Shanghai Pharma subsidiary now holds amisulpride tablets marketing authorization

Shanghai Pharmaceuticals Holding Co., Ltd. (Shanghai Pharma) announced that its subsidiary, Shanghai No.1 Pharmaceutical Co., Ltd. (Shanghai No.1), has been approved by the National Medical Products Administration (NMPA) to become the marketing authorization holder for amisulpride orally disintegrating tablets. This approval transfers the marketing authorization from Shanghai Zhenzheng Pharmaceutical Technology Co., Ltd. to Shanghai No.1.

Amisulpride orally disintegrating tablets, a modified formulation of amisulpride tablets, are indicated for the treatment of adult schizophrenia. Shanghai No.1 submitted its marketing authorization change application in September 2025. Shanghai Pharma has invested approximately RMB 3,150万元 in this product to date.

As of the announcement date, no other companies in China market amisulpride orally disintegrating tablets. According to IQVIA data, the hospital procurement value for amisulpride oral preparations in 2024 was RMB 16,841万元. This move is expected to enhance Shanghai No.1's product line and market competitiveness. However, the company also noted potential sales performance risks due to uncertainties in national policies and market conditions.