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

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01 Bimatoprost (production only) (1)

02 Dinoprostone (1)

03 Dinopuron -EM (1)

04 Dried aluminum hydroxide gel fine "Kyowa Chemical" (1)

05 Gurishinaru (1)

06 Heavy Magnesium Oxide JP (1)

07 Istradefylline (production only) (1)

08 Japan Pharmaceutical Codex sugar-containing iron oxide (production only) (1)

09 Japanese Pharmacopoeia L- alanine (production only) (1)

10 Japanese Pharmacopoeia L- arginine (production only) (1)

11 Japanese Pharmacopoeia L- arginine hydrochloride (production only) (1)

12 Japanese Pharmacopoeia L- aspartic acid (production only) (1)

13 Japanese Pharmacopoeia L- glutamine (production only) (1)

14 Japanese Pharmacopoeia L- histidine (production only) (1)

15 Japanese Pharmacopoeia L- histidine hydrochloride hydrate (production only) (1)

16 Japanese Pharmacopoeia L- isoleucine (production only) (1)

17 Japanese Pharmacopoeia L- leucine (production only) (1)

18 Japanese Pharmacopoeia L- lysine acetate (production only) (1)

19 Japanese Pharmacopoeia L- lysine hydrochloride (production only) (1)

20 Japanese Pharmacopoeia L- phenylalanine (production only) (1)

21 Japanese Pharmacopoeia L- proline (production only) (2)

22 Japanese Pharmacopoeia L- serine (production only) (2)

23 Japanese Pharmacopoeia L- threonine (production only) (2)

24 Japanese Pharmacopoeia L- tryptophan (production only) (1)

25 Japanese Pharmacopoeia L- valine (production only) (1)

26 Japanese Pharmacopoeia Magnesium Oxide (for manufacturing only) (2)

27 Japanese Pharmacopoeia Pirushikainido hydrochloride hydrate (production only) (1)

28 Japanese Pharmacopoeia alprostadil alpha dexfenfluramine (production only) (1)

29 Japanese Pharmacopoeia benidipine hydrochloride (production only) (1)

30 Japanese Pharmacopoeia calcium hydrogen phosphate hydrate (manufactured only) (1)

31 Japanese Pharmacopoeia calcium pantothenate (production only) (1)

32 Japanese Pharmacopoeia cetraxate hydrochloride (production only) (1)

33 Japanese Pharmacopoeia citicoline (production only) (1)

34 Japanese Pharmacopoeia dopamine hydrochloride (production only) (1)

35 Japanese Pharmacopoeia dried aluminum hydroxide gel (produced only) (4)

36 Japanese Pharmacopoeia flavin adenine dinucleotide sodium (production only) (2)

37 Japanese Pharmacopoeia magnesium carbonate (production only) (2)

38 Japanese Pharmacopoeia magnesium oxide (production only) (9)

39 Japanese Pharmacopoeia magnesium silicate (manufacturing only) (1)

40 Japanese Pharmacopoeia olopatadine hydrochloride (production only) (1)

41 Japanese Pharmacopoeia pravastatin sodium (production only) (1)

42 Japanese Pharmacopoeia procaine hydrochloride (production only) (1)

43 Japanese Pharmacopoeia riboflavin butyric acid ester (production only) (1)

44 Japanese Pharmacopoeia sodium valproate (production only) (1)

45 Japanese Pharmacopoeia synthetic aluminum silicate (manufacturing only) (2)

46 Japanese Pharmacopoeia tranexamic acid (production only) (1)

47 Japanese Pharmacopoeia valsartan (production only) (1)

48 Kumuraito (1)

49 Kyowa Suimagu (2)

50 Latanoprost (1)

51 Lubiprostone (for manufacturing only) (1)

52 Outsider regulations L- aspartic acid calcium (manufactured only) (1)

53 Outsider regulations adenosine triphosphate disodium (manufactured only) (2)

54 Oxy glutathione Kyowa (1)

55 Sanarumin (2)

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01 Kyowa Chemical Industry Co., Ltd. (29)

02 Kyowa Hakko Bio Co., Ltd. (28)

03 Kyowa Pharma Chemical Co., Ltd. (19)

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01 Japan (76)

URL Supplier Web Content
Kyowa Pharma Chemical Co....
2023-02-08
2012-04-13
224MF10081
530 Chokeiji, Takaoka, To...
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Kyowa Pharma Chemical Co....
2018-06-07
2018-06-07
230MF10070
530 Chokeiji, Takaoka, To...
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Kyowa Chemical Industry C...
2010-02-12
2005-11-01
217MF10837
305 Yashimanishimachi, Ta...
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Kyowa Chemical Industry C...
2009-11-30
2009-11-30
221MF10256
305 Yashimanishimachi, Ta...
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Kyowa Chemical Industry C...
2010-01-07
2010-01-07
222MF10009
305 Yashimanishimachi, Ta...
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Kyowa Pharma Chemical Co....
2017-02-08
2017-02-08
229MF10036
530 Chokeiji, Takaoka, To...
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Kyowa Pharma Chemical Co....
2009-04-08
2005-05-24
217MF10117
530 Chokeiji, Takaoka, To...
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Kyowa Pharma Chemical Co....
2006-11-24
2006-11-24
218MF10946
530 Chokeiji, Takaoka, To...
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Kyowa Pharma Chemical Co....
2013-11-14
2013-11-14
225MF10209
530 Chokeiji, Takaoka, To...
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Kyowa Chemical Industry C...
2009-04-08
2009-04-08
221MF10072
305 Yashimanishimachi, Ta...
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