Tadalafil

Male erectile dysfunction (ED), a urogenital system disease with high incidence among middle-aged and elderly men, has shown an increasing incidence trend in recent years, which has a significant impact on patients' quality of life and family harmony. Tadalafil belongs to the phosphodiesterase 5 (PDE5) inhibitor class of drugs. It inhibits PDE5 activity with high selectivity, reduces the degradation of cyclic guanosine monophosphate (cGMP), relaxes the smooth muscle of the corpus cavernosum, and promotes blood inflow to achieve erection. It is currently the first-line drug for clinical treatment of ED, and has also been approved for the treatment of pulmonary arterial hypertension, benign prostatic hyperplasia and other indications, with the applicable population covering patients with related diseases of different age groups.

The global market size of tadalafil has maintained steady growth in recent years, and the overall market size exceeded 3.8 billion US dollars in 2023. With the massive launch of generic drugs after patent expiration, the accessibility of the drug has been greatly improved, and the growth rate of the Chinese market is particularly prominent. In 2023, the domestic market size exceeded 4.5 billion yuan, with a compound annual growth rate of 12.7%. In terms of the competitive landscape, more than 30 domestic enterprises have obtained approval documents for tadalafil preparations at present. After the implementation of centralized procurement, the terminal price has dropped by more than 90%, and the share of generic drugs in the public medical institution market has exceeded 85%. On the API supply side, in addition to imported original research drugs, nearly 20 domestic enterprises have obtained API registration numbers, and the supply system is becoming increasingly mature.

The original research enterprise of tadalafil is Eli Lilly and Company in the United States, and the original research trade name is "Cialis". Its core compound patent in the United States expired in 2017, and the Chinese compound patent also expired in 2017. The main dosage forms of the original research marketed products include tablets, with specifications of 2.5mg, 5mg, 10mg and 20mg. They have been included in the Catalogue of Marketed Drugs in China as reference preparations, and are also included in the FDA Reference Preparation Catalog. Up to now, there are more than 40 tadalafil API registration information on the platform of the Center for Drug Evaluation (CDE) of China, among which more than 30 are in the status of "A" (i.e., already used in marketed preparations). The domestically approved tadalafil preparation varieties have covered multiple dosage forms such as tablets and oral dissolving films. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the needs of quality research and compliance declaration for tadalafil API, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support enterprises in the whole process of impurity research, quality standard establishment and registration declaration.