.
    2012-01-13
    20110916-30-A-249-17(4)
    Sandoz Industrial Product...
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    c/Gorg del Moli d'En Puig...
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    Amoxicillin Sodium

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    Samjin Pharmaceutical Co., Ltd.
    2011-12-15
    20110916-30-A-249-17(3)
    Sandoz Industrial Product...
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    c/Gorg del Moli d'En Puig...
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    Ampicillin Sodium

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    Leesung International Co., Ltd.
    2021-11-05
    20200603-210-J-404(1)
    Sandoz GmbH@Sandoz Indust...
    Switzerland
    Biochemiestraβe 10 6250 ...
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    Ampicillin Sodium

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    Pfizer Pharmaceuticals Korea Co., Ltd.
    2020-06-03
    20200603-210-J-404
    Sandoz GmbH@Sandoz Indust...
    Switzerland
    Biochemiestraβe 10 6250 ...
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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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    Cefpodoxime Proxetil

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    HK Innoen Co., Ltd.
    2014-07-25
    20140611-25-A-300-07(1)
    Sandoz GmbH
    Austria
    Biochemiestraβe 10, 6250...
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    Cefpodoxime Proxetil

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    Leesung International Co., Ltd.
    2014-06-11
    20140611-25-A-300-07
    Sandoz GmbH
    Austria
    Biochemiestraβe 10, 6250...
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    Clarithromycin

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    Boryeong Co., Ltd.
    2005-08-31
    20050831-62-A-124-04
    Sandoz Industrial Product...
    Spain
    Ctra. Granollers Cardedeu...
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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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    Paclitaxel

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    Samyang Holdings Co., Ltd.
    2005-08-31
    20050831-68-A-133-03
    Samyang Holdings Co., Ltd...
    South Korea
    79 Sinildong-ro, Daedeok-...
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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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    Penmix Co., Ltd.
    2011-12-02
    20081031-113-F-9-04(1)
    lek pharmaceuticals dd,
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    Perzonali 47, SI-2391 Pre...
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    Penmix Co., Ltd.
    2011-12-02
    20081031-113-F-10-03(1)
    lek pharmaceuticals dd,
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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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    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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    Shinpoong Pharmaceutical Co., Ltd.
    2011-11-18
    20080930-113-F-8-02(3)
    Lek Pharmaceuticals d.d.
    Slovenian
    Trimlini 2D SI 9220 Lenda...
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    Potassium clavulanate

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    Penmix Co., Ltd.
    2011-11-18
    20080930-113-F-8-02(1)
    Lek Pharmaceuticals d.d.
    Slovenian
    Trimlini 2D SI 9220 Lenda...
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    Potassium clavulanate

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    Leesung International Co., Ltd.
    2008-10-31
    20081031-113-F-9-04
    Lek Pharmaceuticals d.d.
    Slovenian
    Perzonali 47, SI-2391 Pre...
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    Potassium clavulanate

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    Leesung International Co., Ltd.
    2008-10-31
    20081031-113-F-10-03
    Lek Pharmaceuticals d.d.
    Slovenian
    Perzonali 47, SI-2391 Pre...
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    Potassium clavulanate

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    Leesung International Co., Ltd.
    2008-09-30
    20080930-113-F-8-02
    Lek Pharmaceuticals d.d.
    Slovenian
    Trimlini 2D SI 9220 Lenda...
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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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    Potassium clavulanate

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    Chong Kun Dang Co., Ltd.
    2012-01-13
    20080930-113-F-8-02(5)
    Lek Pharmaceuticals d.d.
    Slovenian
    Trimlini 2D SI 9220 Lenda...
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    Potassium clavulanate

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    Samjin Pharmaceutical Co., Ltd.
    2011-12-15
    20080930-113-F-8-02(4)
    Lek Pharmaceuticals d.d.
    Slovenian
    Trimlini 2D SI 9220 Lenda...
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    Rosuvastatin Calcium

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    Sandoz Korea Co., Ltd.
    2021-04-06
    20210406-209-J-687
    Lek Pharmaceuticals d.d.
    Slovenian
    Kolodvorska cesta 27,1234...
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    roxithromycin

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    Kolon Pharmaceutical Co., Ltd.
    2005-08-31
    20050831-9-A-1-01
    Sandoz Industrial Product...
    Spain
    Ctra.Granollers a Cardede...
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    Simvastatin

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    Samo Pharmaceutical Co., Ltd.
    2009-03-31
    20090331-29-B-282-21
    Sandoz Industrial Product...
    Italy
    Corso Verona, 165 38068 R...
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