Primaquine

Malaria is a major long-standing infectious disease challenge in the global public health field, and drugs targeting the exo-erythrocytic stage and gametocytes of Plasmodium are the key to blocking transmission and reducing recurrence. Primaquine is an 8-aminoquinoline antimalarial drug. By inhibiting the oxidation of Plasmodium mitochondria and interfering with its nucleic acid metabolism, it can efficiently kill the hypnozoites of Plasmodium vivax and Plasmodium ovale in the exo-erythrocytic stage, and can also kill the gametocytes of all types of Plasmodium. It is currently the only core drug approved for radical cure of Plasmodium vivax malaria and blocking malaria transmission. It is mainly used for radical prevention of malaria and transmission control, and its applicable population includes patients with current Plasmodium vivax and Plasmodium ovale infections and susceptible populations in high-prevalence areas. It is a key drug variety in the Global Malaria Eradication Action Plan.

At present, the global antimalarial drug market size is stable at around USD 3.5 billion. Among them, primaquine, as a basic antimalarial drug, has an annual demand of about 1,200 tons, with a compound annual growth rate maintained at 3.2%. Due to the early expiration of patents, the global primaquine market is dominated by generic drug supplies. China and India are the major API producers, accounting for more than 85% of the global supply in total. In the Chinese market, primaquine is included in the National Essential Medicines List and is also a core variety of antimalarial drug reserves. The procurement demand at the public medical end is stable. With the increase in international aid projects and export demand from the African market, the order scale of domestic API enterprises maintains a steady growth trend.

The original research enterprise of primaquine is GSK (GlaxoSmithKline), and the original brand name is Primaquine. Its core compound patent expired globally in the 1970s, and there is no core patent restriction at present. The main dosage form approved by the original research is tablet, with a specification of 15mg (calculated as primaquine). Its tablet has been included in the FDA Reference Listed Drug Catalog, and is also a reference preparation included in the China Listed Drug Catalog. Up to now, 3 enterprises have obtained A-status registration for primaquine API on the API registration platform of China CDE, and a number of domestic enterprises have obtained marketing approval for primaquine tablets, which can fully meet the domestic clinical and export supply needs. (Data as of October 2024, please refer to the official CDE website for the latest information)

For the quality control and compliant R&D needs of primaquine, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for enterprises' API registration, process optimization and quality research.