山东新华制药股份(00719)获间苯三酚注射液药品注册证书
智通财经网·2025-12-29 08:45

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of its Isopropylphenol Injection, marking a significant milestone for the company in expanding its product offerings in the pharmaceutical market [1] Group 1: Product Approval and Registration - The company submitted the registration application for Isopropylphenol Injection to the Center for Drug Evaluation (CDE) in July 2024, which was accepted [1] - The product received its registration certificate in December 2025, with the evaluation conclusion being approval for registration [1] Group 2: Product Indications - Isopropylphenol Injection is indicated for the treatment of acute spasmodic pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1] Group 3: Market Potential - The product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The estimated sales revenue for Isopropylphenol Injection in Chinese public medical institutions is approximately RMB 900 million in 2024 [1]

XINHUA PHARM-山东新华制药股份(00719)获间苯三酚注射液药品注册证书 - Reportify