Nefopam

Perioperative analgesia and chronic pain management are important areas of clinical medication. Non-opioid analgesics have the advantage of no addiction risk, so their clinical demand has been rising continuously in recent years. Nefopam is a central non-narcotic analgesic, which exerts analgesic effect by inhibiting the reuptake of neurotransmitters such as 5-hydroxytryptamine and norepinephrine in the central nervous system, and blocking sodium and calcium ion channels at the same time. Its analgesic intensity is about 10 times that of aspirin, and it has no respiratory depression, no addiction and no tolerance risk. Clinically, it is mainly used for postoperative pain, cancer pain, acute traumatic pain, and also for visceral smooth muscle colic caused by acute gastritis, biliary ascariasis, ureteral calculi, etc. The applicable population covers patients of all ages who need moderate to severe analgesia but need to avoid the adverse reactions of opioids. The medication restrictions for special populations are far less than those of conventional opioid analgesics.

The global nefopam market size has maintained a compound annual growth rate of 3.2% in recent years, and the overall market size in 2023 was approximately USD 180 million, of which generic drugs accounted for more than 92%. In terms of the domestic market, nefopam preparations have been included in the Class B medical insurance catalogs of many provinces. In 2023, the domestic terminal sales were approximately RMB 230 million, and local enterprises accounted for more than 98% of the market share. At present, more than 20 enterprises have been approved to produce oral and injectable dosage forms of nefopam, and the supply of API has basically been localized.

The original manufacturer of nefopam is Pierre Fabre Medicament of France, with the original brand name Nefopam, and the core compound patent expired globally in 1987. The main dosage forms of the original product that have been marketed are 20mg tablets and 20mg/1ml injections, both of which have been included in the reference preparation catalogs of the EU EMA and FDA. In terms of domestic API registration, at present, 6 domestic enterprises' nefopam APIs have obtained the review and approval publicity of CDE (status A). The domestically approved nefopam preparations include three major categories: nefopam hydrochloride tablets, nefopam hydrochloride injection and nefopam hydrochloride sustained-release tablets, covering commonly used clinical dosage forms. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for nefopam API, covering all starting materials, intermediates, degradation impurities and corresponding isotope internal standards in the synthesis route. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia, FDA and ICH. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can fully meet the needs of impurity reference standards in different scenarios such as API R&D, quality research and consistency evaluation.