Neuroxon now included into State Pharmacopoeia of Ukraine
In July, four new monographs – on active ingredient Citicoline Sodium and its dosage forms (solution for injection, oral solution and tablets) – were added into the State Pharmacopoeia of Ukraine. The substance is used in Arterium’s drug Neuroxon. According to Sergey Sur, a Regulatory Affairs Director at Arterium Corporation, a lot of other Citicoline Sodium-based drugs were registered in Ukraine, but there have been no unified requirements for their quality in Ukraine’s Pharmacopoeia until now. The mentioned monographs set new, more rigid criteria for registration and quality control of all Citicoline Sodium-containing medicinal products in Ukraine. Besides, their inclusion into the State Pharmacopoeia of Ukraine has brought the requirements for the quality of the active ingredient and finished medicinal products for all products in the Ukrainian market to the level of Arterium’s Neuroxon. Arterium Corporation initiated development of the monographs back in 2015. The main difficulty was that the requirements set by the Pharmacopoeia needed to take into account all possible synthesis schemes for the substance, providing unified quality parameters across all products. On the public debate stage, it took a lot of effort to secure approval of draft monographs by other producers of similar drugs.