上海医药:普瑞巴林胶囊获新加坡药品注册证书
Xin Lang Cai Jing·2026-01-23 07:38

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received a drug registration certificate from the Health Sciences Authority (HSA) of Singapore for the launch of Pregabalin capsules, indicating a significant milestone in the company's product portfolio expansion in Southeast Asia [1] Group 1: Product Approval and Indications - Pregabalin capsules are approved for the treatment of postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunctive treatment for epilepsy [1] - The drug development for Pregabalin capsules was completed by Changzhou Pharmaceutical Factory in October 2019, and it received approval from the U.S. Food and Drug Administration (FDA) in July 2021 [1] Group 2: Market Expansion and Investment - The approval in Singapore follows the drug's approval in Thailand in June 2025, indicating a strategic focus on expanding into Southeast Asian markets, including Thailand, Singapore, Malaysia, and the Philippines [1] - The company has invested approximately RMB 2.19 million in research and development for this drug in the Southeast Asian market as of the date of the announcement [1]