Naftidrofuryl

Peripheral vascular disease, a chronic disease with high incidence among middle-aged and elderly people, is often accompanied by symptoms such as limb ischemia, pain and even intermittent claudication, which seriously affects the quality of life of patients. Naftidrofuryl, as a class of selective vasodilators, inhibits vasoconstriction and platelet aggregation mediated by 5-hydroxytryptamine receptors, improves erythrocyte flexibility and reduces blood viscosity at the same time, and increases the blood flow of peripheral vessels and cerebral vessels without affecting systemic blood pressure. It is mainly used clinically to treat peripheral arterial occlusive disease, Raynaud's syndrome and sequelae of ischemic cerebrovascular disease, and is a classic peripheral circulation improving drug with both efficacy and safety.

At present, the global market size of naftidrofuryl preparations is about USD 230 million, and the compound growth rate in the past three years has remained at 4.1%. The growth momentum mainly comes from the rising prevalence of peripheral vascular disease in the elderly population and the release of demand for long-term chronic disease medication in the primary market. In terms of the domestic market, naftidrofuryl oral preparations have been included in the local medical insurance catalogs of many provinces, with an overall market size of about RMB 180 million. There are less than 5 approved preparation manufacturers, the competition pattern of generic drugs is relatively relaxed, and there is still room to fill the gap in supporting supply of active pharmaceutical ingredients.

The original research enterprise of naftidrofuryl is Laboratory Laphal, a French company, with the original research trade name "Clarantin". Its core compound patent expired worldwide in 2002. The main dosage form of the original research product is naftidrofuryl oxalate capsule, with a specification of 100 mg per capsule. This original research dosage form has been included in the reference preparation catalog of the European Medicines Agency (EMA), and has not yet been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration (NMPA) of China. As of the retrieval time, no valid registration number (A status) of naftidrofuryl has been found on the API registration platform of the Center for Drug Evaluation (CDE) of China. There are only 3 domestic approved marketing authorization numbers for naftidrofuryl oxalate oral preparations, and the supply of active pharmaceutical ingredients currently mainly relies on import channels. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for naftidrofuryl, covering the full spectrum of reference substances such as intermediates in the synthesis process and degradation impurities. Most products have sufficient in-stock inventory. In-stock products ordered before 16:00 can be shipped on the same day. All reference standards meet the requirements of pharmacopoeias of multiple countries such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of the whole process of API research and development, quality research and registration declaration.