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 typically as combination drug product used in topical creams, 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 PharmaceuticalsCo.Ltd, Taizhou, China (non-sterile) CMO for sterilisation only |
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Release site |
Xellia Pharmaceuticals Co. Ltd, Taizhou, China (non-sterile) Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterile) |
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Site registered |
EU GMP issued by Danish Medicines Agency US FDA |
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Regulatory documentation |
EU Drug Master File (DMF) Certificate of Suitability (CEP) – non-sterile only US Drug Master File (DMF) Letter of Access (LoA) |
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