Norepinephrine

Vasopressor therapy for acute and critical illnesses such as hemorrhagic shock and septic shock is one of the core demands in clinical rescue. Norepinephrine, as a catecholamine adrenergic receptor agonist, can stimulate both α and β adrenergic receptors simultaneously. It raises mean arterial pressure through potent peripheral vasoconstriction, while mildly enhancing myocardial contractility. It maintains the perfusion of vital organs without significantly increasing myocardial oxygen consumption. Currently, it is the first-line preferred drug for hypotension rescue in patients with various types of shock, and can also be used for local hemostasis in upper gastrointestinal bleeding, covering adult and pediatric critical patient groups in multiple clinical scenarios such as emergency departments, ICUs, and surgical perioperative periods.

The annual clinical use of norepinephrine preparations in China has maintained steady growth in recent years. In 2023, the terminal procurement scale of key domestic hospitals exceeded 1.2 billion yuan, with an annual compound growth rate maintained at around 8%. At present, the domestic preparation market is dominated by generic drugs, with more than 20 enterprises having passed the consistency evaluation. It has been included in the national centralized procurement scope, and the price of preparations has dropped by more than 90% after centralized procurement, driving the continuous increase in demand for API. Domestic API manufacturers are mainly concentrated in North China and East China, and the overall supply pattern is relatively stable.

The original research enterprise of norepinephrine is Sandoz AG, with the original brand name Levophed. Its core patent in the US market expired in 1979. The main marketed dosage form is injection, with specifications of 2ml:2mg and 4ml:4mg. The original research preparation has been included in the FDA Reference Listed Drug Catalogue, and no original research preparation has been approved for import in China yet. At present, more than 30 domestic enterprises have completed the registration of norepinephrine API in CDE and obtained the A status identification, corresponding to more than 60 approvals of generic preparations that have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for norepinephrine API. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises for quality research, stability investigation and registration declaration.