Quinine sulfate

In response to the clinical demand for treatments targeting chloroquine-resistant strains in malaria prevention and control, quinine sulfate, as a quinoline alkaloid antimalarial drug, exerts its effect by binding to the DNA of Plasmodium and inhibiting nucleic acid synthesis, and is one of the core drugs globally for tackling multidrug-resistant Plasmodium falciparum malaria. It is indicated for the treatment of severe malaria such as cerebral malaria and falciparum malaria, and still delivers reliable efficacy especially for populations infected with chloroquine-resistant Plasmodium. Meanwhile, it can also be used to relieve symptoms of nocturnal gastrocnemius spasm, and is a basic drug in the public health antimalarial system.

In the global antimalarial drug market, quinine sulfate, with its advantages of cost-effectiveness and low drug resistance, has an annual market size of approximately USD 120 million, with an average annual growth rate maintained at 3.7% in the past three years. From the perspective of competitive landscape, generic drugs account for more than 90% of the market share, and the main production areas are concentrated in India, China and Southeast Asia. Among them, quinine sulfate API produced in China accounts for around 42% of the global export volume due to its stable purity and strict impurity control, and is a core component of the global supply chain.

The original research enterprise of quinine sulfate is Bayer AG of Germany, with the original brand name Quinimax, and the core compound patent expired globally in 1943. The currently commonly used clinical dosage forms include tablets and injections. The specification of tablets is mostly 0.3g, and the specification of injections is 1ml:0.25g. The original research product has been included in the FDA Reference Listed Drug Catalog, and it has also been included in the *Catalog of Reference Preparations for Generic Chemical Drugs* in China. Up to now, 12 domestic enterprises have obtained CDE registration numbers (status A) for quinine sulfate API, and another 7 enterprises have obtained marketing approval for quinine sulfate tablets and injections. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full range of quinine sulfate impurity reference standards, covering all impurity types involved in the synthesis process and degradation pathways. The products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most specifications are available in stock, and orders placed before 16:00 can be shipped on the same day, which can provide stable reference material support for API production, preparation R&D and quality research links.