Ephedrine

As a classic sympathomimetic amine drug, ephedrine can directly agonize α and β adrenergic receptors, and also promote the release of norepinephrine from adrenergic nerve terminals to exert an indirect effect. It can relax bronchial smooth muscle, constrict local blood vessels, enhance myocardial contractility, and excite the central nervous system at the same time. Clinically, it is mainly used to prevent the onset of bronchial asthma and relieve mild asthma symptoms. It can also be used to prevent and treat hypotension caused by subarachnoid or epidural anesthesia, and relieve nasal congestion caused by congestion and swelling of the nasal mucosa. It has been applied for a long time in the fields of respiratory medicine, anesthesiology, otorhinolaryngology and other fields.

The global market size of ephedrine API is approximately USD 1.6 billion, with a compound annual growth rate maintained at around 3.8%. Affected by strict regulatory policies, the concentration of the supply side of the market is extremely high. China is the world's most important producer and exporter of ephedrine, with its production capacity accounting for more than 80% of the global total. Affected by the dual influence of centralized procurement and special drug control in the domestic market, the access threshold in the circulation link is high, and the compliance supply capacity is the core consideration for downstream preparation enterprises when selecting suppliers.

As a classic drug with a long application history, ephedrine has no clear single original research enterprise. At present, the ephedrine preparations already on the market in China are mainly compound preparations, including ephedrine nasal drops, compound ephedrine theophylline tablets and other dosage forms, all of which have been included in the medical insurance catalog. As of October 2024, there are 22 valid registration numbers of ephedrine API registered on the platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, among which 17 are in A status and can be used in association with preparations marketed and sold in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of ephedrine impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, they meet the compliance requirements of multiple regulations including Chinese Pharmacopoeia and FDA, and can fully support the reference standard needs of the whole process of API R&D, quality research and routine production.