With the acceleration of generic drug consistency evaluation and innovative drug research and development, the compliance of the supply chain for imported active pharmaceutical ingredients (APIs) has directly determined the progress of research and development, the success or failure of registration, and the quality of the marketed formulations. Currently, a large number of pharmaceutical companies are facing risks such as registration supplements, supply disruptions, and quality deviations due to lax selection of API suppliers. A standardized supplier verification system is a rigid demand for research and development as well as procurement.

Our company specializes in the import of active pharmaceutical ingredients and has established a comprehensive verification system for industry-standard suppliers to prevent and control compliance risks from the source:

▶Qualification verification: official verification of overseas factories' GMP certificates, production licenses, and free sales certificates, checking the validity period, variety coverage, and regulatory punishment records;

▶Full-cycle supply: Supporting gram-level samples, pilot tests, BE tests, and commercial mass production, meeting the consumption needs at all stages of the project and solving the pain point of supply disruptions during scaling up;  

▶Registration coordination: Familiar with China's associated review rules, able to provide the registrant's authorization letter and a full set of application materials, and fully cooperate with supplementary submissions and on-site inspections;

▶Quality control: The development of formulations is matched with the crystal form, particle size, and impurity profile of the active pharmaceutical ingredient. Batch COA is provided with the goods, and batch-to-batch differences are strictly controlled.

For the first generic drug, relying on global compliant channel resources, we connect with overseas certified factories through three formal channels: international official databases, industry exhibitions, and mature pharmaceutical supply chains, rejecting non-compliant gray channels.

We possess the resources of active pharmaceutical ingredient (API) factories in India, a major country in generic drug production. With pharmaceutical business qualifications and a mature GSP management system, we can provide a one-stop service covering the entire process, including qualification verification, supply docking, import customs clearance, and registration technical support. This helps pharmaceutical companies avoid supply chain risks and accelerate the research, development, and application of generic and innovative drugs.

Dedicated to importing compliant active pharmaceutical ingredients, we strive to be your reliable supply chain partner for the research, development, and launch of your formulations.