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Two New Specifications of Vonoprazan Fumarate Tablets from Shijiazhuang Sihua Pharmaceutical Group Have Been Approved
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发布时间：2025-01-08
【概要描述】
On January 8, two dosage forms of Fesoterodine Fumarate Tablets (10 mg and 20 mg), classified as Category 4 chemical drugs and developed by Shijiazhuang Sihua Pharmaceutical Group, were approved for registration by the National Medical Products Administration and are deemed to have passed the bioequivalence evaluation for generic drugs. This marks the second new dosage-form product approved for the Group since the beginning of 2025, bringing the total number of products that have passed the evaluation to 151 specifications across 114 varieties.
On January 8, two specifications of Fumaric Acid Vonoprazan Tablets (10 mg and 20 mg), a Class 4 chemical drug developed by Shijiazhuang Sihua Pharmaceutical Group, were approved for registration by the National Medical Products Administration and are deemed to have passed the bioequivalence evaluation for generic drugs. This marks the second new dosage form approved for the Group since the beginning of 2025, bringing the total number of products that have passed the evaluation to 151 specifications across 114 varieties.
According to available information, vonoprazan fumarate tablets are primarily indicated for the treatment of acid-related gastrointestinal disorders, including reflux esophagitis (RE), gastric ulcers, and duodenal ulcers.
According to data from MeneNet, sales of vonoprazan fumarate tablets in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 612 million in 2023, with sales reaching RMB 368 million in the first half of 2024.
Previously, on December 13, 2024, the active pharmaceutical ingredient vorapaxar fumarate developed and submitted for approval by Hebei Guangxiang Pharmaceutical Co., Ltd. of the Group was approved by the National Medical Products Administration and registered as an API intended for use in marketed dosage forms. This integrated “API-plus-formulation” development model opens up new opportunities for further enhancing the market accessibility of formulation products.
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Non-Commercial (Filing) – 2025-0091