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Shijiazhuang Sihua Pharmaceutical Group’s Ondansetron Hydrochloride Injection Approved
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发布时间：2024-05-27
【概要描述】
On May 27, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—ondansetron hydrochloride injection (4 mL: 8 mg and 2 mL: 4 mg)—received drug production registration approval from the National Medical Products Administration and is deemed to have passed the consistency evaluation. This marks the 33rd new product approved by the company so far this year. To date, the group has had a total of 113 specifications across 83 products either pass or be deemed to have passed the consistency evaluation.
On May 27, Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug—ondansetron hydrochloride injection (4 mL: 8 mg and 2 mL: 4 mg)—received drug production registration approval from the National Medical Products Administration and is deemed to have passed the bioequivalence evaluation. This marks the 33rd new product approved by the company so far this year. To date, the group has had a total of 113 dosage forms across 83 drug varieties either pass or be deemed to have passed the bioequivalence evaluation.
According to reports, ondansetron hydrochloride injection is primarily used to control nausea and vomiting induced by cancer chemotherapy and radiotherapy, as well as to prevent and treat postoperative nausea and vomiting.
Currently, the dosage forms of ondansetron hydrochloride available for sale in China mainly include tablets, capsules, orally disintegrating tablets, injectable solutions, and orodispersible films. According to data from Mene.net, sales of ondansetron hydrochloride have shown rapid growth in recent years, with a year-on-year increase of 20.80% in 2021—marking the first time annual sales exceeded RMB 1.2 billion—and a further increase of 14.24% in the first half of 2022, reaching RMB 676 million.
Previously, the group had already marketed formulations such as ondansetron hydrochloride capsules and ondansetron hydrochloride tablets (8 mg and 4 mg). The recent approval of ondansetron hydrochloride injection (4 mL: 8 mg and 2 mL: 4 mg) further diversifies the product portfolio for this active ingredient, which will positively contribute to meeting diverse clinical needs and enhancing the product’s market accessibility.
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Non-Commercial (Filing) – 2025-0091