盐酸屈他维林注射液(2ml)

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石四药集团午后涨近14% 旗下三种新药获批生产注册批件 花旗称公司受益药品集采
Zhi Tong Cai Jing· 2025-09-05 07:04
石四药集团(02005)午后涨近14%,截至发稿,涨13.85%,报3.37港元,成交额2.22亿港元。 消息面上,石四药集团公告,集团已取得中国国家药监局有关乌拉地尔缓释胶囊(30mg)及盐酸尼卡地平 氯化钠注射液(200ml)的药品生产注册批件,均属于化学药品第3类,视同通过一致性评价。以上两个产 品都是国内企业首家获批。此外,集团已取得国家药监局有关盐酸屈他维林注射液(2ml)的药品生产注 册批件,属于化学药品第4类,视同通过一致性评价。 花旗发布研报称,在第11轮药品集采中,石四药集团有包括溴己新在内的11种药品,占2024年预计销售 约1.5%,认为石四药集团很大机会赢得腹膜透析液并续约其他产品。花旗认为集团是仿制药企业中的 赢家,也是药品集采最大受益者。 ...
石四药集团旗下三个产品获药品生产注册批件
Zheng Quan Shi Bao Wang· 2025-09-01 05:00
Core Viewpoint - The company Shijiazhuang Fourth Pharmaceutical Group has received approval from the National Medical Products Administration to produce three new pharmaceutical products, marking significant advancements in its product offerings [1] Group 1: Product Approvals - The approved products include Urapidil sustained-release capsules (30mg), Nicardipine hydrochloride sodium chloride injection (200ml), and Clonidine hydrochloride injection (2ml) [1] - Urapidil sustained-release capsules and Nicardipine hydrochloride sodium chloride injection are the first of their kind to be approved in China, indicating a competitive edge in the market [1] - Clonidine hydrochloride injection is also considered to have passed the consistency evaluation, categorized as a Class 4 chemical drug [1]
石四药集团(02005)已取得乌拉地尔缓释胶囊(30mg)、盐酸尼卡地平氯化钠注射液(200ml)及盐酸屈他维林注射液(2ml)的药品生产注册批件
智通财经网· 2025-09-01 04:33
Core Viewpoint - The company has obtained production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, marking a significant achievement as they are the first domestic enterprises to receive such approvals [1] Group 1: Product Approvals - The company has received production registration for Urapidil sustained-release capsules (30mg) and Nicardipine hydrochloride sodium injection (200ml), both classified as Category 3 chemical drugs, indicating they have passed the consistency evaluation [1] - Urapidil sustained-release capsules are primarily used for treating primary hypertension, renal hypertension, hypertension caused by pheochromocytoma, and urinary disorders associated with prostatic hyperplasia [1] - Nicardipine hydrochloride sodium injection is mainly used for the emergency management of abnormal hypertension during surgery and hypertensive emergencies [1] Group 2: Raw Material Approvals - The company has also received approval for the raw materials of Urapidil and Nicardipine hydrochloride, which have been registered with the National Medical Products Administration for use in marketed formulations [1] Group 3: Additional Product Approval - The company has obtained production registration for Butylscopolamine injection (2ml), classified as a Category 4 chemical drug, also indicating it has passed the consistency evaluation [1] - Butylscopolamine injection is used for treating smooth muscle spasms related to biliary diseases and urinary system diseases, and can also assist in treating smooth muscle spasms caused by gastrointestinal diseases and alleviate dysmenorrhea [1]