Lidocaine

As a commonly used amide local anesthetic in clinical practice, lidocaine blocks nerve impulse conduction by inhibiting the influx of neuronal sodium channels, and has both analgesic and antiarrhythmic effects. Its local anesthetic efficacy is 2-3 times that of procaine, with fast onset and strong mucosal penetration. It is widely used for local infiltration anesthesia and nerve block in surgical operations, dental treatment, and endoscopic examination. It can also be administered intravenously to control acute ventricular arrhythmias. Meanwhile, its topical dosage forms can relieve a variety of pain symptoms such as postherpetic neuralgia and oral ulcers, making it an essential basic drug for medical institutions at all levels.

The global lidocaine market size has maintained steady growth all year round. In 2023, the market size reached USD 1.28 billion, with a compound annual growth rate of approximately 4.2%. Since the patents have long expired, the market is mainly supplied by generic drugs. China is the world's core producer of lidocaine API, with production capacity accounting for more than 65% of the global total. The winning bid price in China's centralized procurement has dropped by up to 78% compared with the original research product, which greatly improves the accessibility in primary medical institutions. At present, more than 95% of the lidocaine preparations used clinically are domestic generic drugs.

The original research enterprise of lidocaine is Pfizer, with the original research trade name Xylocaine®. The core compound patent expired globally in 1969. The current mainstream dosage forms include lidocaine hydrochloride injection (5ml:0.1g, 10ml:0.2g), compound lidocaine cream (10g:0.2g) and topical patches. Multiple dosage forms have been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparation Catalogue. Up to now, China CDE API Registration Platform has included 32 valid registration numbers of lidocaine API, among which 24 are in A status. The domestically approved lidocaine preparations on the market cover 11 dosage forms including injection, cream, mucilage, aerosol, etc., with a total of 187 approvals. (Data as of July 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of lidocaine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of drug research and development, quality research and release testing.