OPOCRIN SPA

Overview

OPOCRIN SPA is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering FERRIC OXYHYDROXIDE WITH SUCROSE.

API / Drug Master Files

OPOCRIN SPA holds 1 active (4 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.

• FERRIC OXYHYDROXIDE WITH SUCROSEActive2018-08-09
• DALTEPARIN SODIUM BULKInactive2006-08-04
• SODIUM FERRIC GLUCONATEInactive2004-08-30
• ENOXAPARIN SODIUMInactive2003-08-08

FDA compliance signals

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