EXCELLA GMBH AND CO KG

Overview

EXCELLA GMBH AND CO KG is an active pharmaceutical ingredient (API) supplier with 27 active FDA Type II Drug Master Files, covering ACYCLOVIR SODIUM; ADAPALENE; ANASTROZOLE; BACLOFEN; BICALUTAMIDE MILLED Z; BUPIVACAINE HYDROCHLORIDE.

API / Drug Master Files

EXCELLA GMBH AND CO KG holds 27 active (32 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.

• MASITINIB MESYLATEActive2017-01-10
• TEMOZOLOMIDEActive2012-08-16
• DEFEROXAMINE MESYLATE USPActive2012-03-01
• LEVOTHYROXINE SODIUMActive2011-10-20
• MASITINIB MESYLATEActive2011-03-30
• CEVIMELINE HYDROCHLORIDEActive2008-11-17
• LANTHANUM CARBONATEActive2008-10-17
• BICALUTAMIDE MILLED ZActive2008-08-04
• BUPIVACAINE HYDROCHLORIDEActive2007-12-20
• MYCOPHENOLATE MOFETIL SIEVEDActive2007-11-28
• R-BACLOFENActive2007-09-25
• ANASTROZOLEActive2007-03-09
• ADAPALENEActive2006-02-09
• DEFEROXAMINE MESYLATEActive2005-06-27
• ROPIVACAINE HYDROCHLORIDEActive2005-04-15

Showing 15 of 32 Drug Master Files.

FDA compliance signals

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