On September 25, 2024, our API Ropivacaine Hydrochloride obtained the Certificate of Suitability of the European Pharmacopoeia (CEP Certificate) issued by the European Directorate for the Quality of Medicines (EDQM).
Products
English name: Ropivacaine Hydrochloride
Chemical name:
S-(-)-1-Propyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide hydrochloride monohydrate
English chemical name: (-)-(2S)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carbo
xamide hydrochloride monohydrate;
CAS No.: 132112-35-7
Molecular formula: C17H27ClN2O, H2O
Molecular weight:328.9
Clinical application: (1) Surgical anesthesia: epidural anesthesia, including cesarean section, subarachnoid anesthesia, regional block; (2) Acute pain control: continuous epidural infusion or intermittent single dose, such as postoperative or vaginal delivery analgesia, regional block.
Our company submitted the CEP registration application for ropivacaine hydrochloride to EDQM in April 2023, and obtained the CEP certificate in September 2024, which is the second company in China to obtain the CEP certificate for ropivacaine hydrochloride (total 8 in the world). The successful obtaining of CEP certificate for Ropivacaine Hydrochloride is another milestone event of great significance in the development history of our company, which marks that our R&D and innovation ability of APIs and production quality management level have reached a new level.
Our company has submitted the registration declaration of many products in Europe, America and other countries, and more products will be registered internationally in the future. The company will take this European CEP certificate as a new starting point, consolidate the foundation, innovate, base on the present and create the future! We firmly believe that the company will have more products through the international registration, to help the company's API business development and create a new situation in the international competition!
