Xelia Bacitracin

Xelia Bacitracin is composed of a group of polypeptides with antibiotic activity against a variety of Gram-positive bacteria including staphylococci.

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

Dosage Form: Creams, Injectables, Ointments, Powder & Powder Blends

Knowde Enhanced TDS

Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Features

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

Manufacturing site : Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterilization only)

Release site : Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterile)

Site registered : EU GMP issued by Danish Medicines Agency US FDA

Other documentation

Written confirmation for import into EU
Chinese Manufacturing License (Taizhou site)

Applications & Uses

Applications

Administered typically as a combination drug product used in topical creams, powders, ointments and
solutions. Bacitracin is also administered systemically as intramuscular 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 Type
Packaging sizes
  • Sterile non-micronized

750 g
2 kg

  • Non-sterile micronized & non-micronized

1 kg
5 kg
15 kg

Packaging material
  • Sterile non-micronized : 

Primary: Aluminum container with reinforced butyl lid and tear-off aluminum seal
Secondary: Polystyrene

  • Non-sterile micronized & non-micronized

Primary: Polyethylene bag closed with cable tie
Secondary: Heat sealed multi-layer laminated aluminum bag

Storage & Handling

Shelf-life

Non-sterile: 4 years
Sterile: 3 years

Storage conditions

Below 8°C (46°F)