Fondaparinux sodium

【API structure】

【Project Description】

The fondaparinux sodium project, in collaboration with Qin Yong's team at West China School of Pharmacy, Sichuan University, after years of research and development, adopted a new synthesis route, reducing the original research's tedious total 75 synthesis steps to 52 steps, and its linear 45 steps to 23 steps. It greatly reduces the difficulty of industrialization and improves synthesis efficiency. At present, our company has submitted the application materials for this API project to CDE on March 2022. It is currently under review, and the registration number is Y20210001161. Our company's APIs have certain advantages in terms of quality, cost and production capacity. Quality: Purity is greater than 99.8%, single impurities are 0.10%, and total impurities are less than 0.2%, which is significantly better than the current market standard (single impurity NMT 0.3%, total price NMT 2.0%), and fully meets the current impurity consistency evaluation requirements for injections. High demands. Cost: Through high stereoselectivity reaction, separation and purification optimization and lean workshop management, we have significant cost advantages. Under the background of centralized procurement, we can provide strong support for customers to strategically control the cost of injections. Production capacity: We already have 3 GMP-passed API workshops in our production base, and currently there are 2 larger API workshops under construction. In the future, we can meet the output of more than 50kg/year, and can establish long-term strategic partners with customers. relation.