FIS FABBRICA ITALIANA SINTETICI SPA

Overview

FIS FABBRICA ITALIANA SINTETICI SPA is an active pharmaceutical ingredient (API) supplier with 43 active FDA Type II Drug Master Files, covering ACETYLCYSTEINE, USP; CARBAMAZEPINE; CHLORDIAZEPOXIDE HCL; CLOBAZAM; CLOMIPHENE CITRATE; CLONAZEPAM.

API / Drug Master Files

FIS FABBRICA ITALIANA SINTETICI SPA holds 43 active (65 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• SAFINAMIDEActive2018-02-07
• ENCLOMIPHENE CITRATEActive2017-05-25
• PENTAZOCINEActive2016-04-20
• INDOMETHACIN SODIUMActive2015-09-30
• DORZOLAMIDE HYDROCHLORIDE (ALTERNATIVE PROCESS)Active2015-07-24
• PRASTERONE ACETATEActive2013-09-20
• OLOPATADINE HYDROCHLORIDEActive2012-08-02
• MIDAZOLAM HCIActive2011-08-01
• IMATINIB MESYLATE (ALPHA FORM)Active2011-07-27
• IMATINIB MESYLATE (BETA FORM)Active2011-07-26
• CLOBAZAMActive2011-02-28
• ELETRIPTAN HYDROBROMIDEActive2010-12-29
• NEBIVOLOL HYDROCHLORIDEActive2009-03-31
• PROGESTERONEActive2008-11-20
• NITROFURANTOIN MONOHYDRATE (CODE 1042-1026)Active2008-08-05

Showing 15 of 65 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to FIS FABBRICA ITALIANA SINTETICI SPA in our records. PharmaTek screens the full directory against live FDA enforcement data.