Nimodipine

Cerebral vasospasm is a common complication after subarachnoid hemorrhage, which is prone to induce secondary cerebral ischemic injury, and its disability and mortality rates have remained high for a long time. Nimodipine is a second-generation dihydropyridine calcium channel blocker, which can specifically block the calcium influx channels on the cell membrane of cerebral vascular smooth muscle, relieve the state of vasospasm, and improve cerebral microcirculation without producing the "steal phenomenon". It is currently the first-line drug for the prevention and treatment of cerebral vasospasm after subarachnoid hemorrhage, and can also be used for ischemic neuron protection, adjuvant therapy of senile brain dysfunction and migraine. Its applicable population covers patients with cerebrovascular diseases and some elderly groups with cognitive function decline.

The global nimodipine market size is stable at around USD 1.2 billion, and the Chinese market size is approximately RMB 1.8 billion, with a compound annual growth rate maintained at 3.2%. Due to the early launch time of this drug, its patent protection has fully expired, and the market is dominated by generic drugs. There are more than 70 domestic preparation manufacturers, among which the price of oral dosage forms winning the bid in centralized procurement has dropped by more than 80%, and the clinical accessibility has been greatly improved. On the API supply side, the production capacity of domestic enterprises accounts for more than 65% of the total global supply, and China is the core exporter of nimodipine API.

The original research enterprise of nimodipine is Bayer HealthCare, and the original brand name is Nimotop®. The core compound patent was first approved in Europe in 1980, and the Chinese compound patent expired in 2001. At present, the dosage forms of the original research drug approved in China include tablets (30mg), injection (50ml:10mg) and soft capsules (20mg), among which the 30mg tablets and 10mg injection have been included in the Chinese Listed Medicines Catalogue as reference preparations, and are also included in the FDA Reference Preparations List. Up to now, there are 32 registration entries of nimodipine API on China CDE API Registration Platform, among which 22 are in the status of "A (approved for use in marketed preparations)". The domestically approved nimodipine preparations cover all dosage forms such as oral regular-release dosage forms, injections and sustained-release capsules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of nimodipine impurity reference standards. The products simultaneously meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most categories are in stock regularly. Spot orders paid before 16:00 can be shipped on the same day, which can fully meet the needs of various R&D scenarios such as impurity research, quality standard establishment and consistency evaluation.