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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
Two Specifications of Pitavastatin Calcium Tablets Approved for Shijiazhuang Sihua Pharmaceutical Group
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发布时间：2023-07-05
【概要描述】
On July 4, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug application for pitavastatin calcium tablets in 1 mg and 2 mg strengths received approval for drug manufacturing registration from the National Medical Products Administration, and the products are deemed to have passed the bioequivalence evaluation. To date, the Group has had a total of 52 drug varieties comprising 69 dosage forms that have either passed or are deemed to have passed the national bioequivalence evaluation for generic drugs.
On July 4, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug application for pitavastatin calcium tablets in 1 mg and 2 mg strengths received approval for drug production registration from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation. To date, the Group has had a total of 52 drug varieties comprising 69 dosage forms that have either passed or are deemed to have passed the national bioequivalence evaluation for generic drugs.
According to reports, pitavastatin calcium tablets are primarily indicated for hypercholesterolemia and familial hypercholesterolemia.
In May of last year, the pitavastatin calcium API developed and submitted for approval by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of the Group, was approved by the National Medical Products Administration, thereby becoming eligible for use in marketed dosage forms. The recent approval of pitavastatin calcium tablets will play a positive role in further enriching and optimizing the product portfolio of this active ingredient, enhancing market competitiveness, and accelerating the implementation of Shijiazhuang Sihua Pharmaceutical Group’s “API-plus-formulation” strategy.
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