原料药利拉鲁肽

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ST诺泰:公司原料药生产线通过巴西卫生监督局cGMP现场检查
Mei Ri Jing Ji Xin Wen· 2025-08-05 08:23
Core Viewpoint - ST诺泰 has received the PIC/S GMP certificate from Brazil's National Health Surveillance Agency, indicating compliance with international production quality management standards, which will enhance the company's ability to market its products overseas [1] Group 1: Regulatory Compliance - The company has successfully passed another overseas compliance inspection following approvals from the US FDA and South Korea's MFDS [1] - The certification covers the cGMP system at the company's Lianyungang factory, which includes the production of active pharmaceutical ingredients Semaglutide and Liraglutide [1] Group 2: Market Implications - This certification is expected to further promote the company's products in international markets, enhancing sales and marketing efforts [1]
四川双马:关于控股子公司湖北健翔获得出口欧盟证明文件的公告
Zheng Quan Ri Bao Zhi Sheng· 2025-07-30 11:42
Core Viewpoint - Sichuan Shuangma announced that its subsidiary Hubei Jianxiang Biopharmaceutical Co., Ltd. received compliance certificates from the Hubei Provincial Drug Administration, confirming that its production line for the active pharmaceutical ingredient Liraglutide meets GMP standards equivalent to those of the EU and WHO [1] Group 1 - Hubei Jianxiang received the "GMP Compliance Inspection Notification" and "Written Confirmation for Active Substances Exported to EU" from the Hubei Provincial Drug Administration [1] - The A101 production line for Liraglutide at Hubei Jianxiang was inspected and found to comply with China's GMP requirements [1] - The GMP standards met by Hubei Jianxiang are equivalent to those set by the EU, WHO, and ICH Q7 guidelines [1]
四川双马控股子公司湖北健翔获得出口欧盟证明文件
Zhi Tong Cai Jing· 2025-07-30 07:56
Core Viewpoint - Sichuan Shuangma's subsidiary, Hubei Jianxiang Biopharmaceutical Co., Ltd., has received compliance certificates from the Hubei Provincial Drug Administration, indicating that its production line meets GMP standards equivalent to those of the EU and WHO [1] Group 1 - Hubei Jianxiang has obtained the "Notice of Compliance Inspection for Drug GMP" and "Certificate of Export of Raw Materials to the EU" from the Hubei Provincial Drug Administration [1] - The A101 production line for the raw material drug Liraglutide has passed the on-site inspection and complies with China's GMP requirements [1] - The GMP compliance is recognized as equivalent to the standards set by the EU, WHO, and ICH Q7 guidelines for raw material drug production [1]
四川双马(000935.SZ)控股子公司湖北健翔获得出口欧盟证明文件
智通财经网· 2025-07-30 07:52
Core Viewpoint - Sichuan Shuangma (000935.SZ) announced that its subsidiary Hubei Jianxiang Biopharmaceutical Co., Ltd. has received the GMP compliance inspection notice and EU export certificate from the Hubei Provincial Drug Administration, indicating compliance with international drug production quality management standards [1] Group 1 - Hubei Jianxiang's A101 workshop production line for the raw material drug Liraglutide has passed the on-site inspection by the Hubei Provincial Drug Administration [1] - The compliance with China's GMP standards is equivalent to the requirements set by the EU, World Health Organization, and ICH Q7 guidelines [1]