SHANDONG XINHUA (00719) Unit Secures Drug Registration Certificate for Ibuprofen Granules

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SHANDONG XINHUA PHARMACEUTICAL (00719) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Ibuprofen Granules from the National Medical Products Administration. In December 2023, Xinda Pharmaceutical submitted the application for market approval of Ibuprofen Granules to the Center for Drug Evaluation (CDE) of the NMPA, which was accepted. The certificate was granted in March 2026, with the review conclusion being approval for registration. The product is indicated for the relief of mild to moderate pain, such as headaches, joint pain, migraines, toothaches, muscle aches, nerve pain, and menstrual cramps, as well as for reducing fever caused by the common cold or influenza. Ibuprofen Granules are listed as a Category B drug in the National Reimbursement Drug List (2025 edition). According to relevant statistics, sales of ibuprofen-related formulations in China's public medical institutions reached approximately RMB 4.4 billion in 2024.

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