Core Insights - Northeast Pharmaceutical has officially obtained the CEP certificate for its core raw material product, fosfomycin trometamol, from the European Directorate for the Quality of Medicines (EDQM), marking a significant milestone as the first domestic pharmaceutical company to achieve this certification [1][2] - The CEP certificate serves as a "golden key" for entering the European and American markets, indicating that the product meets stringent quality standards that exceed typical international registration requirements [2] - The certification enhances Northeast Pharmaceutical's international brand value and strengthens China's position in the global antibiotic sector [2][3] Market Potential - Fosfomycin trometamol is recognized for its low resistance characteristics and is suitable for treating various infections, making it highly relevant in the context of the global antibiotic resistance crisis [3] - The demand for high-quality antibiotic raw materials in the European market is on the rise, and the CEP certification is expected to boost the market penetration of Northeast Pharmaceutical's products in Europe [3] Competitive Position - Northeast Pharmaceutical has established a robust international registration matrix, with approximately 20 raw material products having passed high-end registrations in various countries, including the EU, Japan, and Russia [4] - The company is a major supplier of vitamin C and holds significant positions in the global supply of fosfomycin and chloramphenicol, maintaining a competitive edge in the international market [4] - The company aims to leverage its CEP registration to enhance its global market share and transition from "product export" to "brand export," thereby gaining greater international respect for Chinese pharmaceuticals [5]
东北制药破局国际抗生素市场壁垒 国内首家斩获磷霉素氨丁三醇原料药CEP证书