药品国际认证与出口
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国药现代:克拉维酸系列、阿莫西林、米卡芬净钠等原料药获欧洲CEP认证
Mei Ri Jing Ji Xin Wen· 2025-11-05 09:56
Core Insights - The company, China National Pharmaceutical Group Modern (国药现代), has achieved multiple international certifications, including FDA, EMA, and PMDA, enabling it to export to over 60 countries and regions across Europe, Asia, Africa, and America [1]. Group 1: International Certifications - The company has received FDA certification for various cephalosporin and penicillin intermediates and raw materials, including products from its subsidiaries [1]. - Key products such as zidovudine and azithromycin from its Jiangsu subsidiary have also been FDA certified [1]. - The company’s clavulanic acid series, amoxicillin, and micafungin sodium have received European CEP certification [1]. Group 2: Product Range and Market Reach - The company’s main anti-infection and assisted reproduction raw materials have been certified by authorities in India, South Korea, and Japan [1]. - Major cephalosporin formulations from the company have received EU and WHO certifications, while its powder injection workshop has been certified by Australia’s TGA-GMP [1]. Group 3: Market Expansion and Future Plans - The company is responding to the global shortage of common antibiotics and vaccines, which is a widespread issue, including in the US [3]. - There is an emphasis on the necessity for Chinese companies to expand internationally, given the large domestic market of 1.4 billion people and a global market of 8 billion [3]. - The company is exploring plans to accelerate its overseas market expansion and international mergers and acquisitions [3].