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.

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances EUTICALS SPA is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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
  • BENDAMUSTINE HYDROCHLORIDE HYDRATEInactive2011-10-18
  • BUSULFANInactive2011-10-18
  • 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.

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