Xelia Vancomycin Hydrochloride (Copenhage)

Identification & Functionality

Pharma & Nutraceuticals Functions

Anti-Microbial Agent,

Antibiotic

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Microbial Control & Preservation

Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors

Active Pharmaceutical Ingredients (APIs)

Features & Benefits

Features

Product grades : Sterile, non-micronized Non-sterile, non-micronized
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

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Capsules

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

Powder,

Solid

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

FDA Compliant,

GMP,

United States Pharmacopeia (USP)

Grade

Pharma Grade

Compliance

Ph. Eur.
USP

Regulatory documentation

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

Packaging & Availability

Packaging sizes

Sterile, non-micronized
0.5 kgA*
3 kgA*
8 kgA*
Non-sterile, non-micronized
0.5 kgA*
3 kgA*
8 kgA*
10 kgA*

Packaging material

Sterile, non-micronized
Primary: Aluminum containers with PE insert
and polypropylene lid
Secondary: Polystyrene
Non-sterile, non-micronized
Primary: Aluminum containers with PE insert and
polypropylene lid
Secondary: Polystyrene

Storage & Handling

Shelf-life

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

Storage conditions

Below 8°C (46°F)