Xelia Polymyxin B Sulfate

Xelia Polymyxin B Sulfateis mixture of the sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other serious Gram-negative bacteria.

Functions: Antibiotic, Disinfectant

Dosage Form: Eye Drops, 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 Non-sterile, micronized Non-sterile, 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

Applications

Administered systemically as intravenous infusions, intramuscular or intrathecal injections and locally as eye drops
or subconjunctival injections.

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

1 BOU*
5 BOU*
10 BOU*

  • Sterile Non-micronized

1 BOU*
10 BOU*

  • Non-sterile Micronized

1 BOU*
5 BOU*
10 BOU*
25 BOU*

  • Non-sterile Non-micronized

10 BOU*

Packaging material

Primary: Aluminum containers with PE insert and polypropylene lid
Secondary: Polystyrene

Storage & Handling

Shelf-life

Sterile: 24 months
Non-sterile: 5 years
USP grade for ROW and EP grade: 5 years

Storage conditions

Below 25°C (77°F)