Articaine

As a commonly used amide local anesthetic in clinical practice, articaine exerts a rapid and long-acting local anesthetic effect by blocking sodium channels on the nerve cell membrane and inhibiting the conduction of nerve impulses. Compared with similar anesthetics, it has strong tissue permeability, short anesthetic onset time, and little impact on the cardiovascular system. At present, it is mainly used for local infiltration anesthesia in dental extraction, pulp treatment, periodontal surgery and other procedures, and can also be used for local anesthesia in some minor surgical operations. It is applicable to adults and children over 4 years old, and is one of the mainstream anesthetics in the field of oral diagnosis and treatment.

At present, the global local anesthetic market size has exceeded 8 billion US dollars, of which oral local anesthetics account for nearly 35%, and the compound annual growth rate is maintained at around 4.2%. With its clinical advantages, articaine accounts for nearly 40% of the oral local anesthetic market. In the domestic market, the original research product still occupies a dominant position, and the number of approved generic drugs is small. With the continuous rise of domestic demand for oral diagnosis and treatment services, the annual growth rate of market demand for articaine is stable at more than 6%, and the gradual promotion of the centralized procurement policy also provides a broad market space for generic drugs and supporting API suppliers.

The original research enterprise of articaine is Sanofi, France, and the original trade name is "Primacaine". Its core compound patent expired in the European and US markets in 2007, and the compound patent in China expired in 2006. The main dosage form approved for the original research product is articaine hydrochloride injection, with the common specifications of 1.7ml: 68mg articaine hydrochloride and 17μg epinephrine. This product has been included in the *Catalogue of Chemical Reference Preparations* of China, and also included in the FDA Reference Preparation Catalogue. Up to now, the articaine hydrochloride APIs of a number of domestic enterprises have obtained Class A status through CDE registration, and a number of domestic articaine hydrochloride injection varieties have been approved for marketing. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for articaine, which strictly comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most of the products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the sample needs of API R&D, quality research, consistency evaluation and other scenarios.