Good News Abounds: Shijiazhuang Sihua Pharmaceutical Group’s Specialty API Rosuvastatin Calcium Approved


TIME:2022-06-23

【SUMMARY】 On June 23, the rosuvastatin calcium API submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms.
On June 23, the rosuvastatin calcium API submitted by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an API for use in marketed dosage forms. This marks the eighth specialty API production approval that Shijiazhuang Sihua Pharmaceutical Group has obtained this year since implementing its “API-plus-formulation” product strategy.
According to available information, rosuvastatin calcium is primarily indicated for the treatment of primary hypercholesterolemia or mixed dyslipidemia. Previously, the Group had obtained drug production registration approvals from the National Medical Products Administration for two dosage strengths of rosuvastatin calcium tablets—5 mg and 10 mg.
Over the past two years, Shijiazhuang Sihua Pharmaceutical has aligned its innovation strategy with the industrial value chain, with R&D investment accounting for nearly 10% of its core business revenue. Through continuous optimization of its research systems and mechanisms and robust talent development, the company has entered a concentrated “harvest period” of scientific and technological innovation, effectively accelerating its transition to innovative growth. To date this year, a total of 21 new formulation and active pharmaceutical ingredient projects have been approved, averaging more than three per month. The company’s output and R&D efficiency in developing specialty generic drugs and APIs rank among the highest in the domestic industry, providing strong impetus for its move up the value chain.

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