PURAC BIOCHEM BV

Overview

PURAC BIOCHEM BV is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering SODIUM (S)-LACTATE SOLUTION 50%, 60% SODIUM LACTATE CONTENT.

API / Drug Master Files

PURAC BIOCHEM BV 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.

• SODIUM (S)-LACTATE SOLUTION 50%, 60% SODIUM LACTATE CONTENTActive2007-06-11
• AMMONIUM LACTATE, PURASAL NH 70Inactive1994-09-13
• CALCIUM GLUCONATEInactive1990-02-05
• ZINC GLUCONATEInactive1985-07-30

FDA compliance signals

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