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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group’s Guolong Pharmaceutical Receives Approval for Bumetanide API
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发布时间：2026-03-16
【概要描述】
On March 16, the bumetanide API developed by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, successfully changed its registration status to “A” at the Center for Drug Evaluation of the National Medical Products Administration, thereby qualifying as an API used in marketed dosage forms. Since the beginning of this year, the Group has received approval for a total of six new specialty APIs.
On March 16, the bumetanide API developed by Hebei Guolong Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, successfully changed its registration status to “A” at the Center for Drug Evaluation of the National Medical Products Administration, thereby qualifying as an API used in marketed dosage forms. Since the beginning of this year, the Group has received approval for a total of six new specialty APIs.
According to available information, bumetanide is a loop diuretic indicated for the treatment of edematous conditions (such as congestive heart failure, liver cirrhosis, and renal disease), hypertension, prevention of acute renal failure, hyperkalemia and hypercalcemia, and syndrome of inappropriate antidiuretic hormone secretion (SIADH), among others.
The Group continues to deepen its integrated “API + formulation” development model. To date, it has 97 API products, including 43 under China Dragon Pharmaceutical, with product lines spanning multiple therapeutic areas such as cardiovascular, anti-infective, and central nervous system. The proportion of specialty APIs has been steadily increasing, providing strong momentum for the company’s innovative, high-quality growth.
The approval of bumetanide API will further accelerate the development and strategic positioning of bumetanide dosage-form products, thereby achieving effective synergy between the formulation and the API and enhancing market accessibility.
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