Core Viewpoint - The company has received production registration approvals from the National Medical Products Administration of China for two pharmaceutical products, marking a significant achievement as the first domestic enterprise to obtain such approvals for these drugs [1] Group 1: Product Approvals - The company has obtained production registration for Urapidil sustained-release capsules (30mg) and Nicardipine hydrochloride sodium injection (200ml), both classified as Category 3 chemical drugs, which are considered to 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 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 also obtained production registration for Butylscopolamine injection (2ml), classified as a Category 4 chemical drug, which is also considered to have passed the consistency evaluation [1] - Butylscopolamine injection is primarily used for treating smooth muscle spasms related to biliary diseases and urinary system diseases, and can also be used as an adjunct treatment for gastrointestinal spasms and to relieve dysmenorrhea [1]
石四药集团已取得乌拉地尔缓释胶囊、盐酸尼卡地平氯化钠注射液及盐酸屈他维林注射液的药品生产注册批件