Tunodafil

Erectile dysfunction (ED), a common reproductive system disease in adult males, has an onset directly related to the degradation effect of phosphodiesterase 5 (PDE5) on cyclic guanosine monophosphate. There is a long-standing clinical demand for PDE5 inhibitors with long-acting effects and low adverse reactions. Tadalafil is a new generation of highly selective PDE5 inhibitor. It relaxes the smooth muscle of the corpus cavernosum to promote blood inflow by specifically inhibiting the activity of PDE5. Meanwhile, it has extremely low affinity for other phosphodiesterase subtypes, and the incidence of adverse reactions is significantly lower than that of early similar drugs. In addition to being approved for the treatment of male erectile dysfunction, this drug can also be used to improve lower urinary tract symptoms related to benign prostatic hyperplasia. The applicable population covers patients with related diseases aged over 18 without serious cardiovascular contraindications. The longest duration of drug efficacy can reach 36 hours, which greatly reduces the binding restriction between medication time and sexual life.

At present, the global market size related to tadalafil has exceeded 1.2 billion US dollars, and the compound annual growth rate in the past three years has maintained at around 7.2%. The growth mainly comes from the increase in the penetration rate of primary andrology diagnosis and treatment and the expansion of demand for the indication of benign prostatic hyperplasia. In terms of the domestic market, with the improvement of the standardization of andrology diagnosis and treatment, the compound annual growth rate of the terminal sales of this variety in the past five years has reached 11.8%. The current competitive pattern is that the original research product dominates the high-end market. After passing the consistency evaluation, a number of generic drug enterprises have rapidly penetrated the primary market. The winning bid price in centralized procurement has decreased by more than 90% compared with the highest price of the original research product, further reducing the medication burden of patients.

The original research enterprise of tadalafil is Eli Lilly and Company in the United States, and the original research trade name is Cialis. The expiration time of its core compound patent in the United States is 2017, and the expiration time of the core compound patent in China is 2020. At present, the original research dosage forms approved in China are mainly oral tablets, with four specifications including 2.5mg, 5mg, 10mg and 20mg. They have been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the China NMPA, and are also reference preparations designated by the FDA. Up to now, more than 30 domestic enterprises have obtained CDE registration approval for tadalafil API, and more than 50 tablet preparations have been approved for marketing, all of which have passed or are deemed to have passed the consistency evaluation. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of tadalafil impurity reference standards, covering all key impurity reference substances in the synthesis and degradation processes. All products meet the compliance requirements of both Chinese Pharmacopoeia and FDA regulations. Most products are in regular stock. Orders for in-stock products paid before 16:00 can be shipped on the same day, which can fully meet the reference substance requirements of the whole process such as generic drug research and development, quality research, and consistency evaluation.