There are more than 30 million imaging procedures are performed each year in the US. And iodinated contrast agents represent more than 60% of all X-ray imaging agents sold with an annual US market of approximately $1.5 billion. (1)
The global key manufacturers of iohexol API include GE Healthcare, Otsuka Chemicals, and Starry Pharma. Global top three manufacturers hold a share about 85%, while in US, there is NO generic product. (as of 01/11/2024)
FORMULATION, MANUFACTURING AND PACKAGING
OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL.
A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL.
Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives.
API SUPPLIERS
Zhejiang Starry Pharmaceutical Co. Ltd.
Hovione Farmaciencia
Interpharma Praha AS (Oral product)
Divi’s Labotatories Ltd.
API SYNTHESIS
Crude iohexol is obtained from the reaction between 5-Acetamide and 1-chloro-2,3- propandiol at ambient temperature in propylene glycoi and in the presence of sodium methoxide.
Related patents are expiring. EP 1641743B1, GE Healthcare AS Filing YR 2004. 6153796, Nycomed Imaging AS (Oslo) Filing YR 2000.\
REFERENCE
