Levodopa

As a common neurodegenerative disease among middle-aged and elderly people, Parkinson's disease has symptoms such as bradykinesia and resting tremor that seriously affect the quality of life of patients, while levodopa is the cornerstone drug for the treatment of this disease. As a prodrug of dopamine, it can penetrate the blood-brain barrier and be converted into dopamine to supplement the deficiency of dopamine in the central nervous system, thereby improving the motor symptoms of Parkinson's disease. Levodopa is applicable to Parkinson's disease patients at all stages, and is currently the clinically recognized first-choice drug for symptomatic treatment of Parkinson's disease. It can also be used to treat neurological symptoms caused by hepatic encephalopathy.

The global levodopa market size is growing steadily. In 2023, the market size has exceeded 420 million US dollars, and the compound annual growth rate has remained at around 4.8%. The growth drivers mainly come from the intensification of global population aging and the continuous rise in the prevalence of Parkinson's disease. At present, China and India are the core suppliers of levodopa API in the world. Domestic API enterprises, with their mature synthesis processes and cost advantages, account for more than 60% of the global supply share. After the implementation of centralized procurement in the domestic preparation market, the penetration rate of generic drugs has increased to 85%, driving the continuous increase in demand for upstream APIs.

The original research enterprise of levodopa is Roche, and the original research trade name is Madopar, which is a compound preparation of levodopa and benserazide. Its core compound patent expired globally in 1973, and there is no core patent restriction at present. The main dosage form of the original research product is tablet, with the conventional specification of 200 mg levodopa + 50 mg benserazide. This product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. At present, more than 30 domestic enterprises have obtained CDE registration numbers for levodopa APIs, among which there are 18 registration numbers with the status of A. The levodopa and compound levodopa preparations of a number of enterprises have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the R&D and quality control needs of levodopa, CATO can provide a full set of impurity reference standards for this API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in different scenarios such as registration and declaration, quality research, etc.