Our products / APIs
Bacitracin
Bacitracin is composed of a group of polypeptides with antibiotic activity against a variety of gram-positive bacteria including staphylococci.
Indication: Used locally for the treatment of infections of the skin, ear, and eye or for intramuscular use in infants for the treatment of pneumonia and empyema caused by susceptible staphylococci in some parts of the world (e.g. Canada).
Application: Administered locally as a combination drug product used in powders, ointments, and solutions. Bacitracin is also administered systemically as intramuscular injections in some parts of the world (e.g. Canada).
Product sheet
Safety data sheet
Product grades
Sterile, micronized
Non-sterile, micronized
Non-sterile, non-micronized
Packaging sizes
Sterile, micronized
750 g
2 kg
Non-sterile, micronized
1 kg
5 kg
15 kg
Non-sterile, non-micronized
1 kg
5 kg
15 kg
Packaging material
Sterile, micronized
Primary: Aluminum container with reinforced butyl lid and tear-off aluminum seal
Secondary: Polystyrene
Non-sterile, micronized
Primary: Polyethylene bag closed with cable tie
Secondary: Heat sealed multi-layer laminated aluminum bag
Non-sterile, non-micronized
Primary: Polyethylene bag closed with cable tie
Secondary: Heat sealed multi-layer laminated aluminum bag
Shelf life
Sterile, micronized
3 years
Non-sterile, micronized
4 years
Non-sterile, non-micronized
4 years
Storage conditions
Store refrigerated (2-8°C/ 36-46°F)
Compliance
Ph. Eur., USP, JP, CP
Manufacturing site
Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile)
Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterilisation 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 health authorities
Regulatory documentation
EU Drug Master File (DMF)/Certificate of Suitability (CEP)
US Drug Master File (DMF)
China Drug Master File (CDMF for non-sterile grade)
Japan Drug Master File (JDMF for non-sterile grade)
DMF also available in other selected countries outside EU/US/China
Other documentations
Written confirmation for import into EU
Chinese Manufacturing License (Taizhou Site)
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