Papaverine

As a classic non-specific smooth muscle relaxant, papaverine exerts its effects by inhibiting phosphodiesterase and reducing calcium ion influx. It can directly relax various smooth muscle tissues such as blood vessels, gastrointestinal tract and biliary tract. Clinically, it is mainly used to relieve ischemia caused by spasm of cerebral, cardiac and peripheral blood vessels, and can also improve pain caused by visceral spasm of kidney, gallbladder or gastrointestinal tract. It is a commonly used symptomatic treatment drug in emergency department, vascular surgery and gastroenterology department, and its applicable population covers adult patients with spasm symptoms. Dose adjustment should be paid attention to when used in elderly patients.

At present, the global papaverine market size is about 320 million US dollars, and the domestic market size maintains a compound annual growth rate of 12%. The growth momentum mainly comes from the release of diagnosis and treatment demand for vascular diseases in primary medical institutions. In terms of competitive landscape, the domestic preparation market is dominated by generic drugs, and the supply of API is concentrated in a few enterprises with narcotic drug production qualifications. As this variety is a specially controlled drug, the industry access threshold is relatively high, and the supplier concentration is much higher than that of ordinary chemical APIs.

The original research enterprise of papaverine is Mallinckrodt, and the original research trade name is Papaverine Hydrochloride. The core compound patent has expired globally in 1970. The current mainstream dosage forms include papaverine hydrochloride injection (1ml:30mg) and oral tablets (30mg). Among them, the original research injection has been included in the FDA Reference Listed Drug Catalogue, and most of the generic drugs marketed in China take this product as the reference. According to the domestic API registration platform, at present, the papaverine hydrochloride APIs of 3 domestic enterprises have obtained Class A status through CDE registration and can be legally supplied to preparation manufacturers, and the registration applications of another 2 enterprises are under review. (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 papaverine hydrochloride API. Most products can be supplied directly from stock. Stock orders placed before 16:00 can be shipped on the same day. All reference standards comply with the requirements of pharmaceutical regulatory regulations of various countries such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of enterprises from API R&D, quality research to registration and declaration.