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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
Shijiazhuang Sihua Pharmaceutical Group’s Ondansetron Hydrochloride Tablets and Epalrestat Tablets Have Been Approved
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发布时间：2023-10-26
【概要描述】
Recently, Shijiazhuang Sihua Pharmaceutical Group’s applications for two specifications—8 mg and 4 mg—of ondansetron hydrochloride tablets in Class 3 chemical drugs, as well as 50 mg of epalrestat tablets, were approved by the National Medical Products Administration for drug production registration and are deemed to have passed the consistency evaluation. Notably, the ondansetron hydrochloride tablets represent the third domestic manufacturer to receive such approval.
Recently, Shijiazhuang Sihua Pharmaceutical Group’s applications for two specifications of chemically synthesized Class 3 drugs—ondansetron hydrochloride tablets in 8 mg and 4 mg strengths, as well as epalrestat tablets in 50 mg strength—have been approved by the National Medical Products Administration for drug production registration and are deemed to have passed the consistency evaluation. Notably, the ondansetron hydrochloride tablets represent the third domestic manufacturer to receive such approval.
According to reports, ondansetron hydrochloride tablets are primarily indicated for the treatment of nausea and vomiting induced by postoperative care, cytotoxic chemotherapy, or radiotherapy, as well as for the prevention of postoperative nausea and vomiting; epalrestat tablets are mainly used for the treatment of diabetic neuropathy. In 2022, the Group’s epalrestat API was approved by the National Medical Products Administration and registered as an API intended for use in marketed dosage forms.
As we enter the fourth quarter, Shijiazhuang Sihua Pharmaceutical Group has been reporting one breakthrough after another in R&D and innovation: since October, it has secured approval for a total of eight new products, further optimizing its product portfolio. To date, the group has achieved bioequivalence for 62 drug varieties encompassing 81 dosage forms.
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