Global Trade Business of Characteristic APIs, Intermediates and Pharmaceutical Excipients

Business Scope and Service Details

The company is mainly responsible for the global market promotion, international registration and filing, customer customized production and export business of the Group's characteristic APIs, pharmaceutical intermediates and pharmaceutical excipients. At the same time, it carries out import procurement and domestic distribution of high-quality APIs and pharmaceutical excipients from around the world. The core covered categories and services include:

1. Full Category Product Matrix: Anti-infection, antipyretic and analgesic, vitamin, electrolyte, cardiovascular chemical APIs; key synthetic building blocks for preparation matching, customized pharmaceutical intermediates; full category of pharmaceutical excipients for injection, oral and external use.

2. Full-process Supporting Services: Provide full-cycle services including DMF document preparation and global filing, CEP/COS certification declaration coordination, process verification technical support, impurity research and stability data support, long-term supply chain agreement guarantee, and customized synthetic production.

Core Support: Group's Industrial Advantages

1. Integrated Industrial Chain Advantage of Preparations and APIs: The Group has realized the vertical integrated layout of "API synthesis - preparation production - terminal sales". Self-produced APIs are mainly supplied to the Group's own preparation production, with internal control quality standards much higher than the general standards of national pharmacopoeias. At the same time, it has the core advantages of controllable cost, stable supply and short delivery cycle.

2. Rich Experience in International Compliance Registration: A number of the Group's core APIs have completed EU CEP, US DMF and WHO pre-certification. We are familiar with the API registration regulations and technical requirements of the world's major markets, and can quickly assist customers in product access and compliance filing in target markets.

3. Flexible Production Capacity with Multi-technology Platforms: The Group has multi-technology production platforms including chemical synthesis, biological fermentation, refining and purification. It can not only realize large-scale production of ten-thousand-ton bulk APIs, but also undertake small-batch, high-activity, high-value-added customized API production, which perfectly meets the differentiated needs of customers in different countries and of different scales.

Global Customer Value

Global pharmaceutical enterprises, preparation manufacturers and API distributors can obtain: high-purity APIs and excipients in line with the standards of national pharmacopoeias, one-stop technical support for international registration and filing, long-term stable supply guarantee, strict quality control system homologous with preparations, and cost advantage with strong market competitiveness.