Sildenafil

Pulmonary arterial hypertension is a type of cardiopulmonary vascular disease with high lethality, while male erectile dysfunction (ED), as a highly prevalent male reproductive system disease, both have a significant impact on the quality of life of patients. Sildenafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor. It reduces the degradation of cyclic guanosine monophosphate by inhibiting the activity of PDE5, relaxes smooth muscle and increases local blood flow. It was originally used for the treatment of pulmonary arterial hypertension, and was subsequently approved for the indication of male ED. It is also a commonly used therapeutic drug for persistent pulmonary hypertension of the newborn, a rare disease, covering adult and some pediatric patient groups.

The global market size of sildenafil API was approximately USD 1.28 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to remain at around 4.2%. After the expiration of its original research patent in many countries, the proportion of generic drugs has climbed to more than 85%. China and India are the world's core exporters of sildenafil API. Domestically produced APIs in China, with higher purity standards, have an increasing share in the European and American regulated markets year by year. At present, there are more than 20 domestic enterprises that have been approved for sildenafil API. After the implementation of the centralized procurement policy, the demand of downstream preparation manufacturers for upstream supply with compliance, high quality and stable cost continues to rise.

CATO can provide a full set of impurity reference standards for sildenafil API. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, with sufficient spot reserves. They can directly match the use needs of pharmaceutical enterprises in the full scenarios of registration and declaration, quality research and batch release, facilitating the efficient advancement of R&D and production processes.