Stringing Beads into a Chain: Shijiazhuang Sihua Pharmaceutical Group’s Magnesium Sulfate Injection (10 ml: 2.5 g) Receives Approval as an Expanded-Indication Product
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发布时间:2026-03-23
【概要描述】
On March 23, Shijiazhuang Sihua Pharmaceutical Group received approval from the National Medical Products Administration for the registration of an expanded indication for its Class 3 chemical drug—magnesium sulfate injection (10 mL: 2.5 g). This marks the group’s seventh new dosage-form product approved so far this year.
On March 23, Shijiazhuang Sihua Pharmaceutical Group received approval from the National Medical Products Administration for the registration of its Class 3 chemical drug—magnesium sulfate injection (10 mL: 2.5 g)—as an expanded indication product. This marks the group’s seventh new dosage-form product approved so far this year.
According to available information, magnesium sulfate injection can be used as an anticonvulsant for gestational hypertension to lower blood pressure and treat preeclampsia and eclampsia.
The newly approved magnesium sulfate injection (10 mL: 2.5 g) complements the Group’s previously approved magnesium sulfate injection products in four other strengths—20 mL: 10 g, 10 mL: 5 g, 2 mL: 1 g, and 5 mL: 2.5 g—thereby further enriching the Group’s portfolio of finished dosage forms and providing clinicians with a more diversified range of therapeutic options. To date, the Group has had a total of 171 drug varieties comprising 223 product specifications that have either passed or are deemed to have passed the bioequivalence and therapeutic equivalence assessment for generic drugs, continuously enhancing both product supply capacity and clinical accessibility.
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