KANEKA EUROGENTEC SA

Overview

KANEKA EUROGENTEC SA is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering PRODUCTION OF PLASMID DNA; PRODUCTION OF PLASMID DNA (DRUG SUBSTANCE, VERSION 2); PRODUCTION OF PLASMID DNA VERSION 3; PRODUCTION OF PLASMID DNA VERSION 4; PRODUCTION OF PLASMID DNA, VERSION 5.

Core services & business areas

API / Drug Master Files

KANEKA EUROGENTEC SA holds 5 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.

• PRODUCTION OF PLASMID DNA, VERSION 5Active2019-10-17
• PRODUCTION OF PLASMID DNA VERSION 3Active2017-05-29
• PRODUCTION OF PLASMID DNA VERSION 4Active2017-05-29
• PRODUCTION OF PLASMID DNA (DRUG SUBSTANCE, VERSION 2)Active2015-02-25
• PRODUCTION OF PLASMID DNAActive2009-10-13

FDA compliance signals

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