山东新华制药股份获间苯三酚注射液药品注册证书

Group 1 - The core point of the article is that Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of its injection product, Isopropylphenol [1] - The product is indicated for the treatment of acute spasmodic pain caused by digestive system and biliary dysfunction, as well as acute spasmodic pain in the urinary tract, bladder, and kidney, and gynecological spasmodic pain [1] - 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] Group 2 - In July 2024, the company submitted the registration application for the domestic production of Isopropylphenol injection, which was accepted by the National Medical Products Administration [1] - The product received its registration certificate in December 2025, with the review conclusion being approval for registration [1] - The estimated sales revenue for Isopropylphenol injection in Chinese public medical institutions is approximately RMB 900 million in 2024 [1]