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Our products / APIs

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 sheet

Safety data sheet

Product grades

Sterile, micronized

Non-sterile, micronized

Non-sterile, non-micronized

Packaging sizes

Sterile, micronized

750 g
2 kg

Non-sterile, micronized

1 kg
5 kg
15 kg

Non-sterile, non-micronized

1 kg
5 kg
15 kg

Packaging material

Sterile, micronized

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

Secondary: Polystyrene

Non-sterile, micronized

Primary: Polyethylene bag closed with cable tie

Secondary: Heat sealed multi-layer laminated aluminum bag

Non-sterile, non-micronized

Primary: Polyethylene bag closed with cable tie

Secondary: Heat sealed multi-layer laminated aluminum bag

Shelf life

Sterile, micronized

3 years

Non-sterile, micronized

4 years

Non-sterile, non-micronized

4 years

Storage conditions

Store refrigerated (2-8°C/ 36-46°F)

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

Other documentations

Written confirmation for import into EU

Chinese Manufacturing License (Taizhou Site)

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