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

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01 1-(MERCAPTOMETHYL) CYCLOPROPYLACETIC ACID (1)

02 2-BUTYL-3-H-IMIDAZOL-4-CARBALDEHYDE (IMALOC SB 202783) (1)

03 ACTIVE INGREDIENT = 84A ANTIBODY (1)

04 AURANOFIN (1)

05 BROENAC SODIUM SESQUIHYDRATE (1)

06 BULK PURIFIED HUMAN MONOCLONAL ANTIBODY (ANTI-IL8) (NSO CELLS, LONZA) TO IL-8 (1)

07 BULK PURIFIED HUMANIZED MONOCLONAL ANTIBODY (AN100226)(NSO CELLS, LONZA) TO ALPHA 4 INTEGRIN (1)

08 BULK PURIFIED HUMANIZED MONOCLONAL ANTIBODY (H5G1-1)(NSO CELLS. LONZA) TO C5 (1)

09 CARSONON L-23 (1)

10 CARSONON L-4 (1)

11 CDT PHOSPHATE (1)

12 CHLORHEXIDINE GLUCONATE, 20% SOLUTION, BP 73 & CHLORHEXIDINE DIACETATE (1)

13 CHLORHEXIDINE HCL B.P. 73 (1)

14 CHLORPROMAZINE HCL (1)

15 CHORHEXIDINE DIACETATE BP 73 (1)

16 CN 28091 LACTOL-LACTAM (1)

17 CN 343 (SAS) (1)

18 CN25225 (METEXAFIN GADOLINIUM) (1)

19 CRUDE SG-3249 (1)

20 D5AA (1)

21 DEBMEB (1)

22 DESMOPRESSIN ACETATE (1)

23 DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL) (1)

24 DEXTROMETHOPHAN HYDROBROMIDE (1)

25 DEXTROMETHORPHAN BASE (1)

26 DL-2-(DIFLUOROMETHYL) ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE (1)

27 EC-037 (1)

28 EC-125 DRUG SUBSTANCE (1)

29 EPROSARTAN (1)

30 EPROSARTAN MESYLATE (ROUTE F) (1)

31 EPROSARTAN MESYLATE (ROUTE F1) (1)

32 ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE) (1)

33 ETH06 (TRABECTEDIN INTERMEDIATE) (1)

34 ETODOLAC (1)

35 ETODOLAC INTERMEDIATES (1)

36 FACILITY AND OPERATING PROCEDURES IN VISP, SWITZERLAND (1)

37 FACILS & PERSONNEL (D FORMERLY HELD BY CYCLO CHEM DIV TRAVENOL INC) (1)

38 FLAVOXATE HYDROCHLORIDE (1)

39 FLUVOXAMINE MALEATE (SV-006) (1)

40 HOST CELL LINE NS0 (1)

41 HOST CELL LINES CHO-K1, CHOK1SV AND CHOK1SV GS-KO (1)

42 HP67.6 ANTIBODY (1)

43 HYDROXYAMPHETAMINE HYDROBROMIDE (1)

44 IMMOBILIZED MONOCLONAL ANTIBODY (NK2) TO INTERFERON (1)

45 KETOSULFONE (1)

46 KW-2401 (1)

47 L-CARNITINE (VIT. BT) (1)

48 L-CARNITINE DIR (1)

49 L-CARNITINE USP (1)

50 LEVOCARNITINE TARTATE (1)

51 MC-VAL-ALA-PBD (1)

52 NIACIN USP GRANULAR SPECIAL (1)

53 NIACIN USP SPECIAL (1)

54 NIACINAMIDE (1)

55 NIACINAMIDE FOR ORAL USE (1)

56 PHENOXYBENZAMINE HCL (1)

57 PROCHLORPERAZINE, PROCHLORPERAZINE EDISYLATE,PROCHLORPERAZINE MALEATE (1)

58 PROPYLHEXEDRINE (1)

59 SB 200473 (1)

60 SB 201999 (1)

61 SB 217063 AND SK&F 109077 (1)

62 SECAMINE HYDROCHLORIDE (1)

63 SIROLIMUS (1)

64 TERT-BUTYL (S)-3-(TERT-BUTYLCARBAMOYL) PIPERAZINE-1-CARBOXYLATE (1)

65 THYMIDINE (1)

66 TOLRESTAT AND ITS INTERMEDIATES (1)

67 TOSITUMOMAB [MURINE MONOCLONAL ANTIBODY (B1) AGAINST B LYMPHOCYTES (CD20)] (1)

68 TP4 (1)

69 TRANYLCYPROMINE SULFATE (1)

70 TRIAMTERENE, USP (1)

71 TRIMEPRAZINE TARTRATE (1)

72 TRIPROLIDINE HYDROCHLORIDE (2)

73 VOCLOSPORIN (1)

74 VOCLOSPORIN (IE-001) (1)

75 [3-(4-BROMOBENZYL)-2-BUTYL-5-CHLORO-3H-IMIDAZOL-4-YL]METHANOL, (MEOL) (1)

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01 ABGENIX INC (1)

02 LONZA AG (18)

03 LONZA BIOLOGICS PLC (8)

04 LONZA BIOTEC SRO (3)

05 LONZA BRAINE SA (1)

06 LONZA INC (17)

07 LONZA LTD (19)

08 LONZA RIVERSIDE (9)

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01 Switzerland (51)

02 U.S.A (25)

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01 Active (10)

02 Inactive (66)

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01 Complete (1)

02 Blank (75)

URL Supplier Web Content
LONZA LTD
Inactive
12137
N/A
1996-09-16
II
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LONZA RIVERSIDE
Inactive
4212
N/A
1981-07-17
II
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LONZA RIVERSIDE
Inactive
10590
N/A
1993-11-22
II
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LONZA INC
Inactive
4012
N/A
1980-12-15
II
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LONZA INC
Inactive
4079
N/A
1981-01-21
II
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LONZA INC
Inactive
2860
N/A
1977-02-15
II
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LONZA INC
Inactive
4387
N/A
1981-11-23
II
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LONZA AG
Inactive
15740
N/A
2001-11-15
II
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LONZA LTD
Inactive
15729
N/A
2001-11-15
II
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LONZA BRAINE SA
Inactive
7493
N/A
1988-04-30
II
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