山东新华制药股份获得枸橼酸西地那非口崩片药品注册证书
Zhi Tong Cai Jing·2025-09-16 08:56

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Sildenafil Citrate Orally Disintegrating Tablets, which is expected to enhance the company's market competitiveness and open new market opportunities [1]. Company Summary - The company submitted the registration application for Sildenafil Citrate Orally Disintegrating Tablets to the Center for Drug Evaluation (CDE) in April 2024, and the application was accepted [1]. - The drug received its registration certificate in September 2025, with the evaluation conclusion being approval for registration [1]. - The product is indicated for the treatment of erectile dysfunction, a market that generated approximately RMB 5.2 billion in sales for related formulations in public medical institutions in China in 2024 [1]. Industry Summary - The approval of Sildenafil Citrate Orally Disintegrating Tablets is expected to contribute positively to the market landscape for erectile dysfunction treatments in China [1]. - The significant sales figure of RMB 5.2 billion in 2024 indicates a robust demand for erectile dysfunction medications within the public healthcare sector [1].