Epinephrine /Adrenaline

The rescue of acute and critical illnesses such as allergic reactions and cardiac arrest has always been the core demand of clinical diagnosis and treatment. As an α and β adrenoceptor agonist, epinephrine is the first-choice drug in such first-aid scenarios. Its mechanism of action includes activating the β2 receptor of bronchial smooth muscle to relieve spasm, inhibiting mast cells from releasing allergic mediators, activating α receptors to constrict peripheral blood vessels and raise blood pressure, and acting on the cardiac β1 receptor to enhance myocardial contractility. It is not only used for the first aid of anaphylactic shock and cardiac arrest, but also can be combined with local anesthetics to prolong the administration time and reduce local bleeding. It is an essential variety in the first-aid kits of medical institutions at all levels, covering first-aid populations of all age groups.

As a clinically rigidly demanded first-aid API, the global market size of epinephrine is stable at around USD 320 million, with an annual compound growth rate maintained at 4.8%. On the demand side, it maintains rigid growth driven by the improvement of the emergency system and the construction of primary first-aid capabilities. The competitive landscape is characterized by concentration, with leading manufacturers accounting for more than 65% of the total production capacity. In the domestic market, local enterprises account for more than 80% of the supply, import substitution has been completed, and China is also one of the major exporters of this variety. In 2023, the export volume increased by 12% year-on-year, mainly supplying emerging markets such as Southeast Asia and Latin America.

The original research enterprise of epinephrine is Steris in the United States, and the original research trade name is Adrenalin. The core U.S. compound patent expired in 1986. At present, the mainstream marketed dosage forms include injection (1ml:1mg, 0.5ml:0.5mg), auto-injector (0.3mg/0.15mg) and inhalation solution. The injection dosage form has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Listed Drugs of Chemical Drugs* of China. At present, 8 domestic enterprises have obtained A status for their epinephrine APIs through CDE registration, which can be directly associated with preparation declaration, and more than 20 domestic approval documents for epinephrine injection have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for epinephrine 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 standard support for enterprises in the links of API R&D, quality research and registration declaration.