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]
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