KD PHARMA BEXBACH GMBH

Overview

KD PHARMA BEXBACH GMBH is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering EICOSAPENTAENOIC ACID ETHYL ESTER; EPA 550/DHA 200 FFA; OMEGA-3 ACIDS ETHYL ESTERS USP.

API / Drug Master Files

KD PHARMA BEXBACH 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.

• EPA 550/DHA 200 FFAActive2014-03-31
• EICOSAPENTAENOIC ACID ETHYL ESTERActive2013-02-26
• OMEGA-3 ACIDS ETHYL ESTERS USPActive2008-11-07
• OMEGA-3-ACIDS ETHYL ESTERInactive2010-07-12

FDA compliance signals

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