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Suanfarma Suanfarma

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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Sumitomo Corporation to the U.S. FDA. Original Data : FDA Website

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01 2,4-THIAZOLE WING ACID HOSU ACTIVE ESTER (1)

02 2-BROMO-1-[(4-METHYL SULFONYL) PHENYL] ETHANONE (1)

03 AC - 485 MICROBEADS (1)

04 AT-4140 (1)

05 B-WING (1)

06 BICALUTAMIDE DRUG SUBSTANCE (1)

07 BMCB(INERMEDIATE) (1)

08 BNC-1021 (1)

09 CEFPIRAMIDE (1)

10 CITALOPRAM HYDROBROMIDE (1)

11 DIPIVEFRIN HYDROCHLORIDE (1)

12 DISOPYRAMIDE PHOSPHATE USP (1)

13 DROXIDOPA (1)

14 ENOXACIN SESQUIHYDRATE (1)

15 GLIPIZIDE (1)

16 HYDRALAZINE HYDROCHLORIDE (1)

17 KETOSULFONE (1)

18 LEVOBUNOLOL HYDROCHLORIDE (1)

19 MANUFACTURING SITE , FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HYOGO, JAPAN. (1)

20 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT BEFU WORKS IN HYOGO, JAPAN. (1)

21 MCC-555 (1)

22 MEROPENEM (1)

23 MEROPENEM BULK BLEND (1)

24 MEROPENEM/SODIUM CARBONATE (1)

25 MIRTAZAPINE (1)

26 ORBIFLOXACIN (1)

27 OXAPROZIN (1)

28 PAROXETINE HYDROCHLORIDE ANHYDRATE (1)

29 PBL (A STARTING MATERIAL FOR MANUFACTURING DRUG SUBSTANCES) (2)

30 POTASSIUM OTASTAT (1)

31 PRAZOSIN HYDROCHLORIDE (1)

32 R BACLOFEN (1)

33 RANIRESTAT (AS-3201) (1)

34 SB-210272 (INTERMEDIATE) (1)

35 SB210272 (1)

36 SC-26480 (INTERMEDIATE) (1)

37 SM-13496 (1)

38 SM-5887 (AMRUBICIN HYDROCHLORIDE) (1)

39 SM-8668 (1)

40 SMP-028 (1)

41 SMP-114 (1)

42 SMP-601 DRUG SUBSTANCE (1)

43 SMP-797 DRUG SUBSTANCE (1)

44 SMP-986 (1)

45 SNK-860 (1)

46 SUMITHRIN (1)

47 TERAZOSIN HYDROCHLORIDE (1)

48 TIMOLOL MALEATE (1)

49 ZONISAMIDE DRUG SUBSTANCE (1)

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01 DAINIPPON PHARMACEUTICAL CO LTD (2)

02 DAINIPPON SUMITOMO PHARMA CO LTD (5)

03 DS PHARMA ANIMAL HEALTH CO LTD (1)

04 SUMITOMO CHEMICAL CO LTD (28)

05 SUMITOMO DAINIPPON PHARMA CO LTD (6)

06 SUMITOMO PHARMA CO LTD (2)

07 SUMITOMO SEIKA CHEMICALS CO LTD (6)

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01 Japan (50)

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01 Active (7)

02 Inactive (43)

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01 Complete (1)

02 Blank (49)

URL Supplier Web Content
SUMITOMO SEIKA CHEMIC...
Active
12645
N/A
1997-09-08
II
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DAINIPPON PHARMACEUTI...
Inactive
8375
N/A
1990-01-16
II
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SUMITOMO CHEMICAL CO ...
Inactive
19311
N/A
2006-03-31
II
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SUMITOMO CHEMICAL CO ...
Inactive
6940
N/A
1987-04-23
II
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SUMITOMO CHEMICAL CO ...
Inactive
15836
N/A
2002-01-31
II
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SUMITOMO CHEMICAL CO ...
Inactive
9552
N/A
1992-02-20
II
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SUMITOMO CHEMICAL CO ...
Active
4687
N/A
1982-10-14
II
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SUMITOMO DAINIPPON PH...
Inactive
20556
N/A
2007-05-23
II
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DAINIPPON PHARMACEUTI...
Inactive
7252
N/A
1987-12-09
II
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SUMITOMO CHEMICAL CO ...
Inactive
8805
N/A
1990-10-31
II
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