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 grades |
Sterile, micronized Non-sterile, micronized Non-sterile, non-micronized | |||||
Compliance |
Ph. Eur. USP |
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Manufacturing site |
Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) CMO for sterilisation only |
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Release site |
Xellia (Taizhou) Pharmaceuticals Co., Ltd., China (non-sterile) Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterile) |
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Site registered |
EU GMP issued by Danish Medicines Agency US FDA Other health authorities |
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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 |
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Packaging material |
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