Tamsulosin

Benign prostatic hyperplasia (BPH) is a high-incidence urinary system disease among middle-aged and elderly men, with a prevalence rate of over 50% among people over 60 years old. It often causes lower urinary tract symptoms such as frequent urination and dysuria, which seriously affect the quality of life of patients. As a highly selective α1A adrenergic receptor blocker, tamsulosin can precisely block α1A receptors in the prostate, urethra and bladder neck, relax smooth muscles without affecting the contraction of bladder detrusor muscles. While rapidly relieving urination disorders, it greatly reduces the adverse reactions of traditional α receptor blockers such as orthostatic hypotension. It is a first-line drug for the pharmacotherapy of BPH, and can also be used in combination for auxiliary stone expulsion treatment of some ureteral calculi.

The global tamsulosin market size is stable at around USD 1.8 billion, and the annual growth rate of the Chinese market maintains at 6%~8%. In 2023, the sales volume in domestic sample hospitals exceeded RMB 1.5 billion. With the acceleration of the domestic aging process, the BPH patient population continues to expand, and the clinical demand for this variety will be further released. In terms of the competitive landscape, the original research product still accounts for about 35% of the market share. More than 30 domestic enterprises have been approved for generic preparations. After the centralized procurement, the terminal price has dropped by more than 70%, driving the rapid increase of the penetration rate in the primary market. The localization rate of upstream API has exceeded 80%, and the cost advantage has been further highlighted.

The original research enterprise of tamsulosin is Astellas Pharma, with the original brand name of Harnal®. The core compound patent expired in 2000, and the Chinese crystal form patent expired in 2014. The main dosage form of the original research product is sustained-release capsule with a conventional specification of 0.2mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparation Catalogue. Up to now, there are 36 tamsulosin API registration numbers on the API registration platform of China Center for Drug Evaluation (CDE), among which 22 have been activated. More than 30 domestic enterprises have been approved for preparations, covering two dosage forms: sustained-release capsules and sustained-release tablets. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of tamsulosin impurity reference standards, covering the whole research chain including starting materials, intermediates and degradation impurities. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the whole process needs of API R&D, quality research and compliance declaration.