Home - Products - Colistin Sulfate

Colistin Sulfate

Colistin Sulfate is a mixture of the sulfates of polypeptide antibiotics active against Gram-negative bacteria.

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

 

Application: Colistin Sulfate is administered orally as suspensions or tablets for treatment of intestinal infections. It can also be used for treatment of ear infections.

 

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

Secondary: Polystyrene

Shelf life

18 months (according to Ph. Eur.)

5 years (according to USP)

Storage conditions

Below 25°C (77°F)

* BOU = Billions of units.