In June 2023, Zhejiang Asen Pharmaceutical Co., Ltd. received the "Supplemental Drug Application Approval Notice" (Notice No.: 2023B03185) for Ornidazole Tablets from the National Medical Products Administration (NMPA). This marks another product of the company to successfully pass the Consistency Evaluation, following the first-in-China approval of Progesterone Soft Capsules in 2022.
Ornidazole, a derivative of 5-nitroimidazole, is a third-generation nitroimidazole drugs. It is a synthetic anti-anaerobic agent characterized by a broad spectrum of anti-anaerobic activity, strong antibacterial efficacy, and mild side effects. Developed after metronidazole and tinidazole, ornidazole is a new drug offering high efficacy, short treatment duration, and good tolerability. It has potent anti-anaerobic and anti-protozoal (e.g., against trichomonas) effects, and is widely used in the treatment of various infections caused by anaerobic bacteria, Entamoeba histolytica, Giardia lamblia, Trichomonas, and others.
Generic Drug Consistency Evaluation is a scientific approach to assessing generic drugs, controlling drug quality at the source, and improving drug quality and efficacy. According to relevant national policies, products that pass the Consistency Evaluation are eligible for certain support in drug bidding, medical insurance reimbursement, and other aspects, which will have a positive impact on the sales of the product.
The successful Consistency Evaluation of Ornidazole Tablets demonstrates that the company’s product has achieved quality and efficacy equivalent to the originator product, significantly reducing patients’ medication expenses and lowering medical insurance expenditures. In the future, Zhejiang Asen will continue to adhere to its corporate mission of "Creating Wealth, Fulfiling Employees, and Benefiting Society ", strictly comply with GMP standards for pharmaceutical production, improve and enhance product quality, and make positive contributions to human health.