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

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01 2-N-BUTYL-1H-IMIDAZOLE-4-CARBOXALDEHYDE (BFI) (1)

02 AMINO ACID MIXTURE (1)

03 AMINO ACID MIXTURE ABBC (1)

04 AMINO ACID MIXTURE ABBU (1)

05 AMINO ACID MIXTURE ABBX (1)

06 BENZYL S-1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLATE P-TOLUENESULFONIC ACID SALT (THIQ) (1)

07 DILTIAZEM HCL (1)

08 DILTIAZEM HYDROCHLORIDE (PROCESS C) (1)

09 DILTIAZEM MALATE (1)

10 DL - METHIONINE (1)

11 DL-CARNITINE HYDROCHLORIDE (1)

12 DL-PHENYLALANINE (1)

13 DL-THREONINE (1)

14 DL-TRYPTOPHAN (1)

15 DL-VALINE (1)

16 FACILS., PERSONNEL & GENERAL OPERATING PROCEDS-OF TOKYO,JAPAN PLANT (1)

17 FACILS.,PERSONNEL, & GENERAL OPERATING PROCEDS-OF OSAKA, JAPAN PLANT (1)

18 FACILS.,PERSONNEL, & GENERAL OPERATING PROCEDS-ONODA, JAPAN PLANT (1)

19 GLYCINE (AMINOACETIC ACID) (1)

20 HER.TIAZEPN (1)

21 L - TYROSINE ETHYLESTER MONOHYDROCHLORIDE (1)

22 L-ALANINE (2)

23 L-ARGININE BASE (1)

24 L-ARGININE MONOHYDROCHLORIDE (1)

25 L-ASPARAGINE MONOHYDRATE (1)

26 L-ASPARTIC ACID (1)

27 L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE (1)

28 L-GLUTAMIC ACID (1)

29 L-GLUTAMINE (1)

30 L-HISTIDINE BASE (1)

31 L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (1)

32 L-ISOLEUCINE (2)

33 L-LEUCINE (1)

34 L-LYSINE (1)

35 L-LYSINE ACETATE (1)

36 L-LYSINE MONOHYDROCHLORIDE (1)

37 L-PHENYLALANINE (1)

38 L-PROLINE (1)

39 L-SERINE (1)

40 L-THREONINE (2)

41 L-TRYPTOPHAN (1)

42 L-TYROSINE (1)

43 L-VALINE (1)

44 MCC-135 (BULK DRUG SUBSTANCE) (1)

45 MCC-257 (1)

46 MCC-555 (1)

47 MCI-196 DRUG SUBSTANCE (1)

48 MCI-9038 ARGATROBAN DRUG SUB. (1)

49 MKC-242 BULK DRUG SUBSTANCE (1)

50 MP-124 DRUG SUBSTANCE (1)

51 MP-513 DRUG SUBSTANCE (1)

52 MT-7716 DRUG SUBSTANCE (1)

53 PROTIRELIN (1)

54 SODIUM THIOPENTAL INJECTION (1)

55 TA-3090 (1)

56 TA-5707F (1)

57 THIOPENTAL SODIUM FOR INJECT (1)

58 URSODEOXYCHOLIC ACID (1)

59 Y-39983 DRUG SUBSTANCE (1)

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01 INTERNATIONAL CHEMICAL ENTITY JAPAN CO LTD (1)

02 MITSUBISHI TANABE PHARMA CORP (11)

03 NIPPON SYNTHETIC CHEMICAL INDUSTRIES (1)

04 TANABE SEIYAKU CO LTD (49)

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01 Japan (62)

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01 Active (1)

02 Inactive (61)

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01 Blank (62)

URL Supplier Web Content
NIPPON SYNTHETIC CHEM...
Inactive
13191
N/A
1998-09-18
II
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TANABE SEIYAKU CO LTD
Inactive
1990
N/A
1972-09-01
II
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TANABE SEIYAKU CO LTD
Inactive
4259
N/A
1981-07-24
II
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TANABE SEIYAKU CO LTD
Inactive
4194
N/A
1981-05-29
II
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TANABE SEIYAKU CO LTD
Inactive
4202
N/A
1981-05-29
II
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TANABE SEIYAKU CO LTD
Inactive
7593
N/A
1988-07-13
II
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TANABE SEIYAKU CO LTD
Inactive
3059
N/A
1977-11-11
II
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MITSUBISHI TANABE PHA...
Inactive
10381
N/A
1993-07-09
II
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TANABE SEIYAKU CO LTD
Inactive
11077
N/A
1994-09-09
II
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TANABE SEIYAKU CO LTD
Inactive
1832
N/A
1971-12-17
II
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