ZACH SYSTEM SA

Overview

ZACH SYSTEM SA is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering ABIRATERONE ACETATE; BOSENTAN MONOHYDRATE; LOTEPREDNOL ETABONATE; METHOXY-C15-WITTIG SALT (TGN05), INTERMEDIATE FOR ACITRETIN API.

API / Drug Master Files

ZACH SYSTEM SA holds 4 active (10 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.

• ABIRATERONE ACETATEActive2014-07-07
• BOSENTAN MONOHYDRATEActive2011-05-09
• METHOXY-C15-WITTIG SALT (TGN05), INTERMEDIATE FOR ACITRETIN APIActive2007-12-03
• LOTEPREDNOL ETABONATEActive1994-09-26
• VENLAFAXINE HYDROCHLORIDEInactive1997-01-29
• FELBAMATEInactive1991-07-17
• 1,3 PROPANEDIOL 2 PHENYLInactive1991-06-11
• 4-METHOXY-2,3,6-TRIMETHYLBENZALDEHYDEInactive1991-05-03
• MILNACIPRANInactive1991-04-19
• PAROXETINE STAGE 2 DL-AMINO ALCOHOLInactive1989-04-18

FDA compliance signals

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