Buchang Pharma secures drug approval, expands production capabilities

Shandong Buchang Pharmaceuticals Co., Ltd. has received a supplementary drug application approval for Xiaolin Baidu San from the National Medical Products Administration. This approval transfers the marketing authorization holder of Xiaolin Baidu San to Shandong Buchang Pharmaceuticals Co., Ltd., effective November 15, 2025. The traditional Chinese medicine, used for clearing heat and detoxifying, represents a significant investment, with approximately CNY 28,150,000 in R&D expenses for its powder and pill forms.

Concurrently, the company also obtained an updated Drug Production License, increasing its production scope. This includes the addition of a comprehensive preparation VI workshop (pill production line) at its facility in Heze City, expanding its production capabilities to include pills.

Furthermore, the updated license extends the validity of entrusted production for several drugs, including desloratadine tablets, montelukast sodium chewable tablets, ibuprofen sustained-release capsules, and ezetimibe tablets until July 16, 2028; pregabalin capsules until March 31, 2028; and donepezil hydrochloride tablets until July 7, 2030. These changes are expected to optimize the company's production structure and maintain stable production capacity.