BIOFER SPA

Overview

BIOFER SPA is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering HEPARIN SODIUM; SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE.

API / Drug Master Files

BIOFER SPA holds 2 active (3 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.

• HEPARIN SODIUMActive2008-12-22
• SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEActive2004-10-07
• IRON SUCROSE INJECTIONInactive2005-01-12

FDA compliance signals

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