Ropinirole

As a common degenerative disease of the central nervous system, Parkinson's disease has a prevalence rate of 1.7% among people over 65 years old. Patients' quality of life is often severely affected by symptoms such as bradykinesia and resting tremor. Ropinirole is a second-generation non-ergot dopamine receptor agonist, which can highly selectively activate dopamine D2 and D3 receptors and directly stimulate the striatal dopamine pathway to exert its effect. It can be used as a monotherapy regimen for early-stage Parkinson's disease, and can also be combined with levodopa for patients with middle and late-stage disease. While effectively improving motor symptoms, it reduces the risk of complications such as dyskinesia, and is one of the core medications for the long-term management of Parkinson's disease.

The global market size of ropinirole has remained at around USD 1.2 billion in recent years. With the annual increase in the prevalence of Parkinson's disease, the compound annual growth rate of the market is approximately 2.3%. Affected by the centralized procurement policy in the domestic market, the substitution rate of generic drugs has exceeded 85%. At present, more than 20 enterprises have obtained preparation approval documents, and the API supply side presents a competitive pattern consisting of original research manufacturers, large-scale domestic generic pharmaceutical enterprises, and specialized API enterprises. There is currently no verifiable publicly available data on the market size of ropinirole API in China.

The original research enterprise of ropinirole is GlaxoSmithKline (GSK), and the original research brand name is Requip. Its US compound patent expired in 2008, and its Chinese compound patent expired in 2010. The mainstream dosage forms of the original research product include conventional tablets and sustained-release tablets. The specifications of conventional tablets are 0.25mg, 1mg, 2mg and 4mg, and the specifications of sustained-release tablets are 2mg, 4mg and 8mg. The original research product has been included in the FDA Reference Listed Drug Catalogue, and the original research sustained-release tablet was officially included in the *Catalogue of Reference Listed Drugs of Chemical Drugs (23rd Batch)* of China in 2019. Up to now, there have been 5 registration entries of ropinirole API on the API Registration Platform of China CDE, among which 3 have been publicized as Status A. Multiple generic versions of both ropinirole conventional tablets and sustained-release tablets have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ropinirole API, which can fully meet the needs of R&D and production links such as impurity research and quality control. Most of the products are in stock. Spot orders placed before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable and reliable support for the quality research work of pharmaceutical enterprises.