ERREGIERRE SPA

Overview

ERREGIERRE SPA is an active pharmaceutical ingredient (API) supplier with 25 active FDA Type II Drug Master Files, covering ARIPIPRAZOLE USP-EP; BISACODYL USP-EP; BUPROPION HYDROCHLORIDE USP; BUTENAFINE HYDROCHLORIDE; CICLOPIROX OLAMINE USP-PH.EUR.; CICLOPIROX USP-EP.

API / Drug Master Files

ERREGIERRE SPA holds 25 active (59 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.

• IMIDAZOLYL ETHANAMIDE PENTANDIOIC ACIDActive2017-04-07
• ZILEUTON USPActive2013-03-15
• N-[4-(TRIFLUOROMETHYL)BENZYL]-4-METHOXYBUTYRAMIDEActive2012-03-27
• RIVASTIGMINEActive2011-12-22
• MESALAMINE USP - PH.EUR. (HIGH DENSITY)Active2011-04-26
• TOLTERODINE TARTRATEActive2007-04-24
• RIVASTIGMINE TARTRATEActive2007-01-29
• NABUMETONE USPActive2006-03-07
• BUTENAFINE HYDROCHLORIDEActive2005-08-16
• ARIPIPRAZOLE USP-EPActive2005-08-15
• CICLOPIROX OLAMINE USP-PH.EUR.Active2003-01-02
• CICLOPIROX USP-EPActive2002-12-30
• NISOLDIPINEActive2002-10-22
• RALOXIFENE HYDROCHLORIDEActive2002-04-10
• SULCONAZOLE NITRATE USPActive2000-07-31

Showing 15 of 59 Drug Master Files.

FDA compliance signals

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