PATHEON AUSTRIA GMBH AND CO KG

Overview

PATHEON AUSTRIA GMBH AND CO KG is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering COLESEVELAM HYDROCHLORIDE; NEOSTIGMINE METHYLSULFATE; PYRIDOSTIGMINE BROMIDE; SILVER SULFADAZINE.

API / Drug Master Files

PATHEON AUSTRIA GMBH AND CO KG holds 4 active (5 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.

• COLESEVELAM HYDROCHLORIDEActive2014-12-19
• SILVER SULFADAZINEActive2013-11-11
• NEOSTIGMINE METHYLSULFATEActive2011-03-16
• PYRIDOSTIGMINE BROMIDEActive1993-11-30
• SECONDARY AMINE HCLInactive2003-12-22

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to PATHEON AUSTRIA GMBH AND CO KG in our records. PharmaTek screens the full directory against live FDA enforcement data.