Xelia Bacitracin Zinc

Xelia Bacitracin Zinc is composed of a group of polypeptides with antibiotic activity against a variety of Gram-positive bacteria including staphylococci. The zinc complex adds stability to the component, making bacitracin zinc more stable compared to bacitracin.

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

Dosage Form: Creams, Ointments, Powder & Powder Blends

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Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Features
  • Product grades :Sterile, micronized Non-sterile, micronized Non-sterile, non-micronized
  • Manufacturing site: Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) CMO for 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

Applications & Uses

Applications

Administered typically as combination drug product used in topical creams, powders, ointments and solutions.

Properties

Physical Form

Regulatory & Compliance

Compliance

Ph. Eur.
USP

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP) - non-sterile only

US Drug Master File (DMF)
Letter of Access (LoA)

Packaging & Availability

Packaging Type
Packaging sizes
  • Sterile non-micronized

 750 g

  • 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: 5 years
Sterile: EU (36 months), US (48 months)

Storage conditions

Below 25°C (77°F)