Fentanyl

Opioid analgesics are the core clinical option for the management of moderate to severe pain. Among them, fentanyl, a synthetic potent μ-opioid receptor agonist, has an analgesic potency 50 to 100 times that of morphine. It has a fast onset and short duration of action, which can effectively avoid adverse reactions caused by long-acting opioids such as postoperative respiratory depression. At present, this drug is widely used in surgical anesthesia and analgesia, cancer pain control, and stepwise treatment of chronic severe pain, covering the pain management needs of multiple departments such as surgery, anesthesiology, and oncology, and is an indispensable basic drug in the global clinical analgesia system.

The global market size of fentanyl preparations has maintained steady growth in recent years, exceeding USD 6 billion in 2023, with the surgical anesthesia scenario contributing over 60% of the market share. In terms of the domestic market, with the annual increase in surgical volume and the promotion of standardized diagnosis and treatment of cancer pain, the market size of fentanyl-related preparations exceeded RMB 3 billion in 2023, with a compound annual growth rate of around 7%. As fentanyl is a specially controlled narcotic drug, the competitive landscape of the domestic market is highly concentrated, with fewer than 10 approved manufacturers, and the localization rate has exceeded 90%. After the implementation of the centralized procurement policy, the price of relevant preparations has dropped by more than 40%, and patient accessibility has been greatly improved.

The original developer of fentanyl is Janssen Pharmaceutica N.V. of Belgium, with the original brand name Sublimaze, and the core compound patent expired globally in 1981. The current mainstream dosage forms include injection, transdermal patch, sublingual tablet, etc. The conventional specification of the injection is 2ml:0.1mg, and transdermal patches cover multiple dosage specifications such as 25μg/h and 50μg/h. The original injection and transdermal patch have been included in the FDA Reference Listed Drug Catalog, and multiple fentanyl preparations of different specifications in China have also been included in the *Catalog of Reference Preparations for Generic Chemical Drugs*. According to the domestic API registration platform, 8 enterprises have obtained A status for their fentanyl APIs through CDE registration, which can be used for associated review, and more than 20 fentanyl preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for fentanyl API. The products cover the whole research chain including synthetic starting materials, intermediates, and degradation impurities, and meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the various R&D and production needs of pharmaceutical enterprises such as quality research and consistency evaluation.