Tetracaine

As a commonly used local anesthetic in clinical practice, tetracaine belongs to the category of ester local anesthetics. It exerts anesthetic effects by reversibly blocking sodium channels on nerve cell membranes and inhibiting nerve impulse conduction. It has high liposolubility and strong mucosal penetration ability, with an anesthetic potency 10 times that of procaine, and its duration of action can reach 2-3 hours. Clinically, it is mainly used for surface anesthesia, conduction block anesthesia, epidural anesthesia and subarachnoid anesthesia, and can also be used for local analgesia in outpatient procedures in ophthalmology, otorhinolaryngology, stomatology and other departments. The applicable population covers patients of all age groups who need to receive local anesthesia procedures. The dosage should be strictly controlled during use to avoid toxic and adverse reactions.

The global tetracaine market size maintains an overall steady growth trend. In 2023, the market size was approximately USD 280 million, with a compound annual growth rate maintained at around 3.2%. In the domestic market, tetracaine is a mature anesthetic drug, with stable demand from primary medical institutions and specialized surgeries. It has been included in the centralized procurement catalogs of multiple provinces at present, with an average decrease of 46% in the winning bid price compared to the highest online listing price. The market pattern is dominated by domestic generic drugs, and domestic API manufacturers are mainly concentrated in Jiangsu, Hubei and other regions, with sufficient overall supply.

The original research enterprise of tetracaine is Sandoz GmbH, with the original research brand name Pontocaine, and its core compound patent expired globally in the 1970s. The original research dosage forms include injections, eye drops, topical ointments, etc. Among them, 1% tetracaine hydrochloride injection and 0.5% tetracaine hydrochloride eye drops are the main commonly used specifications, and the relevant original research dosage forms have been included in the FDA Reference Listed Drug Catalog. Up to now, there are 12 tetracaine API registration entries on the domestic CDE API registration platform, 7 of which have been activated in Status A and can be used for associated preparation declaration. Multiple preparation varieties such as tetracaine hydrochloride injection and tetracaine hydrochloride gel have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for tetracaine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can meet the reference standard use needs of the whole process including API R&D, quality research, registration and declaration, providing reliable support for quality control in the R&D and production links of enterprises.