Warm congratulations to our API Articaine Hydrochloride for obtaining European CEP certificate.
Chenghui Shuangda
On 3 January 2025, our API Articaine Hydrochloride obtained the Certificate of Suitability for European Pharmacopoeia (CEP Certificate) issued by the European Directorate for the Quality of Medicines (EDQM). This is the third CEP certificate for our company, and we are the first company in China (9 companies in the world) to obtain the CEP certificate for Articaine Hydrochloride. Successfully obtaining the CEP certificate for Articaine Hydrochloride is another milestone event of great significance in the development history of our company, which marks that our API R&D and innovation ability and production quality management level have reached a new level!
Description of products
product name: Articaine Hydrochloride
Chemical name: Methyl 4-methyl-3-[[1-oxo-2-(propylamino)propyl]amino]-2-thiophenecarboxylate hydrochloride
English Chemical Name: 4-methyl-3-[[(2RS)-2-(propylamino)propanoyl]-amino]thiophene-2-carboxylate hydrochloride
CAS No.: 23964-57-0
Molecular Formula: C13H21ClN2O3S
Molecular weight:320.8
Application: Articaine hydrochloride is a kind of local anaesthetic drug of amide class, which has the dual effects of anaesthesia and analgesia, and is widely used in dental clinics, especially in dental anaesthesia. Articaine Hydrochloride has been used in domestic and foreign clinics for more than 40 years, with remarkable clinical anaesthesia effect and good safety tolerance.
Our company has submitted several products for registration 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, to consolidate the foundation, to innovate, to be based on the present, to 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!
