Our products / APIs
Bacitracin zinc
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.
Indication: Used in the treatment of local infections, mainly infections of the skin, ear, and eye.
Application: Administered locally as a combination drug product used in powders, ointments, and solutions.
Product sheet
Safety data sheet
Product grades
Sterile, micronized
Non-sterile, micronized
Non-sterile, non-micronized
Packaging sizes
Sterile, micornized
750 g
Non-sterile, micronized
1kg
5kg
15kg
Non-sterile, non-micronized
1kg
5kg
15kg
Packing 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
Ph. Eur. (36 months)
USP (48 months)
Non-sterile, micronized
5 years
Non-sterile, non-micronized
5 years
Storage conditions
Do not store above 25 °C (77 °F)
Compliance
Ph. Eur., USP
Manufacturing site
Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile)
CMO for 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) - non-sterile only
US Drug Master File (DMF)
DMF also available in other selected countries outside EU/US
Other documentations
Written confirmation for import into EU
Chinese Manufacturing License (Taizhou Site)
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