Oxybuprocaine

In the clinical practice of local anesthesia in ophthalmology and otorhinolaryngology, the safety and onset speed of surface anesthesia directly affect the diagnosis and treatment experience and operation efficiency. As an ester local anesthetic, oxybuprocaine reversibly blocks the sodium channel of nerve cell membrane and inhibits the generation and conduction of nerve impulses. Its anesthetic intensity is 16 times that of procaine, with strong mucosal permeability and low irritation. Clinically, it is mainly used for surface anesthesia in ophthalmic surgeries (such as phacoemulsification of cataract, excimer laser keratectomy), anesthesia for minor otorhinolaryngological procedures, and local anesthesia for outpatient examinations such as intraocular pressure measurement and corneal foreign body removal. Its applicable population covers adults and pediatric patients following medical advice, avoiding the risk of tissue injury caused by infiltration anesthesia.

At present, the market size of domestic surface anesthesia API has exceeded 1.2 billion yuan, with an annual compound growth rate of about 8.2%, among which ophthalmic local anesthetics account for more than 45%. Oxybuprocaine is the mainstream choice for ophthalmic surface anesthesia due to its high clinical compliance. Imported APIs once accounted for nearly 60% of the domestic market for a long time. With the technological breakthroughs of local enterprises in recent years, the localization rate is increasing year by year. Driven by the centralized procurement policy, the price reduction of downstream preparations has further leveraged the growth of clinical demand for APIs.

The original research enterprise of oxybuprocaine is Santen Pharmaceutical of Japan, and the original research brand name is "Benoxil". Its core compound patent expired in Japan, Europe and the United States in 2009, and the relevant patent in China also expired in 2011. The main dosage form approved by the original research is 0.4% oxybuprocaine hydrochloride eye drops, with specifications including 5ml:20mg and 20ml:80mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and also included in the FDA Reference Preparation Catalogue. At present, 3 domestic enterprises have obtained CDE registration for oxybuprocaine hydrochloride API with the status of A, and more than 10 oxybuprocaine hydrochloride eye drop products have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for oxybuprocaine 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 such as Chinese Pharmacopoeia and FDA, and can help R&D and manufacturing enterprises efficiently complete impurity research, quality standard establishment and other related work, fully meeting the R&D and production quality control needs at different stages.