Our products / APIs
Polymyxin B sulfate
Polymyxin B sulfate is a mixture of sulfates of polypeptide antibiotics active against Pseudomonas aeruginosa and other gram-negative bacteria except the Proteus group.
Indication: Used in the treatment of acute urinary, meningeal, or blood stream infections due to Pseudomonas aeruginosa and other gram-negative pathogens causing serious infections when less potentially toxic drugs are ineffective or contraindicated. It is often used as a combination drug product for the local treatment of skin, ear, eye, and vaginal infections.
Application: Administered systemically as intravenous infusions, intramuscular or intrathecal injections, and locally as eye drops, ear drops, intravaginal capsules, or subconjunctival injections.
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Product grades
Sterile, micronized
Sterile, non-micronized
Non-sterile, micronized
Non-sterile, non-micronized
Packaging sizes
Sterile, micronized
5 BOU (Billion Of Units)
10 BOU (Billion Of Units)
Sterile, non-micronized
10 BOU (Billion Of Units)
Non-sterile, micronized
5 BOU (Billion Of Units)
10 BOU (Billion Of Units)
25 BOU (Billion Of Units)
Non-sterile, non-micronized
10 BOU (Billion Of Units)
Packaging material
Primary: Aluminum containers with PE insert and polypropylene lid
Secondary: Polystyrene
Shelf life
Sterile for US only: 24 months
Sterile (except US) and Non-sterile: 5 years
Storage conditions
Do not store above 25 °C (77 °F)
Compliance
Ph. Eur., USP, CP
Manufacturing site
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
Release site
Xellia Pharmaceuticals ApS, Copenhagen, Denmark
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)
Japan Drug Master File (JDMF)
DMF also available in other selected countries outside EU/US/China/Japan
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