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List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Osaka Synthetic Chemical Laboratories to the Review Authority in Japan (PMDA). Original Data : PMDA

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01 Blonanserin production dedicated (1)

02 Bromperidol For manufacturing only (1)

03 Cilnidipine production dedicated (1)

04 Clopidogrel salt production dedicated (1)

05 Deferasirox manufacturing only (1)

06 Japan Pharmaceutical Codex tramazoline hydrochloride salt production dedicated (1)

07 Japanese Pharmacopoeia Etilefrine Hydrochloride Manufacturing Dedicated (1)

08 Japanese Pharmacopoeia Sivelestat sodium hydrate production-only (1)

09 Japanese Pharmacopoeia Tosufloxacin Tosilate Hydrate Production Only (1)

10 Japanese Pharmacopoeia alprazolam production dedicated (1)

11 Japanese Pharmacopoeia bepotastine besilate production dedicated (1)

12 Japanese Pharmacopoeia bromide Chimepijiumu production dedicated (1)

13 Japanese Pharmacopoeia fexofenadine hydrochloride salt production dedicated (2)

14 Japanese Pharmacopoeia mosapride acid hydrate production-only (1)

15 Japanese Pharmacopoeia tartaric acid ifenprodil production dedicated (1)

16 Japanese Pharmacopoeia toss ciprofloxacin tosylate salt hydrate production-only (2)

17 Minodronic acid hydrate production-only (1)

18 Nalfurafine Hydrochloride For Manufacturing (1)

19 Nalfurafine hydrochloride salt production dedicated (1)

20 OSC-0617 (1)

21 Only the Japanese Pharmacopoeia Lafutidine production (1)

22 Only the Japanese Pharmacopoeia estazolam production (1)

23 Only the Japanese Pharmacopoeia ifenprodil tartrate salt production (1)

24 Only the Japanese Pharmacopoeia imidapril hydrochloride salt production (1)

25 Only the Japanese Pharmacopoeia paroxetine hydrochloride hydrate production (1)

26 Only the Japanese Pharmacopoeia pranlukast hydrate production (1)

27 Only the Japanese Pharmacopoeia taltirelin hydrate production (1)

28 Only the Japanese Pharmacopoeia teprenone production (1)

29 Only the Japanese Pharmacopoeia valacyclovir hydrochloride salt production (1)

30 Proxy Villingen (1)

31 Sertraline hydrochloride salt production dedicated (1)

32 Solifenacin succinate production only (1)

33 Stand spiron citrate production dedicated (1)

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01 Osaka Synthetic Organic Chemistry Institute Co., Ltd. (35)

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01 Japan (35)

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Osaka Synthetic Organic C...
2018-02-26
2018-02-26
230MF10035
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2023-04-25
2023-04-25
305MF10052
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2021-05-10
2013-01-18
225MF10006
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2014-11-17
2014-02-05
226MF10032
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2021-05-17
2019-01-11
231MF10012
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2008-09-29
2008-09-29
220MF10207
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2009-07-30
2005-08-10
217MF10394
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2020-07-06
2017-01-25
229MF10016
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2006-08-11
2006-08-11
218MF10686
1-1-2 Nishinomiyahama, Ni...
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Osaka Synthetic Organic C...
2023-06-14
2023-01-18
305MF10005
1-1-2 Nishinomiyahama, Ni...
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