Atracurium

Perioperative muscle relaxation is an important support for the smooth implementation of surgical operations. Non-depolarizing muscle relaxants, with the advantages of strong controllability and few adverse reactions, have become the core choice for clinical muscle relaxation management. Atracurium is a benzylisoquinoline type non-depolarizing muscle relaxant. It competitively binds to acetylcholine receptors on the postsynaptic membrane of motor nerve endings and blocks the conduction of nerve impulses to skeletal muscles, thereby producing a reversible muscle relaxation effect. Its clinical advantage lies in that its metabolism does not depend on liver and kidney functions, and it can be self-degraded through Hofmann elimination. It is especially suitable for patients with hepatic and renal insufficiency, elderly patients and critically ill surgical patients, and is routinely used for general anesthesia induction for tracheal intubation, intraoperative muscle relaxation maintenance, and adjuvant therapy for mechanical ventilation in intensive care units.

According to publicly verifiable data, the market size of muscle relaxants at the terminals of Chinese public medical institutions exceeded 7 billion yuan in 2023. Among them, atracurium and cisatracurium together accounted for nearly 60%, making them core varieties in the muscle relaxant field. In recent years, with the continuous growth of the number of minimally invasive surgeries, the annual compound market growth rate of atracurium has remained at around 8%. At present, generic drugs dominate the domestic market, and more than 20 enterprises have obtained the production qualification for atracurium preparations. After the implementation of centralized procurement, the price of this variety has dropped by more than 70%, and its clinical accessibility has been greatly improved, which has also driven the sustained and stable growth of the demand for upstream APIs.

The original research enterprise of atracurium is GlaxoSmithKline, and the original research trade name is Tracrium. Its core compound patent first expired globally in 1996. The main dosage form of the original research product launched is injection, and the conventional specifications include 2.5ml:25mg and 5ml:50mg, which have been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. In terms of domestic API registration, more than 15 enterprises have obtained A status for their atracurium APIs through CDE registration, which can be used for associated review. The number of atracurium injection varieties approved for marketing in China has exceeded 30. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for atracurium, covering all categories of reference standards including process impurities, degradation impurities and enantiomers. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day, which can efficiently meet the full-process needs of API R&D, quality research and routine quality control.

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