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

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01 Bericiguat (1)

02 Ciprofloxacin (2)

03 Ciprofloxacin hydrochloride hydrate (1)

04 Cyproterone Acetate (1)

05 Dieno Guest (1)

06 EOB-DTPA (1)

07 Estradiol hemihydrate (1)

08 Estradiol hemihydrate (micronized) (1)

09 Estradiol valerate (3)

10 Gadobutrol (1)

11 Iopromide (1)

12 Moxifloxacin Hydrochloride (2)

13 Regorafenib hydrate (1)

14 Rivaroxaban (1)

15 Sorafenib tosylate (1)

16 acaboz (1)

17 drospirenone (1)

18 estradiol (1)

19 finerenone (1)

20 methylprednisolone acetonate (1)

21 nifedipine (3)

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01 Bayer Korea Co., Ltd. (22)

02 Hyundai Pharmaceutical Co., Ltd. (2)

03 JTech Biogen (1)

04 Myungmoon Pharmaceutical Co., Ltd. (1)

05 Novartis Korea Co., Ltd. (1)

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01 Bayer AG (10)

02 Bayer AG "Bergkamen" (all processes except micronization)@Bayer AG "Berlin-Charlottenburg" (micronization) (2)

03 Bayer AG "Bergkamen" (pre-process other than micronization process)@Bayer AG "Berlin-Charlottenburg" (micronization process) (1)

04 Bayer AG "Bergkamen"@Bayer AG "Berlin-Charlottenburg" (1)

05 Bayer AG, "Bergkamen" (undifferentiated: Bayer AG, "Berlin-Charlottenburg") (1)

06 Bayer AG@Bayer AG (4)

07 Bayer AG@Bayer AG@Bayer AG (1)

08 Bayer AG@Bayer AG@Zhejiang Xianju Pharmaceutical Co., Ltd. (1)

09 Bayer AG@Dynamit Nobel GmbH Explosivstoff- und Systemtechnik (1)

10 Bayer AG@[Micronization process manufacturer] Bayer AG (1)

11 Bayer Hispania SL, La Felguera (1)

12 Bayer Pharma AG "Bergkamen" (all processes other than micronization process)@Bayer Pharma AG "Berlin-Charlottenburg" (micronization process) (1)

13 Bayer Pharma AG Bergkamen Facility (all processes other than micronization process) @Bayer Pharma AG Berlin-Charlottenburg Facility (micronization process) (1)

14 [Processes other than micronization (rivaroxaban manufacturing)] Bayer AG@[micronization manufacturing plant ①] Bayer AG@[micronization manufacturing plant ②] Bayer HealthCare Manufacturing Srl (1)

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01 Germany (26)

02 Spain (1)

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Bayer Korea Co., Ltd.
2013-01-04
20130104-153-I-168-01
Bayer AG
Germany
Friedrich-Ebert-Str. 217-...
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Bayer Korea Co., Ltd.
2021-11-30
Wed212-8-ND
Bayer AG@Bayer AG
Germany
Friedrich-Ebert-Str. 217-...
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Bayer Korea Co., Ltd.
2011-05-16
20110516-85-D-92-17
Bayer AG
Germany
Friedrich-Ebert-Str. 217-...
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Bayer Korea Co., Ltd.
2011-05-16
20110516-85-D-93-16
Bayer AG
Germany
51368 Leverkusen
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Bayer Korea Co., Ltd.
2007-12-31
20071228-85-D-49-07
Bayer AG
Germany
Friedrich-elbert-Str. 217...
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Bayer Korea Co., Ltd.
2021-08-10
20210810-209-J-1087
Bayer AG@Bayer AG
Germany
Ernst-Schering-Straβe 14...
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Bayer Korea Co., Ltd.
2011-05-16
Wed2420-4-ND
Bayer AG, "Bergkamen" (un...
Germany
Bergkamen Plant: Ernst-Sc...
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Bayer Korea Co., Ltd.
2006-03-02
309-2-ND
Bayer AG@[Micronization p...
Germany
Ernst-Schering-Straße 14...
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Bayer Korea Co., Ltd.
2006-05-11
309-3-ND
Bayer AG
Germany
Ernst-Schering-Straße 14...
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Myungmoon Pharmaceutical Co., Ltd.
2014-06-19
20121228-181-I-166-03(1)
Bayer AG "Bergkamen" (all...
Germany
Ernst-Schering-Straße 14...
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