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List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Kyongbo Pharmaceutical Co., Ltd to the Review Authority in Japan (PMDA). Original Data : PMDA

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01 Amlodipine besylate (production only) (1)

02 Atorvastatin Calcium Hydrate (KBP) (1)

03 Atorvastatin calcium hydrate (production only) (1)

04 Azilsartan (1)

05 Blonanserin (1)

06 Cefixime hydrate (1)

07 Cefmethazole sodium (1)

08 Cefoperazone sodium (1)

09 Cefotiam hydrochloride (1)

10 Cefotiam hydrochloride (production only) (1)

11 Ceftriaxone sodium hydrate (2)

12 Clarithromycin (1)

13 Clarithromycin (production only) (1)

14 Clopidogrel sulfate (1)

15 Day stations mosapride acid hydrate (production only) (1)

16 Diquafosol Sodium (1)

17 Doxifluridine (1)

18 Entacapone (1)

19 Entacapone (1)

20 Entecavir hydrate (1)

21 Imatinib mesylate (1)

22 Imidapril hydrochloride (1)

23 Japanese Pharmacopoeia cefmethazole sodium (sterile) (1)

24 Japanese Pharmacopoeia sulbactam sodium (production only) (1)

25 Luliconazole (1)

26 Montelukast Sodium (1)

27 Montelukast sodium (1)

28 Montelukast sodium (manufacturing only) (1)

29 Nateglinide (1)

30 Olmesartan medoxomil (1)

31 Oteracil potassium (1)

32 Palonosetron Hydrochloride (1)

33 Pitavastatin calcium (production only) (1)

34 Pitavastatin calcium hydrate (1)

35 Pranlukast hydrate (for manufacturing only) (1)

36 Raloxifene hydrochloride hydrate (1)

37 Rosuvastatin calcium (1)

38 Sefurokisajin hydrate (1)

39 Simvastatin (1)

40 Sulbactam sodium (production only) (1)

41 Telmisartan (1)

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01 Kyongbo Pharmaceutical Co. , Ltd. (41)

02 Kyongbo Pharmaceutical Co. ,Ltd (1)

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01 South Korea (41)

02 Blank (1)

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Kyongbo Pharmaceutical Co...
2013-06-19
2013-06-19
225MF10124
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2022-01-20
2022-01-20
304MF10015
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2013-04-05
2010-07-14
222MF10201
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2022-01-20
2019-12-25
301MF10112
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2017-12-01
2017-12-01
229MF10212
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2012-04-25
2012-04-25
224MF10092
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2021-10-21
2021-10-21
303MF10160
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2007-04-27
2005-09-14
217MF10577
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2017-02-08
2017-02-08
229MF10029
174, Sirok-ro, Asan-si, C...
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Kyongbo Pharmaceutical Co...
2007-03-14
2007-03-14
219MF10078
174, Sirok-ro, Asan-si, C...
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