Shijiazhuang Sihua Pharmaceutical Group’s two specifications of pitavastatin calcium tablets have been approved.
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Time:2023-07-05
On July 4, Shijiazhuang No.4 Pharmaceutical Group obtained drug production registration approvals from the National Medical Products Administration for two specifications—1mg and 2mg—of Pivastatin Calcium Tablets, Class 4 chemical drugs, which are deemed to have passed the consistency evaluation. As of now, the Group has 52 varieties comprising 69 specifications that have either passed or been deemed to have passed the national generic drug quality and efficacy consistency evaluation.
On July 4, Shijiazhuang Fourth Pharmaceutical Group’s Class 4 chemical drug—Pitavastatin Calcium Tablets in two strengths, 1 mg and 2 mg—obtained the Drug Production Registration Approval from the National Medical Products Administration and is deemed to have passed the Consistency Evaluation. As of now, the Group has 52 varieties comprising 69 specifications of products that have either passed or been deemed to have passed the National Generic Drug Quality and Efficacy Consistency Evaluation.
It is reported that pitavastatin calcium tablets are primarily used for hypercholesterolemia and familial hypercholesterolemia.
Last May, the active pharmaceutical ingredient—pitavastatin calcium—developed and submitted by Hebei Guangxiang Pharmaceutical Co., Ltd. of the Group received approval from the National Medical Products Administration, allowing it to be officially used in marketed dosage forms. The approval of pitavastatin calcium tablets will play a positive role in further enriching and perfecting the product portfolio of this drug category, enhancing its market competitiveness, and accelerating the implementation of Shijiazhuang Fourth Pharmaceutical Group’s “API + Finished Dosage Form” strategy.
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