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

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01 1,2 -DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL SODIUM SALT (DMPG, NA) (1)

02 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOPHATIDIC ACID SODIUM SALT (DPPA, NA) (1)

03 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DPPC) (1)

04 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC) (1)

05 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (POPC) (1)

06 1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL SODIUM SALT (POPG NA) (1)

07 7-AMINOCEPHALOSPORANIC ACID, ENZYMATIC (1)

08 AFAMELANOTIDE BULK DRUG SUBSTANCE (1)

09 AMOXICILLIN (1)

10 AMPICILLIN (1)

11 AMPICILLIN TRIHYDRATE STERILE (1)

12 ATN 161 BULK DRUG SUBSTANCE (1)

13 B.P. 102 (1)

14 BALSALAZIDE DISODIUM DIHYDRATE (1)

15 BENZOYL PEROXIDE, HYDROUS (1)

16 BETHANECHOL CHLORIDE (1)

17 BISOPROLOL FUMARATE (1)

18 Benzphetamine Hydrochloride (1)

19 CARBADOX (1)

20 CARBAMAZEPINE (1)

21 CEFADROXIL (1)

22 CEFEPIME/L-ARGININE STERILE BLEND (1)

23 CEPHAPIRIN BENZATHINE (1)

24 CEPHAPIRIN SODIUM (1)

25 CETRORELIX ACETATE BULK DRUG SUBSTANCE (1)

26 CHLORTHALIDONE (1)

27 CHOLINE FENOFIBRATE DRUG SUBSTANCE (1)

28 CICLOPIROX (1)

29 CIMETIDINE (1)

30 CIMETIDINE HYDROCHLORIDE (1)

31 CLOTRIMAZOLE (1)

32 DESIPRAMINE HYDROCHLORIDE USP (1)

33 DICLOFENAC POTASSIUM (1)

34 DICLOFENAC SODIUM (1)

35 DISULFIRAM (1)

36 DOXYLAMINE SUCCINATE (1)

37 EPTIFIBATIDE (BULK) (1)

38 FACILITIES AND OPERATING PROCEDURES IN BRUSSELS, BELGIUM (1)

39 FENOFIBRATE (1)

40 FENOFIBRATE INTERMEDIATE DRUG SUBSTANCE (1)

41 GLATIRAMER ACETATE (1)

42 GUANETHIDINE SULFATE, USP (1)

43 IMIPRAMINE HCL USP (1)

44 IMIPRAMINE PAMOATE (1)

45 L-ARGININE (1)

46 LARAZOTIDE (1)

47 LINACLOTIDE (1)

48 LUTETIUM (177LU) CHLORIDE SOLUTION FOR RADIOLABELING (NO-CARRIER-ADDED) (1)

49 LY297141 (1)

50 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

51 MESALAMINE (1)

52 MESALAMINE HIGH DENSITY (1)

53 METAXALONE (1)

54 METHYLDOPA (1)

55 METRONIDAZOLE USP (1)

56 MICONAZOLE BASE (1)

57 MICONAZOLE NITRATE (1)

58 N-METHYL-1-METHYLTHIO-2-NITRO ETHENAMINE, TREVIGLIO, ITALY (1)

59 NAFCILLIN SODIUM STERILE (1)

60 NAPROXEN SODIUM USP (1)

61 NAPROXEN USP (1)

62 NEBIVOLOL HYDROCHLORIDE (1)

63 OLSALAZINE SODIUM (1)

64 OMIGANAN PENTAHYDROCHLORIDE BULK DRUG SUBSTANCE (1)

65 OXACILLIN SODIUM (1)

66 OXAPROZIN (1)

67 OXCARBAZEPINE (1)

68 OXYBUTYNIN HYDROCHLORIDE (1)

69 PHENTOLAMINE MESYLATE (1)

70 PIPERACILLIN MONOHYDRATE (1)

71 QUETIAPINE FUMARATE (1)

72 RANITIDINE HYDROCHLORIDE (1)

73 SECNIDAZOLE (1)

74 SULFASALAZINE (1)

75 TETRABENAZINE (1)

76 TINIDAZOLE USP XXI (1)

77 TIZANIDINE HYDROCHLORIDE (1)

78 TRIAMTERENE, USP (1)

79 TRIMETHOBENZAMIDE HCI (1)

80 VALGANCICLOVIR HYDROCHLORIDE (1)

81 VAPREOTIDE ACETATE (1)

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01 AMNEAL PHARMACEUTICALS LLC (1)

02 CORDEN BIOCHEM GMBH (1)

03 CORDEN PHARMA BERGAMO SPA (17)

04 CORDEN PHARMA BRUSSELS SA (5)

05 CORDEN PHARMA CHENOVE (7)

06 CORDEN PHARMA COLORADO INC (2)

07 CORDEN PHARMA LATINA SPA (11)

08 CORDEN PHARMA SWITZERLAND LLC (7)

09 CORDEN PHARMACHEM (1)

10 ECKERT AND ZIEGLER RADIOPHARMA GMBH (1)

11 FARCHEMIA SRL (19)

12 PEPTISYNTHA SA (3)

13 PHIBRO ANIMAL HEALTH CORP (1)

14 RISING PHARMA HOLDINGS INC (1)

15 SYNKEM DIV PLASTO SA (2)

16 SYNKEM SAS (2)

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01 Belgium (9)

02 France (9)

03 Germany (5)

04 Italy (49)

05 Switzerland (7)

06 U.S.A (2)

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01 Active (33)

02 Inactive (48)

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01 Complete (10)

02 Blank (71)

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CORDEN PHARMA SWITZER...
Active
31533
N/A
2017-03-21
II
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CORDEN PHARMA SWITZER...
Inactive
13189
N/A
1998-09-08
II
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CORDEN PHARMA SWITZER...
Active
12555
N/A
1997-06-23
II
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CORDEN PHARMA SWITZER...
Active
14970
N/A
2000-07-31
II
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CORDEN PHARMA SWITZER...
Active
14694
N/A
2000-02-15
II
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CORDEN PHARMA SWITZER...
Active
14429
N/A
1999-09-28
II
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CORDEN BIOCHEM GMBH
Inactive
12440
N/A
1997-03-24
II
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CORDEN PHARMA BRUSSEL...
Active
17471
N/A
2004-06-17
II
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CORDEN PHARMA LATINA ...
Inactive
13498
N/A
1998-09-01
II
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CORDEN PHARMA LATINA ...
Inactive
13435
N/A
1998-09-01
II
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