Remifentanil

As a highly selective μ-receptor agonist in the field of opioid analgesics, remifentanil has become a core medication for perioperative analgesia due to its unique pharmacological properties: metabolism independent of liver and kidney functions, rapid onset, quick elimination and no accumulation. It inhibits pain signal transduction by activating opioid receptors in the central nervous system, and is indicated for general anesthesia induction, intraoperative analgesia maintenance, and continuous analgesia for intensive care patients. It is particularly suitable for anesthesia management of special populations such as the elderly and patients with hepatic and renal insufficiency, and can significantly reduce the risk of adverse reactions such as postoperative respiratory depression and delayed awakening.

At present, the global market size of remifentanil has exceeded 1.2 billion US dollars, with a compound annual growth rate of 6.8% in the past three years. The growth is mainly driven by the increase in the volume of day surgery and the release of demand for comfortable medical care. The Chinese market accounts for approximately 26% of the global market, with the annual consumption in public medical institutions exceeding 4.5 million vials. The competitive landscape features the coexistence of the originator drug and generic drugs, with the top 3 generic drug manufacturers occupying nearly 60% of the domestic market share. After the centralized procurement, the terminal price has dropped by more than 70%, which further promotes the improvement of clinical accessibility.

The originator of remifentanil is GlaxoSmithKline, with the original brand name "Rui Jie". The core compound patent expired in China as early as 2017, and the core formulation patent in the US market expired in 2018. The main formulation approved for the originator drug is powder for injection, with common specifications of 1 mg and 2 mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also a reference preparation designated by the FDA. Up to now, there are 11 registration entries of remifentanil active pharmaceutical ingredients (APIs) on the API registration platform of China's Center for Drug Evaluation (CDE), among which 8 have obtained Class A status after joint evaluation with formulations. There are 17 marketed remifentanil formulation products approved in China, covering two dosage forms: powder for injection and lyophilized powder for injection. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of remifentanil impurity reference standards, covering all types of impurities involved in the synthesis process and degradation pathways. The vast majority of products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support the usage requirements in different scenarios such as API registration and declaration, quality research and routine quality control.