Carbamazepine

Abnormal discharge in the central nervous system is the core pathological basis of epileptic seizures. As a classic first-line anti-epileptic drug, carbamazepine belongs to dibenzazepine compounds. It blocks voltage-dependent sodium channels to inhibit high-frequency abnormal discharge of neurons, and meanwhile regulates the γ-aminobutyric acid conduction pathway to exert the effect of stabilizing nerve cell membranes. Its clinical indications cover multiple types of epilepsy such as tonic-clonic seizures and partial seizures. It can also be used for the symptomatic treatment of trigeminal neuralgia and glossopharyngeal neuralgia, as well as the control of manic episodes in bipolar affective disorder. It is applicable to adult epilepsy patients and pediatric epilepsy patients over 4 years old, and is one of the core varieties in the clinical medication system of neurology.

At present, the global carbamazepine market size is stable at around USD 1.2 billion, with a compound annual growth rate maintained at a gentle level of 2.3%, showing a significant characteristic of rigid demand. For the domestic market, the annual sales of oral dosage forms exceed RMB 800 million, among which tablets account for more than 85%. The competition landscape is dominated by generic drugs. There are already more than 300 carbamazepine preparation approvals in China, and the production of core APIs is concentrated in leading characteristic pharmaceutical enterprises in Jiangsu and Zhejiang, with a mature overall supply system. The winning bid price in centralized procurement has dropped by more than 70% compared with the original research product, which has greatly improved the accessibility of medication for patients.

The original research enterprise of carbamazepine is Novartis, and the original research trade name is Tegretol. Its core compound patent expired worldwide in 1968. The main marketed dosage forms of the original research product include oral tablets, sustained-release capsules and suspensions, among which the core specifications of tablets are 100mg and 200mg, and the specifications of sustained-release tablets are 200mg and 400mg. The original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. According to the domestic API registration platform, there are currently more than 20 A-status registration numbers for carbamazepine APIs, which can be supplied for associated preparation review in compliance with regulations. The domestically approved carbamazepine preparations cover multiple dosage forms such as conventional tablets, sustained-release tablets and capsules, meeting the needs of different clinical scenarios. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for carbamazepine API, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable reference substance support for API R&D, quality research and consistency evaluation.