Shanghai Pharmaceuticals Receives Thai FDA Approval for Pregabalin Capsules

Shanghai Pharmaceuticals Receives Thai FDA Approval for Pregabalin Capsules

China-based Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that it has received marketing approval from the Thai Food and Drug Administration (TFDA) for pregabalin capsules in 50mg, 75mg, and 150mg strengths.

Product and Manufacturer Details
The pregabalin capsules are manufactured by the company’s subsidiary Changzhou Pharmaceutical Factory Co. Ltd. The product is indicated for postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for epilepsy.

Market Context and Business Impact
The product was initially approved in the United States in July 2021. Market data shows that Thailand’s pregabalin capsule market reached total sales of USD 46.63 million across all strengths in 2024. With 24 competitors in the market, including Viatris, Sandoz, and Biolab, this approval will facilitate Shanghai Pharmaceuticals’ further business expansion in the Southeast Asian market.-Fineline Info & Tech