左炔诺孕酮
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联环药业:公司将依加大左炔诺孕酮等特色原料药的海外推广力度
Zheng Quan Ri Bao Wang· 2025-12-25 12:16
证券日报网12月25日讯 ,联环药业(600513)在接受投资者提问时表示,为应对原料价格波动风险, 联环集团(联环药业控股股东)构建了完整的产业链布局,联环集团旗下设有内蒙古圣氏化学、普林斯 医药等中间体生产企业,在内蒙古、安徽布局了两大中间体生产基地,保障了供应链安全。公司前身扬 州制药厂于1984年首次通过FDA现场检查,为全国首批通过FDA现场检查的企业之一。公司新厂区并于 2024年8月再次通过FDA现场检查。未来,公司将依托世界卫生组织(WHO)预认证优势,加大左炔诺 孕酮等特色原料药的海外推广力度,提升外销占比,将原料药业务打造为重要业绩增长点。 ...
早新闻 | 三部门重磅发声
Zheng Quan Shi Bao· 2025-12-24 00:06
宏观热点 三部门:不断完善学前教育成本分担机制,做好收费政策与免费政策的衔接 国家发展改革委、教育部、财政部发布关于完善幼儿园收费政策的通知,其中提出,各地要统筹制定好 财政补助和收费政策,不断完善学前教育成本分担机制,做好收费政策与免费政策的衔接,将完善收费 政策与提升服务质量有机结合。支持和保障幼儿园运转,落实相关税费减免政策,幼儿园用水用电用气 用热按照居民生活类价格执行。县级及以上教育行政部门要按照地方出台的认定标准组织做好普惠性民 办幼儿园认定工作,并定期发布更新本地各类型幼儿园名单。 财政部拟发行2025年记账式贴现(八十一期)国债 招标面值总额600亿元 财政部拟发行2025年记账式贴现(八十一期)国债。本期国债为期限182天的贴现债。本期国债竞争性 招标面值总额600亿元,进行甲类成员追加投标。本期国债发行价格通过竞争性招标确定,以低于票面 金额的价格贴现发行。本期国债自2025年12月25日开始计息,于2026年6月25日(节假日顺延)按面值 偿还。招标时间为2025年12月24日上午10:35至11:35。 市场监管总局出台新规:压实食品销售连锁企业食品安全主体责任 上海市新增12款已完成 ...
昊海生科控股股东被罚;诺和诺德减肥药口服片在美获批
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-23 23:54
这里是《21健讯Daily》,欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件! 政策动向 《中药饮片追溯码编码规则》公开征求意见 12月23日,据国家医保局官微,为积极推动药品全品种生产流通使用过程追溯和药品追溯码在医疗保障 领域的全流程、全量采集和全场景应用,加快推进中药饮片纳入全国统一药品追溯体系、实现"一物一 码、全程可溯",国家医保局遵循"唯一性、通用性、实用性、可扩展性"原则,研究形成《中药饮片追 溯码编码规则》。现面向社会公开征求意见,欢迎公众围绕《中药饮片追溯码编码规则(征求意见 稿)》的编码结构、关键信息、追溯衔接、技术适配、实施落地等方面提出宝贵意见建议,以书面或电 子邮件形式反馈我局,意见反馈截止时间为2026年1月6日18:00。 《互联网药品医疗器械信息服务备案管理规定》发布 12月22日,国家药监局发布《互联网药品医疗器械信息服务备案管理规定》,自发布之日起施行。《规 定》明确了互联网药品医疗器械信息服务备案的内容、办理条件、工作程序、所需资料等相关事项。 12月23日,太极集团(600129.SH)公告称,公司全资子公司太极集团重庆涪陵制药厂有限公司持有参股 公司重庆 ...
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
Ge Long Hui A P P· 2025-12-23 09:23
该产品此前通过了世界卫生组织预认证的现场检查,截至本公告披露日,该产品的药品主文件 (DMF)审评也已通过,现已完全通过世界卫生组织预认证。 格隆汇12月23日丨联环药业(600513.SH)公布,公司收到世界卫生组织(WHO)通知,公司原料药产品左 炔诺孕酮(APIMF484,WHOAPI-484)(以下简称"该产品")通过世界卫生组织的预认证(PQ)。世界 卫生组织已经正式将该产品列入国际组织及公立机构采购范围。 ...
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
Zheng Quan Shi Bao Wang· 2025-12-23 09:23
另外,公司控股子公司常乐制药近日收到国家药监局核准签发的关于硫酸阿托品注射液《药品补充申请 批准通知书》,此次申请内容包括:增加1ml: 0.5mg规格;仿制药质量和疗效一致性评价。 人民财讯12月23日电,联环药业(600513)12月23日公告,公司收到世界卫生组织通知,公司原料药产品 左炔诺孕酮通过世界卫生组织的预认证。世界卫生组织已经正式将该产品列入国际组织及公立机构采购 范围。 转自:证券时报 ...
联环药业:公司原料药产品左炔诺孕酮通过世界卫生组织预认证
Mei Ri Jing Ji Xin Wen· 2025-12-23 09:13
每经AI快讯,12月23日,联环药业(600513)(600513.SH)公告称,公司收到世界卫生组织通知,公司 原料药产品左炔诺孕酮通过世界卫生组织的预认证。该产品此前已通过世界卫生组织预认证的现场检 查,且药品主文件(DMF)审评也已通过,现已完全通过世界卫生组织预认证。本次通过预认证不会对公 司当期经营业绩产生重大影响,未来产品销售订单存在不确定性。 ...
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
Core Points - The company received notification from the World Health Organization (WHO) regarding the successful closure of the on-site inspection for its active pharmaceutical ingredient, Levonorgestrel (APIMF484, WHOAPI-484) [1] - The inspection results indicate that the company's production line complies with WHO Good Manufacturing Practice (GMP) standards, which is beneficial for maintaining stable product quality and production capacity to meet market demand [1] - The successful WHO pre-certification inspection is not expected to have a significant impact on the company's recent performance [1]
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
Core Viewpoint - The company, Lianhuan Pharmaceutical, has successfully passed the World Health Organization's (WHO) pre-certification inspection for its active pharmaceutical ingredient, Levonorgestrel, indicating compliance with Good Manufacturing Practice (GMP) standards [1] Group 1: Company Performance - The successful completion of the WHO inspection demonstrates that the company's production line meets GMP requirements, which is crucial for maintaining stable product quality [1] - The inspection results are expected to support the company's ability to sustain stable production capacity to meet market demand for related pharmaceuticals [1] Group 2: Market Impact - The passing of the WHO pre-certification inspection is not anticipated to have a significant impact on the company's recent performance [1]
联环药业:目前已有6个创新药 其中1个进入 III 期
Zheng Quan Shi Bao Wang· 2025-06-10 13:19
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]