Shijiazhuang Sihua Pharmaceutical Group’s Two New Specialty APIs—Vonoprazan Fumarate and Dronedarone Hydrochloride—Have Been Approved


TIME:2024-12-16

【SUMMARY】 On December 13, fumarate of vonoprazan, developed and submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, and dronedarone hydrochloride, submitted by Hebei Guolong Pharmaceutical Co., Ltd., were both approved by the National Medical Products Administration and registered as active pharmaceutical ingredients for use in marketed dosage forms; notably, dronedarone hydrochloride marks the third such approval granted to a domestic enterprise. To date, the Group’s portfolio of API products has expanded to 66.

On December 13, fumarate of vonoprazan, developed and submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, and dronedarone hydrochloride, submitted by Hebei Guolong Pharmaceutical Co., Ltd., were both approved by the National Medical Products Administration and registered as active pharmaceutical ingredients for use in marketed dosage forms; notably, Hebei Guolong Pharmaceutical is the third domestic company to receive such approval. To date, the Group’s portfolio of API products has expanded to 66.

According to available information, vonoprazan fumarate is primarily used for the treatment of reflux esophagitis; dronedarone hydrochloride is an antiarrhythmic agent.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, aligned with national strategic development priorities, and actively pursued an integrated “API–formulation” business strategy. The company has strategically linked its innovation chain to the industrial value chain, while deepening the R&D of high-end, complex generic drugs and innovative pharmaceuticals. At the same time, in response to domestic and international market demands, it has vigorously advanced the development of specialty APIs and secured international certifications for its products, gradually establishing an innovative API development model that is led by specialty APIs and supported by bulk APIs. Currently, the proportion of specialty API projects in the group’s portfolio continues to grow, with 66 approved products and significantly accelerated commercialization, making this area a new highlight of the company’s innovation-driven growth.

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