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

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01 2 BROMOACETAMIDO-5 CHLORO-2' FLUOROBENZOPHENONE (1)

02 ABIRATERONE ACETATE USP (1)

03 ABIRATERONE ACETATE USP (NP) (1)

04 ACETYL OXIDE (OXAZEPAM INTERMEDIATE) (1)

05 AMITRIPTYLINE HCL (1)

06 AMITRYPTILINE HCL (1)

07 BELLAFOLINE SUBSTANCE 60% (1)

08 BENZBROMARONE BULK (1)

09 BIMATOPROST (1)

10 BRINZOLAMIDE, USP (1)

11 BUDESONIDE (1)

12 BUDESONIDE USP (1)

13 BUMETANIDE (1)

14 BUSPIRONE HYDROCHLORIDE (1)

15 CHLOROTHIAZIDE (BULK) - HYDROCHLOROTHIAZIDE (1)

16 CHLORTHALIDONE (1)

17 CLOFIBRATE USP (1)

18 CLORAZEPATE DIPOTASSIUM, BULK FORM (1)

19 DALFAMPRIDINE (1)

20 DESOGESTREL (1)

21 DESOGESTREL CN (1)

22 DEXBROMPHENIRAMINE MALEATE USP. XX (1)

23 DEXCHLORPHENIRAMINE MALEATE (1)

24 DEXTRO-PROPOXYPHENE HCL (1)

25 DIENOGEST (1)

26 DIPHENHYDRAMINE HCL & DIMENHYDRINATE (1)

27 DIPYRIDAMOLE (1)

28 DISOPYRAMIDE PHOSPHATE AND DISOPYRAMIDE BASE (1)

29 DOFETILIDE USP (1)

30 DROPERIDOL (1)

31 DROSPIRENONE USP (1)

32 ECONAZOLE NITRATE (1)

33 EPLERENONE (1)

34 EPLERENONE PH. EUR. (1)

35 ETHINYLESTRADIOL USP (1)

36 ETONOGESTREL (1)

37 FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN VARESE,ITALY (1)

38 FLUOXETINE HYDROCHLORIDE (1)

39 FLUTICASONE PROPIONATE USP (1)

40 FORMOTEROL FUMARATE DIHYDRATE MICRONIZED (1)

41 FORMOTEROL FUMARATE DIHYDRATE USP (1)

42 FULVESTRANT USP (1)

43 IBUPROFEN (1)

44 IBUPROFEN USP (1)

45 IDEBENONE (1)

46 INDAPAMIDE (1)

47 INDOMETHACIN (1)

48 ISOSORBIDE DINITRATE (1)

49 IVERMECTIN PH. FUR. (1)

50 LATANOPROST (1)

51 LEVONORGESTREL USP (1)

52 LOTEPREDNOL ETABONATE (1)

53 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SARONNO, ITALY (1)

54 MANUFACTURING SITE, PERSONNEL, FACILITIES, AND GENERAL OPERATING PROCEDURES AT MILANO, ITALY. (1)

55 MECLIZINE HCL (1)

56 MEMANTINE HYDROCHLORIDE USP (1)

57 METAPROTERENOL SULPHATE USP (1)

58 MIDODRINE HYDROCHLORIDE (1)

59 MOMETASONE FUROATE (1)

60 NITAZOXANIDE (1)

61 NORGESTIMATE USP (1)

62 NORGESTIMATE USP (NP) (1)

63 OBETICHOLIC ACID (1)

64 OXPRENOLOL HcL (1)

65 PENTAZOCINE HYDROCHLORIDE (1)

66 PERSONNEL, FACILITIES AND CONTROLS(GENERAL OPERATING PROCEDURES) (1)

67 PHENTOLAMINE MESILATE USP (1)

68 PINDOLOL (1)

69 PROCHLORPERAZINE MALEATE (1)

70 PROGESTERONE USP (1)

71 PROPRANOLOL HCL (1)

72 PROPRANOLOL HCL. (1)

73 QUINIDINE BASE/SULPHATE/GLUCONATE AND POLIGALACTURONATE (1)

74 SULFAMETHOXAZOLE (1)

75 TERBUTALINE SULFATE (1)

76 TERFENADINE (2)

77 THIOTHIXENE BASE AND HC1 (1)

78 TIOTROPIUM BROMIDE (1)

79 TRIMETHOBENZAMIDE HCL USP (1)

80 ULIPRISTAL ACETATE (1)

81 ZOPICLONE (1)

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01 INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA (7)

02 INDUSTRIA CHIMICA MILANESE SPA (7)

03 INDUSTRIA CHIMICA PROFARMACO SPA (4)

04 INDUSTRIALE CHIMICA SRL (43)

05 INDUSTRIAS QUIMICAS ESTEVE SA (2)

06 INDUSTRIAS QUIMICAS TAUBATE SA (1)

07 INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPA (17)

08 INDUSTRIE CHIMICHE ITALIANE SPA (1)

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01 Italy (82)

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01 Active (38)

02 Inactive (44)

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01 Complete (27)

02 Blank (55)

URL Supplier Web Content
INDUSTRIA CHIMICA PRO...
Inactive
4696
N/A
1982-10-18
II
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INDUSTRIALE CHIMICA S...
Active
28701
Complete
2015-01-05
2014-10-14
2014-10-08
II
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INDUSTRIALE CHIMICA S...
Active
34320
Complete
2020-02-19
2019-12-06
2019-12-12
II
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INDUSTRIA CHIMICA PRO...
Inactive
5268
N/A
1983-10-20
II
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INDUSTRIA CHEMICA PRO...
Inactive
3449
N/A
1979-02-26
II
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INDUSTRIA CHIMICA MIL...
Inactive
2535
N/A
1975-10-06
II
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INDUSTRIA CHIMICA PRO...
Inactive
2903
N/A
1977-03-22
II
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INDUSTRIALE CHIMICA S...
Active
23480
Complete
2013-07-31
2013-07-19
2010-01-26
II
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INDUSTRIALE CHIMICA S...
Active
25918
Complete
2014-01-08
2012-11-20
2012-03-28
II
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INDUSTRIALE CHIMICA S...
Inactive
15877
N/A
2002-04-03
II
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