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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 in some parts of the world (e.g. Canada).

Application: Administered locally as a combination drug product used in powders, ointments and solutions. Bacitracin is also administered systemically as intramuscular injections in some parts of the world (e.g. Canada).

 

Product grades

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

Compliance

Ph. Eur.

USP

JP

CP

Manufacturing site

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

Xellia Pharmaceuticals ApS, Copenhagen, Denmark (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)

US Drug Master File (DMF)

China Drug Master File (CDMF for non-sterile grade)

Japan Drug Master File (JDMF for non-sterile grade)

DMF also available in other selected countries outside EU/US/China

Packaging sizes

Sterile

non-micronized

Non-sterile

micronized & non-micronized

750 g

2 kg

1 kg

5 kg

15 kg

Packaging material

Sterile

non-micronized

Non-sterile

micronized & non-micronized

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

Store refrigerated (2-8°C/ 36-46°F)

Other documentations

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