Nicergoline

As a commonly used clinical drug for improving cerebral circulation and cerebral metabolic disorders, nicergoline is a semi-synthetic ergot alkaloid derivative. It can dilate blood vessels by blocking α receptors, while inhibiting phosphodiesterase activity, increasing the levels of ATP and adenosine in brain cells, effectively promoting the conversion of the neurotransmitter dopamine, enhancing cerebral protein synthesis, and improving brain function. Clinically, it is mainly used to improve hypobulia and affective disorders caused by sequelae of cerebral infarction, as well as acute and chronic peripheral circulatory disorders. It is also applicable to the early treatment of vascular dementia, and has clear intervention value especially for elderly patients with cognitive and memory decline.

At present, the global market size of nicergoline is stable at around USD 1.2 billion. Against the background of the rising prevalence of central nervous system diseases, the compound annual growth rate has maintained at 4.2% in the past three years. Domestic generic drugs have occupied nearly 85% of the market share, and the number of preparation enterprises that have passed the consistency evaluation has reached 17. In the fifth batch of national centralized drug procurement, the average price reduction of 68% has achieved a rapid increase in the penetration rate of the primary market. The production capacity of upstream API is mainly concentrated in the East China and Southwest China regions of China. With the global expiration of the patent of the original research compound, the demand of downstream preparation manufacturers for compliant API and supporting impurity research continues to grow.

CATO can provide a full set of impurity reference standards for nicergoline API. All products meet the compliance requirements of regulations of multiple countries including the Chinese Pharmacopoeia and FDA. Core products are in sufficient stock, which can directly support the full-process demands of API registration and declaration, quality research and routine release testing.