Citicoline

After central nervous system injury, the disorder of phospholipid metabolism in neuronal cell membrane is one of the core pathological links leading to neurological deficit. As an endogenous nucleoside derivative neuroprotective agent, citicoline can promote the synthesis of phosphatidylcholine, stabilize cell membrane structure, reduce free radical production and excitatory amino acid release, and improve cerebral circulation and neural metabolism through multiple mechanisms. This drug is widely used clinically for consciousness disorders caused by acute craniocerebral trauma and brain surgery, and can also be used to improve neurological deficits in the recovery period of stroke. Meanwhile, it has clear evidence-based support for the adjuvant treatment of Parkinson's disease and Alzheimer's disease, and the applicable population covers patients with trauma, cerebrovascular diseases and neurodegenerative diseases.

As a commonly used mature neurological drug in clinical practice, the domestic market size of citicoline has exceeded 2 billion yuan, with an average annual compound growth rate of about 7% in the past three years. The demand expansion in primary medical institutions and rehabilitation scenarios is the main growth driver. At present, the domestic preparation market is dominated by generic drugs, with more than 30 enterprises having passed the consistency evaluation. After centralized procurement, the product price has dropped by more than 80%. The upstream API supply has achieved domestic substitution, and the production capacity of domestic enterprises accounts for more than 65% of the global total production capacity, with significant cost advantages.

The original research enterprise of citicoline is Takeda Pharmaceutical Company Limited of Japan, with the original brand name "Nicholin", and the core compound patent has expired globally before 1990. The main dosage forms approved for the original drug include injection (2ml:250mg) and tablet (0.1g), among which citicoline sodium for injection and tablets have been included in the China Listed Drug Catalogue as reference preparations. At present, more than 40 domestic enterprises have obtained Class A status for their citicoline APIs through CDE registration, and multiple corresponding preparation varieties including tablets, injections, capsules and lyophilized preparations have been approved for marketing, with sufficient supply. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of citicoline impurity reference standards, which fully meet the declaration requirements of pharmacopoeias of various countries. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. The products fully comply with the compliance standards of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and provide stable and reliable reference standard support for the R&D, production and quality control links of APIs.