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Bacitracin zinc

Header Description

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

Manufacturing site

Xellia PharmaceuticalsCo.Ltd, Taizhou, China (non-sterile)

CMO for sterilisation only

Release site

Xellia Pharmaceuticals Co. Ltd, Taizhou, China (non-sterile)

Xellia Pharmaceuticals ApS, Copenhagen, Denmark (sterile)

Site registered

EU GMP issued by Danish Medicines Agency

US FDA

Regulatory documentation

EU Drug Master File (DMF)

Certificate of Suitability (CEP) – non-sterile only

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Sterile

Non-Micronised

Non-sterile

Micronised & Non-Micronised

750 g

1kg

5kg

15kg

Packaging material

Sterile

Non-Micronised

Non-sterile

Micronised & Non-Micronised

Primary: Aluminium container with reinforced butyl lid and tear-off aluminium seal

Secondary: Polystyrene

Primary: Polyethylene bag closed with cable tie

Secondary: Heat sealed multi-layer laminated aluminium bag

Shelf life

Non-sterile: 5 years non-sterle

Sterile: EU (36 months), US (48 months)

Storage conditions

Below 25°C (77°F)

Other documentations

Written confirmation for import into EU Chinese Manufacturing License (Taizhou site)