上海医药集团股份有限公司关于普瑞巴林胶囊获得菲律宾药品注册证书的公告

Group 1 - The core point of the announcement is that Shanghai Pharmaceuticals has received a drug registration certificate from the Philippines Food and Drug Administration for its Pregabalin capsules, allowing the product to be marketed in the Philippines [1][4]. Group 2 - The drug is named Pregabalin capsules, available in dosages of 50mg, 75mg, and 150mg, and is classified as a chemical generic drug [1]. - Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunctive treatment for epilepsy [1]. Group 3 - The development of Pregabalin capsules was completed by Changzhou Pharmaceutical Factory in October 2019, and the product received FDA approval in the United States in July 2021. It also obtained drug registration certificates in Thailand in June 2025 and Singapore in January 2026 [2]. Group 4 - As of the end of 2024, there are 19 distributors of Pregabalin capsules in the Philippines, including UNILAB, VIATRIS INC, and NATRAPHARM. The total sales amount for the three dosages in the Philippines market is projected to be $13.37 million [3].