Alfuzosin

In response to the clinical demand for the treatment of urination disorders in patients with benign prostatic hyperplasia (BPH), highly selective α1 receptor antagonists are an important first-line treatment option. As a representative variety of this class of drugs, alfuzosin can block α1A/α1D receptors on the smooth muscles of the prostate, bladder neck and urethra, relax smooth muscle tissues and reduce urethral pressure. It can rapidly relieve lower urinary tract symptoms such as frequent urination, urgent urination and dysuria without affecting blood pressure, and is suitable for long-term treatment of patients with moderate to severe BPH, and can also be used for adjuvant intervention in patients with acute urinary retention. It has better safety compared with non-selective α receptor blockers, and is especially suitable for elderly patients with underlying diseases.

The global market size of alfuzosin has long been stable in the range of USD 1.2 to 1.5 billion. As the global population aging deepens, the prevalence of BPH increases year by year, and the compound annual growth rate of the market remains at around 2.3%. For the domestic market, the sales of alfuzosin at the terminal of public medical institutions are approximately RMB 320 million. Currently, generic drugs account for more than 85% of the market, and oral preparations from 17 domestic enterprises have passed the consistency evaluation. In the local centralized procurement in 2022, the average price of this variety was reduced by 68%, which further promoted the increase of penetration rate in the primary market.

The original developer of alfuzosin is Sanofi, with the original brand name "Xatral". Its core compound patent expired globally in 2003, and the preparation patent in China expired in 2010. The main dosage forms approved for the original product are sustained-release tablets, with specifications including 2.5mg conventional tablets and 10mg sustained-release tablets. The 10mg sustained-release tablet has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also listed in the FDA Reference Preparations Catalogue. At present, there are 11 active active pharmaceutical ingredient (API) registration numbers (DMF) in China, among which 6 are domestic APIs. The original preparation and a number of domestic generic preparations have been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for alfuzosin API, covering all reference materials required for research including synthetic impurities, degradation impurities and enantiomers. Most products are in stock, and stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can be directly used for registration declaration and quality research scenarios, effectively shortening the R&D and compliance verification cycles of enterprises.