SHANDONG XINHUA Announces Successful Generic Drug Consistency Evaluation for Phenobarbital Tablets

Stock News05-18

SHANDONG XINHUA has issued an announcement stating that the company recently received the "Drug Supplement Application Approval Notice" for Phenobarbital Tablets issued by the National Medical Products Administration, signifying that the product has passed the consistency evaluation for generic drug quality and efficacy. In May 2025, the company submitted the consistency evaluation application materials for Phenobarbital Tablets to the Center for Drug Evaluation of the NMPA, which were accepted. The approval notice was obtained in May 2026, with the review conclusion confirming that the product passed the consistency evaluation for generic drug quality and efficacy. This product is primarily used to treat anxiety, insomnia (for patients with short sleep duration and early awakening), and epilepsy, serving as a medication for grand mal and partial seizures. It is listed as a Class A variety in both the "National Essential Drugs List" and the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2025)". According to relevant statistical data, the sales of Phenobarbital in China's public medical institutions in 2025 amounted to approximately RMB 220 million.

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