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联环药业:原料药产品左炔诺孕酮通过世界卫生组织预认证现场检查
Zhi Tong Cai Jing· 2025-11-10 09:04
公司本次顺利通过世界卫生组织的现场检查,表明公司相关生产线符合GMP要求,有利于公司继续保 持稳定的产品质量和持续稳定的生产能力,以满足相关药品的市场需求。本次该产品通过世界卫生组织 预认证现场检查不会对公司近期业绩产生重大影响。 联环药业(600513)(600513.SH)发布公告,公司于近日收到世界卫生组织(WHO)通知。世界卫生组织 预认证团队对公司原料药产品左炔诺孕酮(APIMF484,WHOAPI-484)的现场检查现已关闭,结果为符合 世界卫生组织良好生产规范(GMP)的标准。 ...
联环药业:原料药左炔诺孕酮通过世卫预认证现场检查
Xin Lang Cai Jing· 2025-11-10 09:01
Core Viewpoint - The company received notification from the World Health Organization that its raw material drug product, Levonorgestrel, has passed the site inspection, meeting the WHO's good manufacturing practice standards [1] Group 1: Inspection Details - The inspection took place from March 10 to March 13, 2025, covering the synthesis area and part of the cleanroom production lines [1] - The successful inspection is expected to help maintain product quality and production capacity [1] Group 2: Financial Impact - The inspection results are not expected to have a significant impact on the company's recent performance [1] - The drug master file review has not been closed, indicating uncertainty regarding future procurement [1]
联环药业(600513.SH):原料药产品左炔诺孕酮通过世界卫生组织预认证现场检查
智通财经网· 2025-11-10 08:59
公司本次顺利通过世界卫生组织的现场检查,表明公司相关生产线符合GMP要求,有利于公司继续保 持稳定的产品质量和持续稳定的生产能力,以满足相关药品的市场需求。本次该产品通过世界卫生组织 预认证现场检查不会对公司近期业绩产生重大影响。 智通财经APP讯,联环药业(600513.SH)发布公告,公司于近日收到世界卫生组织(WHO)通知。世界卫 生组织预认证团队对公司原料药产品左炔诺孕酮(APIMF484,WHOAPI-484)的现场检查现已关闭,结果 为符合世界卫生组织良好生产规范(GMP)的标准。 ...
联环药业:目前已有6个创新药 其中1个进入 III 期
Group 1: Company Overview and Product Development - The company focuses on innovative drugs primarily in cardiovascular, urology, oncology, and respiratory systems, with 6 innovative drugs in development, including 1 in Phase III, 2 in Phase I, and 3 in preclinical research [2] - The product Aipulete has shown strong market performance, with projected sales of 119 million tablets in 2024, representing a 30.28% increase from the previous year [2] - The company emphasizes innovation-driven development strategies, enhancing R&D platforms, increasing investment in technology innovation, and promoting digital transformation and sustainable development [2] Group 2: Export Strategy and International Development - The company primarily exports raw materials to markets in North America, Eastern Europe, Southeast Asia, South America, and Oceania [3] - The company established Unioncle Pharma LLC in the U.S. in 2023 to facilitate international collaboration and accelerate the internationalization of its R&D products [3] - The company is actively seeking opportunities for its newly developed raw materials through various channels to enhance its global presence [3] Group 3: Strategic Acquisitions - The company acquired Longyi Pharmaceutical to strengthen its market presence in Southwest China, aiming to create a dual-core driving pattern with its headquarters in the Yangtze River Delta [4] - Longyi Pharmaceutical has a dense distribution network and advantages in the outpatient market, which will accelerate the regional penetration of the company's existing products [4] - The company's national sales system will provide Longyi Pharmaceutical with more upstream pharmaceutical cooperation resources, expanding its wholesale categories [4]