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

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01 7-KETOLITHOCHOLIC ACID (1)

02 AMINOCAPROIC ACID (1)

03 AMITRIPTYLINE HYDROCHLORIDE (1)

04 BENDROFLUMETHIAZIDE USP (1)

05 BUPROPION HCL (1)

06 BUPROPION HYDROBROMIDE (1)

07 CHENODEOXYCHOLIC ACID (1)

08 CHLORPROPAMIDE (1)

09 CILOSTAZOL (1)

10 CYCLOBENZAPRINE HCL (1)

11 CYPROHEPTADINE HCL, USP (1)

12 DAPSONE (1)

13 DEXLANSOPRAZOLE (1)

14 DEXLANSOPRAZOLE AMORPHOUS (1)

15 DEXLANSOPRAZOLE ANHYDROUS (2)

16 DIBENZOSUBERENONE (1)

17 DICLOFENAC EPOLAMINE (1)

18 DICLOFENAC POTASSIUM (1)

19 DICLOFENAC SODIUM EP/USP (1)

20 DOXEPIN HCl (1)

21 EFINACONAZOLE (1)

22 ENTACAPONE (1)

23 FESOTERODINE FUMARATE (1)

24 FEXOFENADINE HYDROCHLORIDE USP (1)

25 FEXOFENADINE HYDROCHLORIDE USP FORM A (1)

26 FEXOFENADINE HYDROCHLORIDE USP FORM l (1)

27 GILBENCLAMIDE/GLYBURIDE (1)

28 GLYCERIN TRINITRATE (NITROGLYCERIN-NG) (1)

29 GLYCERYL TRINITRATE SOLUTION (1)

30 HYDROFLUMETHIAZIDE USP (1)

31 IBUPROFEN LYSINE SALT (1)

32 ISOSORBIDE DINITRATE (ISDN) (1)

33 ISOSORBIDE-5-MONONITRATE (5-ISMN) (1)

34 MANDELATE SALT, INTERMEDIATE (1)

35 MIGLUSTAT (1)

36 MODAFINIL USP (1)

37 NIFEDIPINE USP (1)

38 NITISINONE (1)

39 NORTRIPTYLINE HCL (1)

40 PIRFENIDONE (1)

41 PIROXICAM (1)

42 PROTRIPTYLINE HYDROCHLORIDE (1)

43 RUFINAMIDE USP (1)

44 SAPROPTERIN DIHYDROCHLORIDE (1)

45 SAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS) (1)

46 SELEGILINE BASE (1)

47 SELEGILINE HYDROCHLORIDE (1)

48 SPIRONOLACTONE (1)

49 SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY (1)

50 TOLAZAMIDE (1)

51 TOLBUTAMIDE USP (1)

52 TRAMADOL HCL (1)

53 TRIAMTERENE USP (1)

54 URSODEOXYCHOLIC ACID (1)

55 VORTIOXETINE HYDROBROMIDE MONOHYDRATE (1)

56 ZONISAMIDE (1)

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01 DIPHARMA FRANCIS SPA (1)

02 DIPHARMA FRANCIS SRL (49)

03 DIPHARMA SA (4)

04 DIPHARMA SPA (3)

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01 Italy (55)

02 Switzerland (2)

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01 Active (44)

02 Inactive (13)

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01 Complete (33)

02 Blank (24)

URL Supplier Web Content
DIPHARMA FRANCIS SRL
Active
32475
N/A
2018-02-27
II
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DIPHARMA FRANCIS SRL
Active
31132
Complete
2017-09-21
2017-07-25
2016-12-14
II
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DIPHARMA FRANCIS SRL
Active
2908
N/A
1977-03-18
II
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DIPHARMA FRANCIS SRL
Inactive
6391
N/A
1986-05-09
II
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DIPHARMA FRANCIS SRL
Active
14534
Complete
2015-03-09
2015-03-04
1999-11-11
II
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DIPHARMA FRANCIS SRL
Inactive
22720
N/A
2009-04-14
II
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DIPHARMA FRANCIS SRL
Active
34160
Complete
2020-11-10
2020-10-29
2019-09-30
II
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DIPHARMA FRANCIS SRL
Inactive
3514
N/A
1979-03-02
II
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DIPHARMA FRANCIS SRL
Active
17050
Complete
2019-02-27
2019-02-25
2003-12-22
II
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DIPHARMA FRANCIS SRL
Active
5864
Complete
2015-06-23
2015-06-17
1985-06-06
II
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