Piperaquine

The iterative upgrading of antimalarial drugs has always been a core topic in the field of tropical disease prevention and control. As a 4-aminoquinoline antimalarial drug, piperaquine exerts its efficacy by inhibiting the DNA replication and hemoglobin digestion process of Plasmodium. Its long-acting property distinguishes it from short-acting antimalarial drugs, and its antimalarial activity can be maintained for several weeks after a single administration. At the clinical level, it is not only used for the treatment of falciparum malaria and vivax malaria, but also can be used as a prophylactic drug for populations in high malaria endemic areas. In recent years, as one of the core components of compound antimalarial preparations, it has been widely used in the prevention and control programs of multidrug-resistant malaria, covering susceptible people of all ages in epidemic areas.

In the global antimalarial drug market, the annual market size of compound preparations containing piperaquine components exceeds 1.2 billion US dollars, with a compound growth rate of 8.2% in the past five years. The core growth driver comes from the public health procurement demand in high malaria incidence areas such as Africa and Southeast Asia. At present, the production capacity of piperaquine API is mainly concentrated in China and India, which together account for more than 90% of the global supply. Among them, Chinese enterprises, relying on their stable process quality control level, account for 60% of the WHO pre-qualified suppliers. With the continuous advancement of the global malaria elimination program, the demand for piperaquine API from the public procurement side is expected to maintain an average annual growth rate of more than 6%.

The original research enterprise of piperaquine is Bayer Pharmaceuticals, and the original brand name is Nivaquine. The core compound patent expired globally in 1970. At present, the mainstream dosage forms on the market include tablets, with common specifications of 0.25g and 0.5g (calculated as piperaquine). The original preparation has been included in the FDA reference preparation catalog. In terms of the domestic market, 12 domestic enterprises have obtained Class A status for their piperaquine APIs through CDE registration, which can be associated with preparation declarations. In addition, 17 piperaquine-related preparation varieties (including single-agent and compound preparations) have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of piperaquine impurity reference standards, covering the full-dimensional research needs such as synthesis process impurities and degradation impurities. Most of the products 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 Chinese Pharmacopoeia and FDA at the same time, and can fully support various R&D and production scenarios such as API quality research and preparation consistency evaluation.