Phenylephrine

Among sympathetic nervous system therapeutic drugs, α₁ adrenoceptor agonists are an important category in the fields of perioperative care and otorhinolaryngology. Phenylephrine is a representative variety with a long history of clinical application and widely verified safety. By selectively activating α₁ receptors on vascular smooth muscle, it rapidly contracts peripheral blood vessels and raises arterial blood pressure without significantly increasing the heart rate. Clinically, it is mainly used for the emergency treatment of anesthesia-induced hypotension, can also be used as a decongestant to relieve nasal mucosal congestion and swelling, and is often used for pupil dilation procedures during ophthalmic examinations. Its applicable population covers adult surgical patients, patients with allergic rhinitis and people receiving ophthalmic diagnosis and treatment, and some pediatric indications have also been recommended by clinical guidelines.

At present, the global phenylephrine market size is stably around USD 320 million, with a compound annual growth rate maintained at 4.1%. The growth momentum mainly comes from the steady increase in global surgical volume and the expansion of demand for over-the-counter otorhinolaryngology drugs. The Chinese market accounts for approximately 17% of the global share. The API supply side is dominated by local enterprises, and the overall competition pattern is relatively fragmented. Currently, 12 enterprises have obtained API production approvals, and no leading enterprise has formed a monopoly. After the implementation of centralized procurement, the cost pressure on the preparation side is transmitted to the API side, and the bargaining space of suppliers with compliant production capacity has increased.

The original research enterprise of phenylephrine is Novartis, and the original research brand name is Neo-Synephrine. Its core compound patent in the United States expired in 1971, and the core preparation patent expired in 2006. The main dosage forms of the original research product include injection (10mg/ml, 1ml specification), nasal spray (0.5% concentration) and ophthalmic eye drops (2.5%, 10% concentration). Among them, the injection has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs*, and is also included in the FDA Reference Preparations Catalogue. The domestic API registration platform shows a total of 18 valid API registration numbers, 11 of which have been activated and can be used for association. 27 phenylephrine preparation varieties have been approved for marketing in China, covering clinically commonly used dosage forms such as injections and nasal drops. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for phenylephrine API. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support API registration, declaration and quality research work. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can quickly respond to the sample demand of R&D and production ends.