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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Guolong Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Amipridine API
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发布时间：2025-08-14
【概要描述】
On August 13, the ampyrin API developed and submitted for approval by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms, making it the first such API to be approved in China.
On August 13, the ampyrine API developed and submitted for approval by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API intended for use in marketed dosage forms, making it the first such API to receive approval in China.
According to reports, ampyrin is a potassium channel blocker primarily used to improve walking speed in certain adults with multiple sclerosis.
The Group continues to advance the development and strategic positioning of specialty APIs. Since the beginning of this year, it has obtained approval for 13 new API varieties, including five approved for Guolong Pharmaceutical. To date, the Group’s portfolio encompasses 80 bulk and specialty APIs, with the integrated “API-plus-formulation” development model increasingly demonstrating its competitive advantages.
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Non-Commercial (Filing) – 2025-0091