PUROLITE LLC

Overview

PUROLITE LLC is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering CHOLESTYRAMINE RESIN USP; POLACRILIN POTASSIUM; PUROMILL PM5000; SODIUM POLYSTYRENE SULFONATE.

API / Drug Master Files

PUROLITE LLC holds 4 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.

• PUROMILL PM5000Active2019-03-08
• POLACRILIN POTASSIUMActive1989-02-21
• CHOLESTYRAMINE RESIN USPActive1988-02-05
• SODIUM POLYSTYRENE SULFONATEActive1985-06-27

FDA compliance signals

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