PHARMAZELL GMBH

Overview

PHARMAZELL GMBH is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE); BALSALAZIDE DISODIUM; CHOLIC ACID; METHYLENE BLUE USP; N-ACETYL-L-CYSTEINE; PROPAFENONE HYDROCHLORIDE.

API / Drug Master Files

PHARMAZELL GMBH holds 8 active (11 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.

• CHOLIC ACIDActive2025-05-23
• URSODIOLActive2024-12-18
• METHYLENE BLUE USPActive2023-09-21
• TERIFLUNOMIDEActive2016-03-10
• BALSALAZIDE DISODIUMActive2003-02-17
• PROPAFENONE HYDROCHLORIDEActive1993-12-16
• 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)Active1989-05-09
• N-ACETYL-L-CYSTEINEActive1985-03-29
• CARBAMAZEPINE (PROCESS II)Inactive2009-12-01
• CARBAMAZEPINEInactive2007-03-26
• L-LYSINE-N-ACETYLCYSTEINATEInactive1992-09-15

FDA compliance signals

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