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List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Kolon Life Science, Inc to the Review Authority in Japan (PMDA). Original Data : PMDA

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01 Argatroban (1)

02 Argatroban (C) (1)

03 Candesartan Cilexetil (1)

04 Day stations Loxoprofensodium (production only) (1)

05 Donepezil hydrochloride (C) (1)

06 Famciclovir (1)

07 Felbinac (C) (1)

08 Felbinac (CP) (1)

09 Felbinac (N) (1)

10 Fexofenadine Hydrochloride (C) (1)

11 Fexofenadine hydrochloride (1)

12 Flurbiprofen (C) (1)

13 Flurbiprofen (N) (1)

14 Gefitinib (1)

15 Japanese Pharmacopoeia felbinac (1)

16 Japanese Pharmacopoeia flurbiprofen (1)

17 Japanese Pharmacopoeia ketoprofen (1)

18 LOXOPROFEN SODIUM HYDRATE (1)

19 Levofloxacin (1)

20 Levofloxacin (N) (1)

21 Losartan potassium (1)

22 Loxoprofen A Sid (1)

23 Loxoprofen Sodium (N) (1)

24 Loxoprofen Sodium Hydrate (2)

25 Loxoprofen Sodium Hydrate (C) (1)

26 Loxoprofen sodium (KOLON Chungju) (1)

27 Mirtazapine (1)

28 Nadifloxacin (1)

29 Nadifloxacin (C) (1)

30 Olmesartan medoxomil (1)

31 Olopatadine hydrochloride (1)

32 Outsiders regulations Soviet Falcon (production only) (1)

33 Pitavastatin calcium (1)

34 Pitavastatin calcium (C) (1)

35 Pitavastatin calcium (Y) (1)

36 Rosuvastatin calcium (1)

37 Seo Falcon (N) (1)

38 Seo Falcon (R) (1)

39 Sumatriptan succinate (1)

40 Voglibose (1)

41 Voglibose (C) (1)

42 Voglibose (N) (1)

43 Zaltoprofen (1)

44 Zaltoprofen (N) (1)

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01 KOLON LIFE SCIENCE, INC. (45)

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01 South Korea (45)

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KOLON LIFE SCIENCE, INC.
2019-09-17
2006-01-31
218MF10153
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2021-05-10
2021-05-10
303MF10076
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2012-11-28
2012-11-28
224MF10225
13, KOLON-RO, GWACHEON-SI...
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KOLON LIFE SCIENCE, INC.
2009-05-27
2006-01-31
218MF10158
13, KOLON-RO, GWACHEON-SI...
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KOLON LIFE SCIENCE, INC.
2021-09-17
2021-09-17
303MF10149
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2017-05-10
2016-06-21
228MF10115
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2021-10-07
2021-10-07
303MF10157
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2017-07-14
2017-07-14
229MF10124
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2010-08-10
2010-08-10
222MF10215
110, MAGOKDONG-RO, GANGSE...
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KOLON LIFE SCIENCE, INC.
2011-06-15
2011-06-15
223MF10079
110, MAGOKDONG-RO, GANGSE...
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