5N PLUS LUBECK GMBH

Overview

5N PLUS LUBECK GMBH is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering BISMUTH SUBCITRATE POTASSIUM; BISMUTH SUBSALICYLATE; BISMUTH SUBSALICYLATE SG; BISMUTH SUBSALICYLATE SG FINE.

API / Drug Master Files

5N PLUS LUBECK GMBH 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.

• BISMUTH SUBSALICYLATE SG FINEActive2021-12-15
• BISMUTH SUBCITRATE POTASSIUMActive2017-09-06
• BISMUTH SUBSALICYLATE SGActive2002-12-23
• BISMUTH SUBSALICYLATEActive1992-04-20
• BISMUTH CITRATEInactive1992-01-07

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to 5N PLUS LUBECK GMBH in our records. PharmaTek screens the full directory against live FDA enforcement data.