Hydroxychloroquine

The long-term management of autoimmune diseases has always faced the clinical demand for controlling inflammation and reducing organ damage. Hydroxychloroquine, as a core variety of disease-modifying anti-rheumatic drugs (DMARDs), exerts immunomodulatory and anti-inflammatory effects by inhibiting Toll-like receptor signaling and reducing the release of pro-inflammatory cytokines, while also having mild antimalarial activity. In clinical practice, it is a basic medication for systemic lupus erythematosus, which can reduce disease activity and the risk of recurrence. It is also used for the long-term treatment of autoimmune diseases such as rheumatoid arthritis and Sjögren's syndrome. In addition, pregnant women can use it in a standardized manner when the doctor assesses that the benefits outweigh the risks, and it is currently one of the few rheumatic immunology drugs proven to be relatively safe during pregnancy.

The global hydroxychloroquine market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.28 billion, with a compound annual growth rate of around 4.2%. Due to the rigid clinical demand and long medication cycle, generic drugs have become the main force in the market. China and India are the core supply regions of hydroxychloroquine API in the world. The competitive pattern of domestic API manufacturers is relatively concentrated, with the top 3 enterprises accounting for more than 70% of the domestic supply share, and their products are mainly exported to Europe, America, Southeast Asia and other regions. In the national centralized drug procurement, the oral regular-release dosage forms of hydroxychloroquine have been included in multiple batches of centralized procurement catalogs, and the price of selected products has dropped by more than 60%, which has greatly improved the accessibility of medication for patients.

The original developer of hydroxychloroquine is Sanofi, with the original brand name Plaquenil (Fenle), and its core compound patent expired globally in 1989. The mainstream dosage form of the original product is oral tablet, with specifications of 200mg and 100mg. This original product has been included in the NMPA Reference Listed Drug Catalog and the FDA Reference Listed Drug Catalog. In terms of domestic API registration, more than 20 enterprises have obtained CDE registration numbers for hydroxychloroquine API so far, most of which are in status A (activated, can be associated with preparation declaration for marketing). A number of domestic enterprises have obtained approval for the marketing of hydroxychloroquine oral tablets, and the supply covers medical institutions at all levels across the country. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for hydroxychloroquine 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 meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of API R&D, quality research, declaration and registration, etc.