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Vancomycin Hydrochloride

(manufactured in Budapest, Hungary)

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.

Product grades

Non-sterile, non-micronized


Ph. Eur.



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


Regulatory documentation

EU Drug Master File (DMF)

Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Agreed upon with customer

Packaging material

Primary: Aluminum bag laminated with Polyethylene, heat sealed

Secondary: same as primary

Shelf life

2 years (according to Ph. Eur.)

3 years (according to USP)

Storage conditions

Below 8°C (46°F)