Nicorandil Tablets Approved for Shijiazhuang Sihua Pharmaceutical Group
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发布时间:2024-09-03
【概要描述】
On September 2, the Class 4 chemical drug nicorandil tablets submitted by Shijiazhuang Sihua Pharmaceutical Group received approval for drug production registration from the National Medical Products Administration and were deemed to have passed the consistency evaluation, making it the 65th new product approved so far this year.
On September 2, Nicorandil Tablets, a Class 4 chemical drug submitted by Shijiazhuang Sihua Pharmaceutical Group, received approval for drug production registration from the National Medical Products Administration and is deemed to have passed the consistency evaluation, making it the 65th new product approved so far this year.
According to available information, this product is primarily indicated for the treatment of angina pectoris. Prior to this, the group’s nicorandil API was successfully reclassified as “A” and approved at the end of 2023, while the lyophilized powder for injection formulation of nicorandil was also approved in March 2024 and is deemed to have passed the bioequivalence evaluation for generic drugs.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has aligned its strategies with national development priorities and cutting-edge market demands, leveraging innovation as the driving force to strategically develop an integrated API–formulation value chain. The company has vigorously promoted synergistic development between APIs and related formulations, continuously expanded its product portfolio, and enhanced the quality and efficiency of both formulation and API operations. To date, 103 drug varieties comprising 136 dosage forms have either passed or been deemed to have passed the bioequivalence evaluation for generic drugs.
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