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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances PHARMAZELL GMBH is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

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.