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ST诺泰通过药品cGMP现场检查
Zhi Tong Cai Jing· 2025-08-05 08:27
Core Viewpoint - ST诺泰 has received the CBPF-GMP certificate from Brazil's ANVISA, indicating compliance with international production quality standards for its active pharmaceutical ingredients, semaglutide and liraglutide [1] Group 1: Regulatory Compliance - The company’s production line for semaglutide and liraglutide has passed the cGMP inspection by Brazil's health authority, ANVISA [1] - This certification follows previous approvals from the FDA and MFDS, showcasing the company's adherence to global regulatory standards [1] Group 2: Market Implications - The successful certification enhances the company's capability to market and promote its products in international markets, particularly in Brazil [1] - The recognition from a PIC/S member reinforces the company's commitment to maintaining high-quality production standards [1]
ST诺泰(688076.SH)通过药品cGMP现场检查
智通财经网· 2025-08-05 08:26
Core Viewpoint - ST诺泰 has received the CBPF-GMP certificate from Brazil's National Health Surveillance Agency (ANVISA), indicating compliance with international production quality standards for its active pharmaceutical ingredients, semaglutide and liraglutide [1] Group 1 - The inspection covered the company's cGMP system at its Lianyungang factory, which includes the production lines for semaglutide and liraglutide [1] - The company has now passed compliance checks from multiple international regulatory bodies, including the FDA and MFDS, enhancing its credibility in the global market [1] - This certification will facilitate the company's product sales and promotion in overseas markets, aligning with international regulatory standards [1]