Xellia Pharmaceuticals ApS

Overview

Xellia Pharmaceuticals ApS is a leading developer and supplier of critical care anti-infective therapies along with therapies for treating bacterial and antibiotic-resistant infections. The company operates a vertically integrated supply chain, ensuring control from research and development to manufacture.

Therapeutic areas

API / Drug Master Files

Xellia Pharmaceuticals ApS holds 19 active (23 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.

• DALBAVANCIN HYDROCHLORIDEActive2024-03-27
• VANCOMYCIN WET BASE, NON-STERILEActive2017-07-20
• BACITRACIN ZINC, STERILEActive2014-06-20
• DAPTOMYCIN NON-STERILEActive2013-07-16
• DAPTOMYCINActive2012-12-21
• VANCOMYCIN HYDROCHLORIDEActive2007-06-11
• GRAMICIDIN, USPActive2004-07-12
• TOBRAMYCIN SULPHATE, USP STERILE BULKActive2001-09-17
• TOBRAMYCIN SULPHATE, NON-STERILE BULKActive2000-09-12
• POLYMYXIN B SULFATEActive1999-06-10
• VANCOMYCIN HYDROCHLORIDEActive1998-09-01
• VANCOMYCIN HYDROCHLORIDEActive1998-09-01
• AMPHOTERICIN BActive1998-09-01
• BACITRACIN ZINC USP NON-STERILEActive1998-09-01
• BACITRACIN USP NON-STERILEActive1998-09-01

Showing 15 of 23 Drug Master Files.

FDA compliance signals