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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)

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