Our products / APIs
Vancomycin hydrochloride - Copenhagen
Vancomycin hydrochloride is a glycopeptide antibiotic active against a wide variety of gram-positive bacteria, most important being staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains), but also active against diphtheroids, enterococci (e.g. Enterococcus faecalis), Streptococcus bovis, and viridans group streptococci.
Indication: Used in the treatment of lower respiratory tract infections, septicemia, bone, skin, and skin structure infections, and infective endocarditis due to severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used because of intolerance or drug resistance. May be administered orally for treating antibiotic-associated pseudomembranous colitis produced by Clostridium difficile and for staphylococcal enterocolitis.
Application: Administered systemically as intravenous infusions and as capsules for oral administration. IV form can also be used orally for the treatment of antibiotic-associated pseudomembranous colitis and staphylococcal enterocolitis.
Downloadables
Product grades
Sterile, non-micronized
Non-sterile, non-micronized
Packaging sizes
Sterile, non-micronized
0.5 kgA (Kilogram Activity)
3 kgA (Kilogram Activity)
8 kgA (Kilogram Activity)
Non-sterile, non-micronized
0.5 kgA (Kilogram Activity)
3 kgA (Kilogram Activity)
8 kgA (Kilogram Activity)
10 kgA (Kilogram Activity)
Packaging material
Primary: Aluminum containers with PE insert and polypropylene lid
Secondary: Polystyrene
Shelf life
2 years (according to Ph. Eur.)
3 years (according to USP)
Storage conditions
Store refrigerated (2-8°C/36-46°F)
Compliance
Ph. Eur., USP
Manufacturing site
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered
EU GMP issued by Danish Medicines Agency
US FDA
Other health authorities
Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Japan Drug Master File (JDMF)
Vancomycin hydrochloride – sterile DMF available in selected markets outside US/EU/Japan
Want to hear more about our products?