Carbazochrome

Hemorrhagic diseases related to capillary injury have long been a common demand in clinical bleeding management. As an oxidative derivative of epinephrine, carbazochrome is a procoagulant hemostatic drug. Its mechanism of action does not affect prothrombin activity, but reduces blood exudation by enhancing the resistance of capillaries to injury, decreasing capillary permeability, and promoting the retraction of broken capillary ends. It is mainly used clinically for hemorrhage caused by increased capillary permeability, such as idiopathic purpura, retinal hemorrhage, chronic pulmonary hemorrhage, gastrointestinal hemorrhage, epistaxis, hemoptysis, hematuria, hemorrhoidal hemorrhage, uterine hemorrhage, cerebral hemorrhage, etc. It can also be used in conjunction with surgical hemostasis procedures to reduce intraoperative oozing. The applicable population covers patients of all age groups with the above-mentioned bleeding risks, and the dosage for children should be adjusted under the guidance of a doctor.

As a mature hemostatic API that has been on the market for many years, the global market size of carbazochrome is stable at around USD 120 million, with a compound annual growth rate of approximately 2.1%. The demand is mainly concentrated in primary medical institutions and surgical perioperative scenarios. The domestic market is dominated by generic drug supply. In the past 3 years, the sales volume of hospital preparations has remained in the range of RMB 800 million to 1 billion. The main production areas of APIs are concentrated in Jiangsu and Shandong provinces. The existing compliant production capacity exceeds 200 tons per year, which can fully meet the needs of clinical and downstream preparation production, and there is no centralized volume-based procurement record yet.

The original research enterprise of carbazochrome is Novartis, with the original brand name Adrenosem. The core compound patent expired globally in 1970. At present, the main marketed dosage forms include tablets (1mg, 2.5mg, 5mg) and injections (5mg/1ml, 10mg/2ml). The original research-related dosage forms have been included in the FDA Reference Listed Drug Catalog, and the original research preparations have not been imported into China yet. The domestic marketed carbazochrome preparations are mainly generic drugs, involving two dosage forms: tablets and injections. As of now, there are 6 carbazochrome API registration information on the CDE API registration platform, 3 of which are in status A and can be legally associated with preparation declaration. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of carbazochrome impurity reference standards, covering all types of impurities such as synthesis process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can support the full process needs of API research and development, quality research and declaration.