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

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01 ADAPALENE (MED-200025/E) (1)

02 AMBRISENTAN (MED-200028/M) (1)

03 AMOXAPINE (1)

04 APIXABAN (1)

05 BRIMONIDINE TARTRATE (1)

06 CAPTOPRIL (1)

07 CHLORHEXIDINE ACETATE (1)

08 CHLORHEXIDINE BASE (1)

09 CHLORHEXIDINE DIHYDROCHLORIDE (1)

10 CHLORHEXIDINE GLUCONATE (1)

11 CHLORHEXIDINE GLUCONATE SOLUTION (DGLP) (1)

12 CINACALCET HYDROCHLORIDE (MED-200140/M ) (1)

13 CLOZAPINE (1)

14 CYCLOBENZAPRINE HCL (1)

15 EDARAVONE (1)

16 ENALAPRIL MALEATE (1)

17 FELODIPINE (1)

18 FLUVOXAMINE MALEATE (1)

19 GUANFACINE HYDROCHLORIDE (1)

20 LAMOTRIGINE (1)

21 LOFEXIDINE HYDROCHLORIDE (1)

22 LOXAPINE BASE (1)

23 LOXAPINE SUCCINATE (1)

24 MED-200056/E (1)

25 MED-200400/M (Desvenlafaxine Succinate) (1)

26 MED-201345/E (1)

27 MED-201890/E (1)

28 MED-201950/E (VORICONAZOLE) (1)

29 MED-300006/E (INTERMEDIATE) (1)

30 MEXILETINE HYDROCHLORIDE (1)

31 MICAFUNGIN SODIUM (1)

32 MIRTAZAPINE (1)

33 NEPAFENAC (1)

34 PAROXETINE HYDROCHLORIDE HEMIHYDRATE (1)

35 PAZOPANIB HYDROCHLORIDE (1)

36 PIMECROLIMUS (MED 201445/E) (1)

37 PRUCALOPRIDE SUCCINATE (1)

38 QUETIAPINE FUMARATE (1)

39 REVEFENACIN (1)

40 RIVAROXABAN (1)

41 SUGAMMADEX SODIUM (1)

42 SUNITINIB MALATE (1)

43 TAMSULOSIN HYDROCHLORIDE (MED-201750/E) (1)

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01 MEDICHEM MANUFACTURING (MALTA) LTD (1)

02 MEDICHEM MANUFACTURING MALTA LTD (12)

03 MEDICHEM SA (30)

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01 Malta (4)

02 Spain (39)

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01 Active (43)

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01 Complete (33)

02 Blank (10)

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