Rocuronium

Perioperative muscle relaxation is a core supporting condition to ensure the smooth implementation of surgical operations. As a representative variety of non-depolarizing steroidal muscle relaxants, rocuronium bromide competitively binds to the N₂-type acetylcholine receptor on the postsynaptic membrane of motor nerve endings and blocks the conduction of nerve impulses to skeletal muscles. In clinical practice, it is mainly used for tracheal intubation during general anesthesia induction and maintenance of muscle relaxation during surgery, and is also suitable for muscle relaxation management of patients requiring mechanical ventilation in intensive care units. It is one of the non-depolarizing muscle relaxants with the fastest onset speed at present, which can effectively shorten the anesthesia induction time and reduce anesthesia-related risks such as regurgitation and aspiration.

The global market size of rocuronium bromide has exceeded 500 million US dollars, with a compound annual growth rate of around 4.2% in the past three years. The domestic market size is approximately 1.2 billion RMB. Driven by the growth in the number of surgical operations and the standardized construction of anesthesiology departments, the annual growth rate remains above 6%. In terms of the competitive landscape, the original research product still accounts for about 35% of the high-end market share. Domestic leading generic drug enterprises, relying on their advantages in cost and winning bids in centralized procurement, have gradually seized the market of secondary and lower-level medical institutions. At present, the rocuronium bromide preparations of 7 domestic enterprises have passed the consistency evaluation, and the terminal price has dropped by more than 70% after centralized procurement, and the overall market penetration rate continues to rise.

The original research enterprise of rocuronium bromide is Organon (now affiliated to the Merck Group), and the original brand name is "Esmeron". The expiration time of its core compound patent in the United States and Europe is 2012, and the Chinese compound patent also expired in 2012. The main dosage form approved for the original research product is injection, with conventional specifications including 2.5ml:25mg and 5ml:50mg. It has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs*, and is also a reference preparation recognized by the FDA. In terms of domestic API registration, at present, the rocuronium bromide APIs of 11 enterprises including Huahai Pharmaceutical and Xianju Pharmaceutical have obtained A-status registration numbers, and more than 20 rocuronium bromide injections have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of rocuronium bromide impurity reference standards, covering all types of research objects such as process impurities and degradation impurities. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of pharmaceutical enterprises in API R&D, quality research and consistency evaluation.