Chenghui Shuangda
We are proud to announce that our pharmaceutical ingredient Tetracaine Hydrochloride has been granted the Certificate of Suitability to the European Pharmacopoeia (CEP) by the European Directorate for the Quality of Medicines (EDQM) on August 20, 2025. This marks a significant milestone as we become the first company in China and one of only three global manufacturers to hold this certification for this critical local anesthetic.
CAS No.: 136-47-0
Molecular Formula: C15H24N2O2•HCl
Molecular Weight: 300.83
Applications: Reversible nerve block for surface anesthesia, infiltration anesthesia, nerve block, and epidural anesthesia. With superior efficacy compared to procaine, it is widely used in clinical settings.
11-month approval timeline (from submission in September 2024), setting a new company record
5-business-day turnaround after defect resolution, demonstrating EDQM’s confidence in our quality system
Fourth CEP certificate for our company, reinforcing our commitment to global regulatory excellence
This achievement validates our R&D innovation and GMP compliance at international standards. As we expand our portfolio across the US, Europe, and beyond, this certification strengthens our competitive edge in global markets.
We will leverage this momentum to accelerate more international registrations, driving our API business forward with scientific rigor and strategic vision. Stay tuned for more breakthroughs as we continue to "Build Today, Shape Tomorrow."
