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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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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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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
Good News! Shijiazhuang Sihua Pharmaceutical Group’s Tinidazole Tablets and Ornidazole Tablets Approved on the Same Day
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发布时间：2023-10-11
【概要描述】
On October 11, Shijiazhuang Sihua Pharmaceutical Group announced another significant breakthrough in innovative R&D: the group’s tinidazole tablets (0.5 g) and ornidazole tablets (0.5 g) both received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the bioequivalence evaluation. To date, the group has a total of 58 drug varieties comprising 76 dosage forms that have either passed or are deemed to have passed the bioequivalence evaluation. Since the beginning of this year, the group has been approved for a total of 48 new products, maintaining a leading position in R&D efficiency within the industry.
On October 11, Shijiazhuang Sihua Pharmaceutical Group announced another significant achievement in innovative R&D: the group’s tinidazole tablets (0.5 g) and ornidazole tablets (0.5 g) both received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation. To date, the group has a total of 58 drug varieties comprising 76 specifications that have either passed or are deemed to have passed the consistency evaluation. Since the beginning of this year, the group has been approved for a total of 48 new products, maintaining a leading position in R&D efficiency within the industry.
According to reports, both of the newly approved products fall under Category 3 of chemical drugs. Tinidazole tablets are primarily indicated for the treatment of trichomoniasis, giardiasis, amebiasis, bacterial vaginosis, Helicobacter pylori–associated duodenal ulcers, anaerobic bacterial infections, and the prevention of postoperative infections caused by anaerobic bacteria. Ornidazole tablets are mainly used for the treatment of amebiasis, urogenital trichomoniasis, and Giardia lamblia infection, as well as infections caused by anaerobic bacteria that are sensitive to ornidazole, and for the prevention of surgical-site infections due to susceptible anaerobic bacteria.
Previously, the Group’s active pharmaceutical ingredients—ornidazole and tinidazole—were successively approved by the National Medical Products Administration and registered as APIs used in marketed dosage forms. The recent approval of ornidazole tablets and tinidazole tablets will play a positive role in advancing the orderly implementation of the Group’s integrated “API–dosage form” strategy and in upgrading its antimicrobial product portfolio.
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