商业化中间体和原料药
Search documents
富祥药业(300497.SZ):通过美国FDA现场检查
Ge Long Hui A P P· 2025-11-06 08:03
Core Viewpoint - Fuxiang Pharmaceutical successfully passed the FDA's cGMP inspection, indicating its compliance with international quality standards and enhancing its capability to supply commercial intermediates and APIs to the US and global markets [1] Group 1: FDA Inspection Results - The company underwent an FDA cGMP inspection from August 11 to August 14, 2025, covering various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control [1] - The inspection resulted in a VAI (Voluntary Action Indicated) outcome, marking the third successful cGMP inspection by the FDA for the company [1] Group 2: Implications for the Company - The successful inspection reflects the company's commitment to high international quality standards and validates the effective operation of its management system [1] - This achievement is expected to boost the company's competitiveness and support its goals for international market expansion [1]
富祥药业通过美国FDA现场检查
Zhi Tong Cai Jing· 2025-11-06 07:57
Core Viewpoint - Fuxiang Pharmaceutical successfully passed the FDA's cGMP inspection, indicating its compliance with international quality standards and enhancing its capability to supply commercial intermediates and APIs to the US and global markets [1] Group 1: FDA Inspection Results - The company underwent an FDA cGMP inspection from August 11 to August 14, 2025, covering various GMP systems including quality, material management, production, equipment, packaging, labeling, and laboratory control [1] - The inspection resulted in a VAI (Voluntary Action Indicated) outcome, marking the third successful cGMP inspection by the FDA for the company [1] Group 2: Implications for the Company - The successful inspection reflects the company's commitment to high international quality standards and validates the effective operation of its management systems [1] - This achievement is expected to boost the company's competitiveness and support its goals for international market expansion [1]
富祥药业:通过美国FDA现场检查
Xin Lang Cai Jing· 2025-11-06 07:57
Core Insights - The company successfully passed a cGMP inspection by the FDA from August 11 to August 14, 2025, covering various quality and management systems [1] - This marks the third successful cGMP inspection by the FDA, indicating the company's quality systems are aligned with international standards [1] - The successful inspection qualifies the company to continuously provide commercial intermediates and active pharmaceutical ingredients for the U.S. and global markets [1]
富祥药业(300497.SZ)通过美国FDA现场检查
智通财经网· 2025-11-06 07:55
Core Viewpoint - Fuxiang Pharmaceutical successfully passed the FDA's cGMP inspection, indicating its compliance with international quality standards and enhancing its capability to supply commercial intermediates and APIs to the US and global markets [1] Group 1: FDA Inspection Results - The company underwent an FDA cGMP inspection from August 11 to August 14, 2025, covering various GMP systems including quality, material management, production, equipment, packaging, labeling, and laboratory control [1] - The inspection resulted in a VAI (Voluntary Action Indicated) outcome, marking the third successful cGMP inspection by the FDA for the company [1] Group 2: Implications for the Company - The successful inspection reflects the company's commitment to high international quality standards and validates the effective operation of its management systems [1] - This achievement is expected to boost the company's competitiveness and support its goals for international market expansion [1]