Continuous Launch of New Active Pharmaceutical Ingredients! Shijiazhuang Sihua Pharmaceutical Group’s Guolong Pharmaceutical Receives Approval for Finafene Active Pharmaceutical Ingredient


发布时间:2025-12-05

【概要描述】 On December 5, finerenone, developed by Hebei Guolong Pharmaceutical Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the second such approval in China. To date, the Group holds 91 API varieties, 42 of which are manufactured by Guolong Pharmaceutical.
On December 5, finerenone, developed by Hebei Guolong Pharmaceutical Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group, was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This marks the second such approval in China. To date, the Group holds 91 API varieties, 42 of which are under Guolong Pharmaceutical.
According to available information, finerenone is a mineralocorticoid receptor antagonist; its formulation is indicated for adult patients with chronic kidney disease associated with type 2 diabetes who also have albuminuria, to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage renal disease, cardiovascular death, and hospitalization for heart failure.
In recent years, the Group has positioned itself in both domestic and international markets, continuously advancing the high-end development of injectable formulations, the diversification of oral dosage forms, and the specialized development of active pharmaceutical ingredients. As a result, it has gradually established an integrated “API-plus-formulation” product chain spanning areas such as anti-infectives, antivirals, respiratory diseases, neurological disorders, nephrology, cardiovascular and cerebrovascular diseases, gastroenterology, anesthesia, and endocrinology. Leveraging process optimization and digital transformation, the Group has consistently strengthened its quality and cost advantages, becoming a reliable partner for numerous formulation manufacturers and providing sustained momentum for the efficient translation of corporate innovation into commercial success.
 

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