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Kai Yuen Pharmaceutical received a new CEP certificate for erythromycin
2022-05-05Return list
On April 19, 2022, we received a new certificate of suitability for erythromycin in European Pharmacopoeia issued by the European Council for The Quality of Medicines (EDQM), namely THE CEP Certificate, with the number CEP 2020-304.
Erythromycin is an old variety produced by our company for many years and has obtained CEP certificate as early as 2011. Due to the change of the source of intermediates, the company applied for a new CEP certificate in time to meet the new market needs. In recent years, EDQM has become more stringent in the approval of apis, especially in the control of impurities. Since July 2018 in valsartan apis detection nitrosamines impurities, EDQM requirements and new application of other listed API will nitrosamines impurity analysis, and combined with production process, analysis and study of all possible impurities, to this end, our company a lot of research work on all relevant departments actively. After two defect responses, EDQM approval was finally obtained.
The new CEP certificate of erythromycin will open the door for our company to sell erythromycin in The European market after the change of intermediate source.
Fu Shuqun
