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江苏诺泰澳赛诺生物制药股份有限公司 关于自愿披露通过药品GMP符合性检查的公告
Group 1 - The company’s subsidiary, Hangzhou Ausino Biotechnology Co., Ltd., has received a GMP compliance inspection notice from the Zhejiang Provincial Drug Administration, confirming that the active pharmaceutical ingredient (API) of Ograpivir Sodium has passed the GMP compliance check [1] - The inspection took place from January 14 to January 16, 2026, covering specific production lines and workshops related to the API [1] - The successful GMP compliance check reinforces the company's commitment to leading production and quality management systems, marking a milestone for the CDMO business in extending from advanced intermediates to APIs [1]
ST诺泰子公司通过药品GMP符合性检查
Zhi Tong Cai Jing· 2026-02-03 10:29
Core Viewpoint - ST诺泰's subsidiary, Hangzhou Ausino Biotechnology Co., Ltd., has successfully passed the GMP compliance inspection for its active pharmaceutical ingredient, Aogetwei Sodium, marking a significant milestone in its production capabilities [1] Group 1: Company Achievements - The company received the GMP compliance inspection notice from the Zhejiang Provincial Drug Administration, indicating its adherence to high production and quality management standards [1] - The successful inspection of the raw material production line at the Jiande factory reinforces the company's commitment to leading in both time and technology [1] Group 2: Business Implications - This achievement is pivotal for the company's CDMO (Contract Development and Manufacturing Organization) business, allowing it to extend its value from advanced intermediates to active pharmaceutical ingredients [1] - The milestone is expected to positively impact the company's efforts in expanding its client base for innovative pharmaceutical raw materials [1]
ST诺泰(688076.SH)子公司通过药品GMP符合性检查
智通财经网· 2026-02-03 10:24
Core Viewpoint - ST诺泰's subsidiary, Hangzhou Ausino Biotechnology Co., Ltd., has successfully passed the GMP compliance inspection for its active pharmaceutical ingredient, Aogtewei Sodium, marking a significant milestone in its production capabilities and quality management system [1] Group 1 - The Zhejiang Provincial Drug Administration issued a GMP compliance inspection notice to Ausino, confirming the successful inspection of the raw material production line at the Jiande factory [1] - The company emphasizes its commitment to "time-leading and technology-leading" business philosophy, which underpins its operational strategies [1] - The successful GMP compliance is seen as a milestone for the company's CDMO business, extending its value from advanced intermediates to raw materials [1]
ST诺泰(688076.SH):通过药品GMP符合性检查
Ge Long Hui A P P· 2026-02-03 10:24
Core Viewpoint - ST诺泰's subsidiary, Hangzhou Ausino Biotechnology Co., Ltd., has successfully passed the GMP compliance inspection for its active pharmaceutical ingredient, Aogtewei Sodium, marking a significant milestone in its production capabilities and quality management system [1] Group 1: Company Achievements - The company received the GMP compliance inspection notice from the Zhejiang Provincial Drug Administration, indicating its adherence to high production standards [1] - The successful inspection reinforces the company's commitment to "time-leading and technology-leading" operational philosophy [1] - The achievement is pivotal for the company's CDMO business, extending its value from high-level intermediates to active pharmaceutical ingredients [1] Group 2: Industry Implications - The compliance with GMP standards is expected to positively impact the company's ability to attract innovative pharmaceutical clients [1] - This milestone reflects the company's competitive edge in the pharmaceutical manufacturing sector, particularly in the production of innovative drug raw materials [1]
ST诺泰:建德工厂原料药生产线通过GMP符合性检查
Xin Lang Cai Jing· 2026-02-03 10:00
Core Viewpoint - ST诺泰's subsidiary, Hangzhou Ausainuo Biotechnology Co., Ltd., has successfully passed the GMP compliance inspection for the active pharmaceutical ingredient (API) Aogteweina, indicating adherence to quality management standards [1] Group 1 - The Zhejiang Provincial Drug Administration issued a GMP compliance inspection notice (No. 浙2026第0013号) to the company [1] - The inspection covered specific workshops and production lines for the API Aogteweina, including Workshop 1, Workshop 6, Workshop 9, and Production Line B [1] - The conclusion of the inspection confirmed that the production and quality management of the API Aogteweina met the requirements of the Good Manufacturing Practice (GMP) as revised in 2010 [1]