Reserpine

Hypertension is one of the chronic diseases with the highest prevalence in the world, and rapid blood pressure reduction for severe hypertension and hypertensive crisis has always been an unmet clinical need. Reserpine is an anti-hypertensive drug of the sympathetic nerve inhibitor class. It depletes neurotransmitters such as norepinephrine and epinephrine in peripheral sympathetic nerve endings and blocks the conduction of sympathetic nerve impulses, thereby dilating peripheral blood vessels and reducing peripheral resistance to achieve a stable blood pressure lowering effect. Clinically, it is mainly used for the treatment of moderate to severe hypertension, especially suitable for hypertensive patients with mental tension and fast heart rate, and it still has irreplaceable clinical value in the management of hypertensive emergencies.

The global reserpine market size is approximately USD 180 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 2.7%. Due to the early launch time and mature clinical application of this drug, the market is dominated by generic drug supply, and leading manufacturers are concentrated in regions with advantages in API production capacity such as India and China. China is the world's largest exporter of reserpine API, supplying more than 60% of the total global demand. The localization rate of APIs for preparations winning the centralized procurement bid has reached 100%, and the overall market supply is stable with small price fluctuations.

The original developer of reserpine is Novartis, with the original brand name Serpasil. The core compound patent expired globally in 1959. The originally launched dosage forms include tablets and injections, among which the tablet specifications are 0.1mg and 0.25mg, and the injection specification is 1mg/1mL. They have been included in the FDA Reference Listed Drug Catalog, and the corresponding dosage forms are also included in the Chinese Catalog of Reference Preparations for Chemical Drugs. Up to now, 12 Chinese enterprises have obtained CDE registration (status A) for their reserpine APIs. Domestically approved reserpine preparations include conventional tablets, compound reserpine tablets and injections, with more than 200 cumulative approval documents. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of reserpine impurity reference standards, covering the full-path research needs such as synthesis process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the full-process use needs such as API registration and declaration, quality research, and ex-factory inspection.