In July 2022, Zhejiang Asen Pharmaceutical Co., Ltd. received the Supplemental Drug Application Approval Notice (Notice No.: 2022B03068) for Progesterone Soft Capsules issued by the National Medical Products Administration (NMPA), marking the product as the first in China to pass the Consistency Evaluation of the Quality and Efficacy of Generic Drugs.
Progesterone Soft Capsules are indicated for threatened abortion and habitual abortion, premenstrual tension syndrome, anovulatory dysfunctional uterine bleeding and anovulatory amenorrhea, as well as for combination therapy with estrogen in the treatment of menopausal syndrome. Since its market approval in 2003, the product has been highly recognized by physicians and patients through years of clinical use, and was honored with the “Excellent Product Brand in Gynecological Drugs of China’s Chemical Pharmaceutical Industry” award at the China Chemical Pharmaceutical Industry Annual Summit in 2014.
This successful Consistency Evaluation strongly demonstrates that the product has achieved quality and efficacy equivalent to those of the originator product. This achievement will benefit a large number of patients and also provide valuable experience for the company’s subsequent generic drug Consistency Evaluation projects.
Over the years, Zhejiang Asen has always adhered to the corporate mission of "Creating Wealth, Fulfiling Employees, and Benefiting Society ", continuously increasing R&D investments in new products and processes. With full-staff and full-process commitment to drug quality, the company enriches its product portfolio and improves product quality. In the future, while maintaining a strong focus on drug R&D, Zhejiang Asen will continue to solidify the competitive advantages of this product, enhance brand influence, and strive toward the vision of becoming “a leading pharmaceutical and healthcare enterprise in China, and an internationally renowned one.”