Active Pharmaceutical Ingredient Development Accelerates Once Again: Shijiazhuang Sihua Pharmaceutical Group Receives Concurrent Approval for Two APIs—Alogliptin Benzoate and Betahistine Hydrochloride


发布时间:2024-07-17

【概要描述】 With a relentless drive to innovate, the company has achieved remarkable and inspiring results. On July 17, Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, received approval from the National Medical Products Administration for two active pharmaceutical ingredients—alogliptin benzoate and betahistine hydrochloride—enabling their registration as APIs for use in marketed dosage forms. Since the beginning of this year, the group has secured approval for 16 new specialty API products.
        With a relentless drive to innovate, the company has achieved remarkable and inspiring results. On July 17, Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, received approval from the National Medical Products Administration for two active pharmaceutical ingredients—alogliptin benzoate and betahistine hydrochloride—enabling their registration as APIs for use in marketed dosage forms. Since the beginning of this year, the group has secured approval for 16 new specialty API products.
According to available information, alogliptin benzoate is an antidiabetic agent primarily used for the treatment of type 2 diabetes. Betahistine hydrochloride is a vasodilator mainly indicated for the treatment of inner-ear vertigo (Meniere’s disease), as well as dizziness, lightheadedness, vomiting, and tinnitus caused by cerebral ischemia.
Perseverance in action ensures a promising future. In recent years, Shijiazhuang Sihua Pharmaceutical Group has adopted a multi-pronged approach to continuously optimize its product portfolio, accelerate the R&D and commercialization of new API products, and emphasize the integrated development model of “APIs plus formulations.” At the same time, the company has intensified its two-way market-development efforts—both by expanding its global presence and by attracting international expertise—thereby strengthening its supply relationships with formulation manufacturers, better meeting domestic market demand, and steadily enhancing the resilience and vitality of its API business. To date, the company boasts 62 bulk and specialty API products, with an increasingly robust product pipeline that provides substantial support for its sustainable growth.
 

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