Xelia Vancomycin Hydrochloride (Budapest)

Xelia Vancomycin Hydrochloride (Budapest) 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.

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Dosage Form: Capsules

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Features & Benefits

Features

Product grades: Non-sterile, non-micronized
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, US FDA

Applications & Uses

Markets
Applications
Dosage Form
Applications

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.

Properties

Physical Form

Regulatory & Compliance

Certifications & Compliance
Grade
Compliance

Ph. Eur.
USP
JP

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
Letter of Access (LoA)

Packaging & Availability

Packaging Type
Packaging sizes

Agreed upon with customer

Packaging material

Primary: Aluminum bag laminated with Polyethylene, heat sealed
Secondary: Same as primary

Storage & Handling

Storage conditions

2 years (according to EU)
3 years (according to US)

Storage conditions

Below 8°C (46°F)