Vancomycin Hydrochloride is a glycopeptide antibiotic active against a wide variety of Gram-positive bacteria, including Clostridium difficile, methicillin resistant (MRSA) and sensitive strains of Staphylococcus aureus (MRSA) and Streptococci.
Indication: Used in the treatment of severe systemic methicillin resistant (MRSA) and sensitive strains where other antibiotics cannot be used due to intolerance or drug resistance. May be administered orally for treatment of 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 Clostridium difficile infections.
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Non-sterile, non-micronized | ||
Compliance |
Ph. Eur. USP JP |
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Manufacturing site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Release site |
Xellia Pharmaceuticals Ltd., Budapest, Hungary |
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Site registered |
EU GMP issued by Hungarian National Institute of Pharmacy US FDA |
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Regulatory documentation |
EU Drug Master File (DMF) Certificate of Suitability (CEP) US Drug Master File (DMF) Letter of Access (LoA) |
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