FRESENIUS KABI AUSTRIA GMBH

Overview

FRESENIUS KABI AUSTRIA GMBH is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering LACTULOSE CONCENTRATE USP; LACTULOSE CRYSTALS; LACTULOSE SOLUTION USP.

API / Drug Master Files

FRESENIUS KABI AUSTRIA GMBH holds 3 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.

• LACTULOSE CONCENTRATE USPActive2007-05-29
• LACTULOSE SOLUTION USPActive2001-02-16
• LACTULOSE CRYSTALSActive2001-02-16
• LACTULOSE SOLUTION USPInactive2008-12-20

FDA compliance signals

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