Chenghui Shuangda
On October 9, 2025, our company's active pharmaceutical ingredient (API) Lidocaine received approval for its European CEP (Certificate of Suitability to the European Pharmacopoeia) registration from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Our company submitted the CEP registration application for Lidocaine to EDQM in June 2024, and it was approved in October 2025, successfully obtaining the CEP certificate. We are the first company in China to receive the Lidocaine CEP certificate, and there are only seven companies globally with this certification.
We have already submitted registration applications for multiple products in Europe, the United States, and other countries, with several products already approved. In the future, we will continue to expand our international registration efforts for more products.