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

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01 BENICAR HCTR (OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE) TABLETS (1)

02 BENICAR(TM) TABLETS 5 MG, 20 MG AND 40 MG (1)

03 BULK CS-045 ORAL HYPOGLYCEMIC (1)

04 BULK FORM OF NIMUSTINE HCL (NIDRAN) (1)

05 CARPERITIDE DRUG SUBSTANCE (1)

06 CEFMETAZOLE (FREE ACID) (1)

07 CEFMETAZOLE SODIUM INJECTION(VIALS) (1)

08 CETRAXATE HCl CAPSULES (1)

09 CETRAXATE HYDROCHLORIDE (1)

10 CS-003 DRUG PRODUCT (1)

11 CS-003 DRUG SUBSTANCE (1)

12 CS-011 DRUG PRODUCT (1)

13 CS-023 DRUG SUBSTANCE (1)

14 CS-088 DRUG SUBSTANCE (1)

15 CS-505 DRUG PRODUCT (1)

16 CS-505 DRUG SUBSTANCE (1)

17 CS-514BULK SUBSTANCE PROCESSED TANASHI(TOKYO)& SHINAGAWA(TOKYO)PLANTS (1)

18 CS-615 DRUG PRODUCT (1)

19 CS-622 DRUG SUBSTANCE (1)

20 CS-622 FINISHED DOSAGE FORM (1)

21 CS-758 DRUG PRODUCT (1)

22 CS-758 DRUG SUBSTANCE (1)

23 CS-780 DRUG PRODUCT (1)

24 CS-780 DRUG SUBSTANCE (1)

25 CS-807 CEFPODOXIME PROXETIL DRUG SUBSTANCE (1)

26 CS-807 TABLETS (1)

27 CS-834 DRUG PRODUCT (1)

28 CS-834 DRUG SUBSTANCE (1)

29 CS-866 DRUG PRODUCT (1)

30 CS-866 DRUG SUBSTANCE (1)

31 CS-866(5 10 20 & 40MG) TABLETS (1)

32 CS-866-HYDROCHLOROTHIAZIDE TABLETS (CS-866HCTZ) (1)

33 CS-917 DRUG PRODUCT (1)

34 CS-917 DRUG SUBSTANCE (1)

35 DATICHI PHARMACEUTICAL CO LTD DU-6859A (1)

36 DE-310 DRUG SUBSTANCE (1)

37 DF-4639 INTERMEDIATE (1)

38 DK-507K DRUG SUBSTANCE (1)

39 DL 8280 MEFOXACIN ACTIVE & PLACEBO TABS (1)

40 DL-8280 CAPSULES (1)

41 DL-8280, BULK FORM (1)

42 DR-3355 BULK SUBSTANCE (1)

43 DS-1594B DRUG PRODUCT (1)

44 DS-1594B DRUG SUBSTANCE (1)

45 DS-4152 DRUG SUBSTANCE (1)

46 DT-5621 DRUG SUBSTANCE (1)

47 DU-176B DRUG SUBSTANCE (1)

48 DW-908E DRUG SUBSTANCE (1)

49 DX-619 DRUG SUBSTANCE (1)

50 DX-8951F DRUG SUBSTANCE (2)

51 DX-9065A (1)

52 DZ-697B DRUG SUBSTANCE (1)

53 EPIRIZOLE (MEBRON) (1)

54 FACILITIES AND OPERATING PROCEDURES IN HIRATSUKA-SHI, JAPAN (1)

55 L-PHENYLALANINE (1)

56 L-TRYPTOPHAN (1)

57 L-VALINE (1)

58 LEVODOPA AS PRODUCED IN THE HIRATSUKA PLANT (1)

59 LEVOFLOXACIN DRUG SUBSTANCE (1)

60 MAAA-1162A (1)

61 MAAA-1162A (COMMERCIAL) (1)

62 MALOTILATE 200 MG TABLETS (1)

63 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDOGAWA-KU, TOKYO, JAPAN. (2)

64 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SHIZUOKA JAPAN. (1)

65 METHIONINE-ENKEPHALIN (1)

66 METHIONINE-ENKEPHALIN AS PRODUCED IN THE FUNABORI FACTORY (TOKYO) (1)

67 MIX-RR (1)

68 MUCOPOLYSACCHARIDE POLYSULFATE DRUG SUBSTANCE (1)

69 NIMUSTINE HCL (NIDRAN) IN VIALS (1)

70 OFLOXACIN BULK PRODUCT (1)

71 OLMESARTAN MEDOXOMIL DRUG SUBSTANCE (1)

72 PANTETHINE BULK SUBSTANCE (1)

73 PANTOSIN 200 MG TABLETS (1)

74 PARENTERAL FORMULATION FACILITY IN OSAKA, JAPAN. (1)

75 POLYSULFATED GLYCOSAMINOGLYCAN (PSGAG) (1)

76 PRAVASTATIN SODIUM DRUG SUBSTANCE (1)

77 PRODUCTION TECHNOLOGY RESEARCH LABS., EDOGAWA-KU, TOKYO, JAPAN (1)

78 SUN A0026 DRUG SUBSTANCE (2)

79 SUN N 8075 DRUG SUBSTANCE (1)

80 SUN N4057 DRUG SUBSTANCE (1)

81 SUN11031 (HUMAN GHRELIN) DRUG SUBSTANCE (1)

82 SUN13834 DRUG SUBSTANCE (1)

83 SUN13837 DRUG SUBSTANCE (1)

84 TRANEXAMIC ACID (1)

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01 ASUBIO PHARMA CO LTD (3)

02 DAIICHI ASUBIO PHARMA CO LTD (2)

03 DAIICHI PHARMACEUTICAL CO LTD (15)

04 DAIICHI PURE CHEMICALS CO LTD (6)

05 DAIICHI PURE CHEMICALS CO LTD (JAPAN) (1)

06 DAIICHI SANKYO ALTKIRCH SARL (1)

07 DAIICHI SANKYO ALTKIRCH SAS (1)

08 DAIICHI SANKYO CHEMICAL PHARMA CO LTD (1)

09 DAIICHI SANKYO CO LTD (32)

10 DAIICHI SANKYO EUROPE GMBH (2)

11 DAIICHI SANKYO PROPHARMA CO LTD (2)

12 SANKYO CO LTD (21)

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01 Japan (87)

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01 Active (7)

02 Inactive (80)

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01 Blank (87)

URL Supplier Web Content
DAIICHI SANKYO CO LTD
Inactive
19629
N/A
2006-07-25
II
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DAIICHI SANKYO CO LTD
Inactive
17685
N/A
2004-09-14
II
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SANKYO CO LTD
Inactive
5461
N/A
1984-07-20
II
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ASUBIO PHARMA CO LTD
Inactive
14238
N/A
1999-06-28
II
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SANKYO CO LTD
Inactive
9887
N/A
1982-09-03
II
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SANKYO CO LTD
Inactive
5952
N/A
1985-08-14
II
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DAIICHI SANKYO CO LTD
Inactive
4448
N/A
1982-02-05
II
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DAIICHI SANKYO CO LTD
Inactive
4443
N/A
1982-02-05
II
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DAIICHI SANKYO CO LTD
Inactive
17229
N/A
2004-03-12
II
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DAIICHI SANKYO CO LTD
Inactive
17461
N/A
2004-06-14
II
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