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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Kyowa Hakko Bio Co Ltd to the U.S. FDA. Original Data : FDA Website

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01 ACEGLUTAMIDE ALUMINUM (1)

02 ACEGLUTAMIDE ALUMINUM GRANULES (KW-110) (1)

03 ADENOSINE (1)

04 ADENOSINE TRIPHOSPHATE DISODIUM (1)

05 AICA-RIBOSIDE (1)

06 ALPHA-MERCAPTOPROPIONYLGLYCINE (1)

07 AMINO ACID BLEND "KYOWA",TYPE TR-1 (1)

08 AMINO ACID MIXTURES (1)

09 AMINO ACIDS (3)

10 AMINO ACIDS--GENERAL INFO ON BULK DRUG SUBSTANCES (1)

11 AMINOETHYLSULFONIC ACID (TAURINE) (1)

12 BIMATOPROST DRUG SUBSTANCE (1)

13 BUCILLAMINE BULK SUBSTANCE (1)

14 CI-920 (FOSTRIECIN) BULK FORM (1)

15 CITICOLINE MONOSODIUM SALT (1)

16 D-SERINE (BULK SUBSTANCE) (1)

17 DACARBAZINE (1)

18 DACARBAZINE ( (1)

19 DINOPROSTONE DRUG SUBSTANCE (1)

20 DX-52-1 BULK MATERIAL (1)

21 FACILITIES & CONTROLS (UBE PLANT IN JAPAN) (1)

22 FACILITIES AND PROCEDURES IN SHIZUOKA PREFECTURE, JAPAN (1)

23 GP531T DRUG SUBSTANCE (1)

24 KW-2189 DRUG SUBSTANCE (1)

25 L-ALANINE (1)

26 L-ARGININE, L-ARGININE MONOHYDROCHLORIDE (1)

27 L-ASPARAGINASE (1)

28 L-CYSTINE & DERIVATIVE L-CYSTINE HCL & N-ACETYL-L-CYSTEIN (1)

29 L-CYSTINE AND L-CYSTINE MONOHYDROCHLORIDE (1)

30 L-DOPAMINE HYDROCHLORIDE (3-HYDROXYTYRAMINE HYDROCHLORIDE ) (1)

31 L-GLUTATHIONE REDUCED (ORAL GRADE) (1)

32 L-ISOLEUCINE (1)

33 L-LEUCINE (1)

34 L-MALIC ACID (1)

35 L-TRYPTOPHAN, L-TYROSINE, L-ASPARTIC ACID (L-PROLINE, L-GLUTAMIC) (1)

36 L-VALINE, L-THREONINE, L-GLUTAMINE (1)

37 LATANOPROST (1)

38 MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE REDUCED (1)

39 MANUFACTURING AND QUALITY INFORMATION ON L-GLUTATHIONE OXIDIZED (1)

40 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ASHIKAGA-SHI, JAPAN. (1)

41 MINOCYCLINE HYDOCHLORIDE, SAKAI PLANT, OSAKA PREFECTURE JAPAN (1)

42 MINOCYCLINE HYDROCHLORIDE (1)

43 MISOPROSTOL DRUG SUBSTANCE (1)

44 MISOPROSTOL HPMC DISPERSION (1)

45 MITOMYCIN (1)

46 OLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE (1)

47 PEGYLATED GRANULOCYTE COLONY-STIMULATING FACTOR MUTEIN BULK SUBSTANCE (1)

48 PRAVASTATIN SODIUM (1)

49 SODIUM HYALURONATE (2)

50 SODIUM SULFADIMETHOXINE (1)

51 SULFADIMETHOXINE (1)

52 TRANEXAMIC ACID DRUG SUBSTANCE (1)

53 UBIDECARENONE BULK (1)

54 URACIL (1)

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01 DAIICHI FINE CHEMICAL CO LTD (4)

02 KYOWA HAKKO BIO CO LTD (6)

03 KYOWA HAKKO KOGYO CO LTD (33)

04 KYOWA HAKKO USA INC (8)

05 KYOWA PHARMA CHEMICAL CO LTD (6)

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01 Japan (57)

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01 Active (8)

02 Inactive (49)

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01 Complete (2)

02 Blank (55)

URL Supplier Web Content
KYOWA HAKKO KOGYO CO ...
Inactive
5337
N/A
1984-04-11
II
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KYOWA HAKKO KOGYO CO ...
Inactive
5314
N/A
1984-04-11
II
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KYOWA HAKKO KOGYO CO ...
Inactive
8828
N/A
1990-11-20
II
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KYOWA HAKKO KOGYO CO ...
Inactive
9569
N/A
1992-03-02
II
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KYOWA HAKKO KOGYO CO ...
Inactive
8405
N/A
1990-01-25
II
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KYOWA HAKKO KOGYO CO ...
Inactive
6809
N/A
1987-02-05
II
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KYOWA HAKKO KOGYO CO ...
Inactive
3223
N/A
1978-06-16
II
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KYOWA HAKKO BIO CO LT...
Inactive
3407
N/A
1979-01-09
II
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KYOWA HAKKO KOGYO CO ...
Inactive
2631
N/A
1976-03-18
II
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KYOWA HAKKO BIO CO LT...
Active
3131
N/A
1978-02-27
II
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