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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
Zheng Quan Shi Bao Wang· 2025-06-12 09:46
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:“智造+创新”双轮驱动 擘画产业升级新蓝图
Mei Ri Jing Ji Xin Wen· 2025-05-21 15:23
Group 1 - The core viewpoint is that Northeast Pharmaceutical is transforming from a traditional manufacturing enterprise to a technology-driven pharmaceutical group through its "Digital Dongyao" strategy and forward-looking layout in the biopharmaceutical field [1] - The company is enhancing production efficiency and product quality through intelligent manufacturing, utilizing new technologies such as big data, cloud computing, and artificial intelligence [2] - Northeast Pharmaceutical is actively promoting green production and energy management to contribute to sustainable development [2] Group 2 - The company is focusing on biopharmaceutical innovation as a key direction for transformation, increasing R&D investment, and accelerating new drug development [3] - Northeast Pharmaceutical has established a collaborative R&D framework across Shenyang, Beijing, and Shanghai, optimizing its product structure based on clinical needs [3] - The company has launched 22 new products since 2021 and is entering the cell therapy market through the acquisition of Dingcheng Peptide Source in 2024 [3]