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Bioniche Pharma Introduces Ibutilide Fumarate Injection

Bioniche Pharma (Bioniche) has launched Ibutilide Fumarate injection, the generic equivalent of Corvert from Pfizer. Bioniche is expected to supply Ibutilide Fumarate injection in 0.1mg/ml, 10ml vials.

Corvert injection (Ibutilide fumarate injection) is an antiarrhythmic drug with predominantly class III (cardiac action potential prolongation) properties according to the Vaughan Williams Classification. Each milliliter of Corvert injection contains 0.1mg of ibutilide fumarate (equivalent to 0.087mg ibutilide free base), 0.189mg sodium acetate trihydrate, 8.90mg sodium chloride, hydrochloric acid to adjust pH to approximately 4.6, and water for injection.

Corvert injection is an isotonic, clear, colorless, sterile aqueous solution. Ibutilide fumarate has one chiral center, and exists as a racemate of the (+) and (–) enantiomers. Ibutilide fumarate is a white to off-white powder with an aqueous solubility of over 100mg/ml at pH 7 or lower.

George Zorich, president for US operations at Bioniche Pharma, said: “The addition of Ibutilide Fumarate injection further demonstrates Bioniche Pharma’s continued growth and dedication to a consistently expanding portfolio of injectables.”