Our products / APIs
Vancomycin hydrochloride - Budapest
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
Non-sterile, non-micronized
Packaging sizes
Packaging size can be discussed with your Sales Representative
Packaging material
Primary: Aluminum bag laminated with Polyethylene, heat sealed
Secondary: Same as primary
Shelf life
3 years
Storage conditions
Store refrigerated (2-8°C/36-46°F)
Compliance
Ph. Eur., USP, JP
Manufacturing site
Xellia Pharmaceuticals Ltd., Budapest, Hungary
Release site
Xellia Pharmaceuticals Ltd., Budapest, Hungary
Site registered
EU GMP issued by Hungarian National Institute of Pharmacy recognized by FDA from March 1st 2018 according to Mutual Recognition Agreement (MRA)
Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Japan Drug Master File (JDMF)
DMF also available in other selected countries outside EU/US/Japan
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