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

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01 -KETO ACID MIXTURE EE (1)

02 -KETO ACID SALTS OF L-AMINO ACIDS (1)

03 2'3'-DIDEOXYINOSINE (1)

04 5-HYDROXY-L-TRYPTOPHAN (1)

05 6-MERCAPTOPURINE (1)

06 A-4166 (1)

07 A-84538.0 (RITONAVIR) (1)

08 ACYCLOVIR (1)

09 ADENOSINE (1)

10 AMINO ACID MIXTURE BAX-D (1)

11 AMINO ACID PRODUCTS (1)

12 AMINO ACIDS (1)

13 AMPHOTERICIN B (1)

14 AT-1015 A 5-HT2A ANTAGONIST (1)

15 BALSALAZIDE DISODIUM (2)

16 BOC CORE SUCCINATE A88820.605 (1)

17 CILOSTAZOL (1)

18 CIRAMADOL HYDROCHLORIDE (1)

19 CURDLAN SULFATE SODIUM INTRAVENOUS (1)

20 DESERPIDINE AS PRODUCED IN LOUVAIN-LA-NEUVE PILOT PLANT (1)

21 DIPYRIDAMOLE (1)

22 DIPYRIDAMOLE USP (1)

23 ETOPOSIDE (1)

24 GALANTAMINE HBR (1)

25 GALANTAMINE HYDROBROMIDE (1)

26 GLYCYL-L-GLUTAMINE HYDRATE (1)

27 INTRAVENOUS LENTINAN (1)

28 IRBESARTAN CRUDE (1)

29 L-ALANINE (2)

30 L-ALANYL-GLUTAMINE (1)

31 L-ARGININE (1)

32 L-ARGININE MONOHYDROCHLORIDE (2)

33 L-ASPARTIC ACID (1)

34 L-CYSTEINE HYDROCHLORIDE MONOHYDRATE (1)

35 L-GLUTAMIC ACID (1)

36 L-GLUTAMINE (1)

37 L-HISTIDINE (1)

38 L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE (1)

39 L-ISOLEUCINE (2)

40 L-LEUCINE (3)

41 L-LYSINE ACETATE (2)

42 L-LYSINE MONOHYDROCHLORIDE (2)

43 L-PHENYLALANINE (2)

44 L-PROLINE (1)

45 L-SERINE (1)

46 L-SERINE (PROCESS II) (1)

47 L-THREONINE (2)

48 L-TRYPTOPHAN (1)

49 L-TYROSINE (1)

50 L-VALINE (2)

51 LEVODOPA (2)

52 M-HES (1)

53 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN YOKKAICHI, MIE PREFECTURE, JAPAN (1)

54 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF CRYSTALLINE AMINO ACIDS IN RALEIGH, NORTH CAROLINA. (1)

55 METHOCARBAMOL USP (1)

56 MICONAZOLE NITRATE (1)

57 N-ACETYL-D-GLUCOSAMINE (1)

58 N-ACETYL-L-CYSTEINE (1)

59 NEFAZODONE II (1)

60 PANCURONIUM BROMIDE (1)

61 PENTAMIDINE ISETHIONATE (1)

62 PRAZOSIN HYDROCHLORIDE (1)

63 PROPANETRIOL TRINITRATE 10% WITH LACTOSE (1)

64 PROPRANOLOL HCL (1)

65 T-3811A15 (1)

66 TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK. (1)

67 VERAPAMIL HCL (1)

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01 AJINOMOTO CO INC (22)

02 AJINOMOTO DO BRASIL INDUSTRIA E COMERCIO DE ALIMENTOS LTDA (2)

03 AJINOMOTO HEALTH AND NUTRITION NORTH AMERICA INC (12)

04 AJINOMOTO NORTH AMERICA INC (1)

05 AJINOMOTO USA INC (3)

06 NIPPON PROTEIN CO INC (1)

07 NIPPON PROTEIN CO LTD (2)

08 NV AJINOMOTO OMNICHEM SA (1)

09 OMNICHEM NV (10)

10 OMNICHEM SA (6)

11 SA AJINOMOTO OMNICHEM NV (10)

12 SHANGHAI AJINOMOTO AMINO ACID CO LTD (8)

13 SHANGHAI ASIA PIONEER CO LTD (1)

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01 Belgium (16)

02 Japan (51)

03 U.S.A (12)

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01 Active (34)

02 Inactive (45)

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01 Complete (29)

02 Blank (50)

URL Supplier Web Content
AJINOMOTO CO INC
Inactive
7694
N/A
1988-09-30
II
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OMNICHEM SA
Inactive
5078
N/A
1983-09-12
II
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SA AJINOMOTO OMNICHEM...
Inactive
9359
N/A
1991-09-23
II
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AJINOMOTO CO INC
Inactive
11155
N/A
1994-10-24
II
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AJINOMOTO CO INC
Inactive
11677
N/A
1995-09-25
II
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OMNICHEM SA
Inactive
10124
N/A
1993-03-02
II
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AJINOMOTO CO INC
Inactive
17621
N/A
2004-08-16
II
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SA AJINOMOTO OMNICHEM...
Inactive
17467
N/A
2004-05-24
II
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AJINOMOTO CO INC
Active
1076
Complete
2018-08-14
2018-07-02
1967-08-15
II
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AJINOMOTO HEALTH AND ...
Active
4555
Complete
2018-08-14
2018-07-02
1982-03-17
II
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