Chenghui Shuangda
On December 19, 2025, our company reached a pivotal milestone in international pharmaceutical development, as the European Pharmacopoeia Suitability Certificate (CEP) for the active pharmaceutical ingredient (API) Prilocaine was officially granted by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Prilocaine, an amide-type local anesthetic, exerts its therapeutic effect by stabilizing nerve cell membranes through the inhibition of ion flow required for nerve impulse generation and transmission. Structurally and functionally analogous to lidocaine, it offers a prolonged duration of action with reduced systemic toxicity—particularly a lower cardiac risk profile—making it a preferred choice for intravenous regional anesthesia.
The successful attainment of the CEP certificate for Prilocaine API stands as a radiant milestone in our company’s developmental journey. This achievement not only signifies the international recognition of our integrated capabilities in research, production, and quality control but also serves as a global passport for our excellence. Standing at this new height, we are committed to strengthening our foundations, pursuing innovation with unwavering determination, and propelling more high-quality products onto the world stage to forge a new era of brilliance in the global API sector.
In June 2024, our company submitted the CEP registration application for Prilocaine to EDQM. After a year and a half of meticulous preparation, rigorous documentation, and relentless effort, we finally received the joyous news of approval in December 2025.
This CEP certificate marks our sixth such certification this year and, more importantly, positions us as the first company in China to obtain this prestigious credential for Prilocaine (globally, only seven enterprises have achieved this distinction). This accomplishment further underscores our leading position in the industry and reinforces our commitment to delivering world-class APIs.
With the CEP certification in hand, we are poised to expand our global footprint, deepen partnerships with international pharmaceutical leaders, and continue driving innovation in the API sector. Our vision is to become a trusted partner for the global pharmaceutical community, delivering safe, efficacious, and high-quality APIs that meet the highest regulatory standards.
Join us in celebrating this milestone and shaping the future of global API excellence!
