Butylphthalide API Approved by Shijiazhuang Sihua Pharmaceutical Group


发布时间:2024-06-11

【概要描述】 Good news has spread rapidly, inspiring great enthusiasm. On June 7, dibutylphthalide, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the 10th API approved for the group so far this year.
Good news has been pouring in, inspiring great enthusiasm. On June 7, dibutylphthalide, submitted by Hebei Guangxiang Pharmaceutical Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the group’s tenth API approval so far this year.
According to available information, butylphthalide is primarily used for the treatment of mild to moderate ischemic stroke. Data from MeneNet show that, at the end-user level in China’s urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics—collectively referred to as China’s public medical institutions—the total sales of butylphthalide formulations remained above RMB 6 billion from 2020 to 2022, making it the best-selling domestically developed original chemical drug. In the first half of 2023, butylphthalide ranked as the top-selling product in the central nervous system pharmaceutical market. The recent approval of the group’s butylphthalide API will provide greater flexibility and more options for companies engaged in the production of related formulations.
Currently, Shijiazhuang Sihua Pharmaceutical Group boasts 56 bulk and specialty active pharmaceutical ingredients, with a robust pipeline of innovative R&D achievements that are steadily translating into marketable products. This has significantly accelerated the company’s integrated “API-plus-formulation” development strategy.

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