Allopurinol

In the chronic disease management of hyperuricemia and gout, xanthine oxidase inhibitors are first-line core drugs for uric acid reduction, and allopurinol is a classic variety with the longest clinical application history in this drug class. It competitively inhibits the activity of xanthine oxidase, blocks the metabolic conversion of hypoxanthine and xanthine to uric acid, fundamentally reduces serum uric acid concentration, and reduces the deposition of urate in joints, kidneys and other parts. In addition to being applicable to patients with primary and secondary hyperuricemia, recurrent or chronic gout, it can also be used for the treatment of tophus, uric acid kidney stones and uric acid nephropathy, and is a basic drug recommended by guidelines of many countries for long-term control of hyperuricemia.

At present, the global allopurinol market size is stable at around USD 1.2 billion. With the continuous rise in the prevalence of hyperuricemia, the compound annual growth rate in the past five years has maintained at 4.2%. In terms of the domestic market, allopurinol has been included in the national centralized procurement catalog, and the price of the selected preparations has dropped by more than 90%, which further improves clinical accessibility, and the domestic annual sales remain above RMB 800 million. The competitive landscape is dominated by generic drugs. The production of APIs is concentrated in China and India, and the domestic compliant production capacity accounts for more than 60% of the global supply. The API registration status of leading enterprises is all A, which can be directly associated with preparation declaration.

The original research enterprise of allopurinol is Boehringer Ingelheim, Germany, with the original research trade name ZYLOPRIM. The compound patent in the US market expired in 1980, and the core formulation patents also fully expired before 1990. The main formulations approved by the original research are tablets, with specifications of 100mg and 300mg, which have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. Up to now, there are 22 allopurinol API registration records on the API registration platform of China National Medical Products Administration Center for Drug Evaluation (CDE), of which 17 are in status A. More than 30 domestic enterprises have obtained approval for the marketing of allopurinol tablets and capsules, and the original research preparation has not yet entered the Chinese market. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of allopurinol impurity reference standards, covering all types of pharmacopeial impurities, degradation impurities and process impurities, which can meet the qualitative and quantitative requirements of impurities in different R&D stages. Most products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can be directly used for API quality research, preparation consistency evaluation and submission of registration application materials.