Core Viewpoint - The company, Stone Four Pharmaceutical Group, has received 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 obtain such approvals for these products [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's Urapidil and Nicardipine raw materials have been approved by the National Medical Products Administration for use in the registered formulations [1] - The company has also received 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 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.HK)旗下三个产品获药品生产注册批件