Benzocaine

As a commonly used local anesthetic in clinical practice, benzocaine belongs to the aminobenzoate class of local anesthetics. It exerts local analgesic and antipruritic effects by reversibly inhibiting sodium channels on nerve cell membranes and blocking the generation and conduction of nerve impulses. Clinically, it is mostly used to relieve pain and itching caused by skin and mucosal wounds, ulcers and hemorrhoids. It can also be used as a surface anesthetic for throat and ear canal examinations, and is added to some topical delay preparations to improve symptoms of premature ejaculation in men. Its applicable population covers a wide range from patients with common skin injuries to people receiving specialized diagnosis and treatment.

At present, the global benzocaine market size maintains steady growth. In 2023, the market size was approximately USD 230 million, with a compound annual growth rate of around 3.8%. In terms of the domestic market, due to the continuous increase in demand in the daily chemical and topical preparation fields, the domestic demand for benzocaine API was approximately 1,200 tons in 2023. Local enterprises are the main force of market supply, and the production capacity of domestic manufacturers accounts for more than 65% of the global total production capacity. The products of leading enterprises have passed FDA and CEP certifications, and are mainly exported to Europe, America, Southeast Asia and other markets. The implementation of centralized procurement-related topical preparations has further driven the procurement demand for APIs.

The original research enterprise of benzocaine is Merck Group, Germany, and the original research brand name is Anaesthesin. Its core compound patent expired in the early 20th century, and there is currently no core patent restriction. The mainstream dosage forms include 5% and 10% topical ointments, 20% aerosols and buccal tablets. The original research product has been included in the FDA Reference Listed Drug Catalog. In terms of domestic API registration, more than 30 enterprises have obtained CDE registration numbers for benzocaine APIs, most of which are in status A and can be used in association with domestic preparation declarations. The number of domestically approved benzocaine-related preparations has exceeded 50 specifications, covering multiple dosage forms such as ointments, gels and buccal tablets. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of benzocaine impurity reference standards, which can meet the requirements for qualitative and quantitative analysis of impurities under different synthesis processes. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support various stages of work including API R&D, quality research and consistency evaluation.