Xelia Colistin Sulfate

Xelia Colistin Sulfate is a mixture of the sulfates of polypeptide antibiotics active against Gram-negative bacteria.

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

Dosage Form: Suspension

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Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Features

Product grades : Non-sterile, non-micronized
Manufacturing site : Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site:  Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Site registered  : EU GMP certificate , US FDA, Other health authorities

Applications & Uses

Dosage Form
Applications

Administered topically in the treatment of local infections, mainly external ear infections. Often formulated as otic
suspensions and solutions

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

10 BOU*
150 BOU*

Packaging material

Primary: Aluminum containers with a polyethylene insert and polypropylene lid
Secondary: Polystyrene

Storage & Handling

Shelf-life

EU: 36 months
US: 48 months

Storage conditions

Below 25°C (77°F)