Core Viewpoint - Shanghai Pharmaceuticals has received a drug registration certificate from the Health Sciences Authority of Singapore for its rivaroxaban tablets, allowing the product to be marketed in Singapore [1][4]. Group 1: Drug Basic Information - Drug Name: Rivaroxaban Tablets - Dosage Forms: Tablets - Specifications: 10mg, 15mg, 20mg - Registration Classification: Chemical Generic Drug - Manufacturer: Changzhou Pharmaceutical Factory Co., Ltd. - Registration Numbers: 10mg: SIN17463P, 15mg: SIN17462P, 20mg: SIN17461P [2]. Group 2: Drug Indications - Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment and prevention of deep vein thrombosis (DVT); for the treatment of pulmonary embolism (PE); and for the prevention of venous thromboembolism (VTE) in acutely ill patients [2]. Group 3: Market Competition - As of the announcement date, there are six other approved manufacturers in Singapore for rivaroxaban tablets, with BAYER being the main seller. The total sales amount for the three specifications (10mg, 15mg, 20mg) in the Singapore market is projected to be $8 million in 2024 [3]. Group 4: Impact on the Company - The approval of rivaroxaban tablets for sale in Singapore is expected to positively impact the company's efforts to expand into overseas markets and accumulate valuable experience [4].
上海医药集团股份有限公司关于利伐沙班片获得新加坡药品注册证书的公告