Xelia Colistimethate Sodium

Xelia Colistimethate Sodium is a derivative of colistin (polymyxin E) that is a mixture of polypeptide antibiotics active against Gramnegative bacteria, including Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Functions: Anti-Microbial Agent, Antibiotic

Dosage Form: Injectables

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

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Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Features

Product grades: Sterile, micronized .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 Other health authorities

Applications & Uses

Dosage Form
Applications

Administered systemically as intramuscular injections and intravenous injections or infusions. Colistimethate
sodium can also be administered by inhalation or mixed with bone cement, as well used in ophthalmic formulations.

Properties

Physical Form

Regulatory & Compliance

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, micronized
10 BOU*
100 BOU*
Sterile, non-micronized
15 BOU*
65 BOU*
Non-sterile, non-micronized
15 BOU*
65 BOU*

Packaging material

Primary: Almuinum containers with polyethylene insert and polypropylene lid
Secondary: Polystyrene

Storage & Handling

Shelf-life

5 years

Storage conditions

Below 25°C (77°F)