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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Lonza Group 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 AURANOFIN (1)

04 BROENAC SODIUM SESQUIHYDRATE (1)

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

06 CN 28091 LACTOL-LACTAM (1)

07 CN 343 (SAS) (1)

08 CN25225 (METEXAFIN GADOLINIUM) (1)

09 CRUDE SG-3249 (1)

10 D5AA (1)

11 DEBMEB (1)

12 DESMOPRESSIN ACETATE (1)

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

14 EC-037 (1)

15 EC-125 DRUG SUBSTANCE (1)

16 EPROSARTAN (1)

17 EPROSARTAN MESYLATE (ROUTE F) (1)

18 EPROSARTAN MESYLATE (ROUTE F1) (1)

19 ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE) (1)

20 ETH06 (TRABECTEDIN INTERMEDIATE) (1)

21 ETODOLAC (1)

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

23 FLUVOXAMINE MALEATE (SV-006) (1)

24 HYDROXYAMPHETAMINE HYDROBROMIDE (1)

25 KETOSULFONE (1)

26 KW-2401 (1)

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

28 L-CARNITINE DIR (1)

29 L-CARNITINE USP (1)

30 LEVOCARNITINE TARTATE (1)

31 MC-VAL-ALA-PBD (1)

32 NIACIN USP GRANULAR SPECIAL (1)

33 NIACIN USP SPECIAL (1)

34 NIACINAMIDE (1)

35 NIACINAMIDE FOR ORAL USE (1)

36 PHENOXYBENZAMINE HCL (1)

37 PROCHLORPERAZINE, PROCHLORPERAZINE EDISYLATE,PROCHLORPERAZINE MALEATE (1)

38 PROPYLHEXEDRINE (1)

39 SB 200473 (1)

40 SB 201999 (1)

41 SB 217063 AND SK&F 109077 (1)

42 SECAMINE HYDROCHLORIDE (1)

43 SIROLIMUS (1)

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

45 THYMIDINE (1)

46 TP4 (1)

47 TRANYLCYPROMINE SULFATE (1)

48 TRIAMTERENE, USP (1)

49 TRIMEPRAZINE TARTRATE (1)

50 VOCLOSPORIN (1)

51 VOCLOSPORIN (IE-001) (1)

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01 ABGENIX INC (1)

02 LONZA AG (18)

03 LONZA BIOTEC SRO (3)

04 LONZA BRAINE SA (1)

05 LONZA LTD (19)

06 LONZA RIVERSIDE (9)

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01 Switzerland (51)

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01 Active (7)

02 Inactive (44)

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01 Complete (1)

02 Blank (50)

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 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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LONZA AG
Active
11932
N/A
1996-04-17
II
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LONZA LTD
Inactive
15475
N/A
2001-05-29
II
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LONZA LTD
Inactive
16790
N/A
2003-08-22
II
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LONZA AG
Inactive
18079
N/A
2005-02-09
II
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