EUTICALS SPA

Overview

EUTICALS SPA is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering ADENOSINE; DIACEREIN (PROCESS II); LITHIUM CARBONATE PHARMA GRADE.

API / Drug Master Files

EUTICALS SPA holds 3 active (10 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.

• DIACEREIN (PROCESS II)Active2010-07-13
• LITHIUM CARBONATE PHARMA GRADEActive2009-10-07
• ADENOSINEActive2008-11-25
• BUSULFANInactive2011-10-18
• BENDAMUSTINE HYDROCHLORIDE HYDRATEInactive2011-10-18
• AZACITIDINEInactive2011-09-07
• GEMCITABINE HYDROCHLORIDEInactive2010-02-12
• RIBAVIRINInactive2009-08-03
• HYDRALAZINE HYDROCHLORIDE INJECTABLE GRADEInactive2009-03-20
• FLUDARABINE PHOSPHATEInactive2004-05-13

FDA compliance signals

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