Shanghai Pharma subsidiary's Tramadol injection gets consistency evaluation approval

Shanghai Pharmaceuticals Holding Co., Ltd. announced its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for its Tramadol Hydrochloride Injection. The approval confirms the drug has passed the generic drug quality and efficacy consistency evaluation. This approval, number 2025B05705, was issued via a "Drug Supplementary Application Approval Notice." The Tramadol Hydrochloride Injection, used for moderate to severe pain, was originally developed by Grünenthal GmbH.

Shanghai Hefeng submitted its supplementary application for the consistency evaluation in August 2024. The research and development expenses for this evaluation amounted to approximately RMB 1.52 million. This achievement is expected to expand the drug's market share and enhance competitiveness, while also providing experience for the company's future consistency evaluation efforts.

IQVIA database figures indicate that the hospital procurement value of Tramadol Hydrochloride Injection in mainland China reached RMB 61,453 million in 2024. The company notes that passing the consistency evaluation can lead to greater support in medical insurance payments and hospital procurement. However, potential sales may not meet expectations due to uncertainties in national policies and market conditions.