Zheng Quan Zhi Xing·2025-06-19 08:22Core Viewpoint - Shanghai Pharmaceuticals has received the drug registration certificate for Pregabalin capsules from the Thai Food and Drug Administration, allowing the product to be marketed in Thailand [1][2]. Group 1: Drug Information - Drug Name: Pregabalin Capsules - Dosage Forms: Capsule - Specifications: 50mg, 75mg, 150mg - Registration Category: Chemical Generic Drug - Manufacturer: Changzhou Pharmaceutical Factory Co., Ltd. [1] - Registration Numbers: 50mg: 1C 97/68 (NG); 75mg: 1C 98/68 (NG); 150mg: 1C 99/68 (NG) [1]. Group 2: Indications - Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, and neuropathic pain due to spinal cord injury, as well as for adjunctive treatment of epilepsy [1]. Group 3: Market Competition - As of the announcement date, Pregabalin capsules in Thailand face competition from 24 other sellers, including VIATRIS, SANDOZ, and BIOLAB [2]. - According to IQVIA data, the total market for Pregabalin capsules in Thailand is projected for 2024 [2]. Group 4: Financial Investment - The company has invested approximately RMB 2.19 million in research and development for the product's market entry in Southeast Asia, including Thailand, Singapore, Malaysia, and the Philippines [2]. Group 5: Impact on Company - The approval of Pregabalin capsules in three specifications (50mg, 75mg, 150mg) signifies the company's qualification to sell the drug in Thailand, positively impacting its overseas market expansion and accumulating valuable experience [2].