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Colistin sulfate

Colistin sulfate is a mixture of sulfates of polypeptide antibiotics active against Gram-negative bacteria including Pseudomonas aeruginosa, Enterobacter aerogenes, Escherichia coli and Klebsiella pneumoniae.

Indication: Used in the treatment of acute infections due to sensitive strains of Gram-negative pathogens.

Application: Administered topically in the treatment of local infections, mainly external ear infections. Often formulated as otic suspensions and solutions.

Product grades

Non-sterile, non-micronized

Compliance

Ph. Eur.

USP

Manufacturing site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Release site

Xellia Pharmaceuticals ApS, Copenhagen, Denmark

Site registered

EU GMP certificate

US FDA

Other health authorities

Regulatory documentation

EU Drug Master File (DMF)/Certificate of Suitability (CEP)

US Drug Master File (DMF)

Letter of Access (LoA)

Packaging sizes

10 BOU*

150 BOU*

Packaging material

Primary: Aluminum containers with a polyethylene insert and polypropylene lid

Secondary: Polystyrene

Shelf life

Ph. Eur.: 18 months

USP: 60 months

Storage conditions

Below 25°C (77°F)

*Billion Of Units