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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.

Application: Administered typically as a combination drug product used in topical creams, powders, ointments and solutions. Bacitracin is also administered systemically as intramuscular injections.

 

Product grades

Sterile, non-micronized Non-sterile, micronized Non-sterile, non-micronized

Compliance

Ph. Eur.

USP

Manufacturing site

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

Xellia Pharmaceuticals ApS, Copenhagen, Denmark (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)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

Sterile

Non-Micronised

Non-sterile

Micronised & Non-Micronised

750 g

2 kg

1 kg

5 kg

15 kg

Packaging material

Sterile

Non-Micronised

Non-sterile

Micronised & Non-Micronised

Primary: Aluminum container with reinforced butyl lid and tear-off aluminum seal

Secondary: Polystyrene

Primary: Polyethylene bag closed with cable tie

Secondary: Heat sealed multi-layer laminated aluminum bag

Shelf life

Non-sterile: 4 years

Sterile: 3 years

Storage conditions

Below 8°C (46°F)

Other documentations

Written confirmation for import into EU. Chinese Manufacturing License