BIOCARE PHARMACEUTICAL LTD

Overview

BIOCARE PHARMACEUTICAL LTD is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering DASATINIB; DEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCE; FLUDARABINE PHOSPHATE (REFINED); SODIUM SALICYLATE NON-STERILE BULK DRUG SUBSTANCE.

API / Drug Master Files

BIOCARE PHARMACEUTICAL LTD 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.

• FLUDARABINE PHOSPHATE (REFINED)Active2020-09-09
• DASATINIBActive2019-03-19
• SODIUM SALICYLATE NON-STERILE BULK DRUG SUBSTANCEActive2018-08-21
• DEXRAZOXANE, NON-STERILE BULK DRUG SUBSTANCEActive2008-04-17

FDA compliance signals

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