Pramipexole

As a common neurodegenerative disease among middle-aged and elderly people, Parkinson's disease has long restricted the clinical therapeutic effect due to the dual troubles of motor complications and non-motor symptoms. Pramipexole is a non-ergot dopamine receptor agonist that can highly selectively activate dopamine D2 and D3 receptors. It can not only directly stimulate dopamine receptors to improve core motor symptoms such as tremor, rigidity and bradykinesia, but also relieve the comorbid depression of patients by acting on D3 receptors. It can be used as the initial treatment drug for patients with early-onset Parkinson's disease, and can also be combined with levodopa for patients with middle and advanced stages to reduce the occurrence of motor fluctuations. It is one of the core drugs in the whole-course management of Parkinson's disease.

The global pramipexole market size has maintained a steady growth trend for a long time. In 2023, the overall market size was close to USD 1.2 billion, with the Chinese market accounting for approximately 16%, and the compound annual growth rate maintained at around 7%. At present, the domestic market is coexisted by original research drugs and generic drugs. With the implementation of the centralized procurement policy, the market share of generic drugs has increased to more than 60%, and the demand for API has continued to expand accordingly. At this stage, the number of domestic approved generic drug manufacturers has exceeded 15, and the compliance and stability of upstream API supply have become the core competitiveness elements of preparation enterprises.

The original research enterprise of pramipexole is Boehringer Ingelheim, and the original research brand name is Sifrol. Its core compound patent expired in the United States in 2011, and the core patent in China expired in 2013. The main dosage forms of the original research include conventional tablets and sustained-release tablets. The specifications of conventional tablets are 0.125mg, 0.25mg and 1mg, and the specifications of sustained-release tablets are 0.375mg, 0.75mg, 1.5mg, 3mg and 4.5mg. Relevant dosage forms have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA Reference Preparation Catalogue. At present, pramipexole APIs of nearly 30 domestic enterprises have completed registration with the CDE and obtained Class A status, and the approved and marketed preparation varieties cover two dosage forms: conventional tablets and sustained-release tablets. (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 pramipexole API, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference standard requirements in the process of API R&D, quality research and production.