BINZHOU, China – March 2026 –

Shandong Binzhou Zhiyuan Biotechnology Co., Ltd., a dedicated specialist in the field of functional excipients, is proud to announce a significant breakthrough in its corporate development. The company has successfully obtained the Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for its Betadex Sulfobutyl Ether Sodium product. This prestigious certification marks a new chapter for the company, affirming its technical expertise and opening doors to international markets.

Since its inception, Binzhou Zhiyuan Biotechnology has recognized the immense potential of cyclodextrin. As a functional excipient characterized by its unique cyclic molecular structure, cyclodextrin plays a vital role across numerous sectors, including pharmaceuticals, food, daily chemicals, and agriculture, owing to its exceptional solubilizing, encapsulating, and stabilizing properties. Committing itself to this niche market, the company has evolved from small-batch trial productions to operating a state-of-the-art production facility equipped with advanced machinery and a comprehensive quality control system. This journey of growth has been fueled by the ingenuity of its R&D team and the dedication of its production staff.

For sixteen years, the company has maintained a meticulous focus on process research and development. Significant human, material, and financial resources have been consistently invested in process optimization and technological innovation. The R&D team has conducted in-depth studies on the molecular structure and reaction mechanisms of cyclodextrin to continuously refine production parameters. Every step of the process—from raw material selection and fermentation preparation to separation, purification, and final product testing—has been repeatedly optimized. Through a strategy combining independent research with technology introduction, Binzhou Zhiyuan has successfully overcome numerous technical challenges. These efforts have resulted in significantly improved product purity and yield, reduced production costs, and a minimized environmental footprint.

Betadex Sulfobutyl Ether Sodium (SBECD) is a novel solubilizer and stabilizer widely used in injectable formulations of poorly soluble drugs, including critical medications such as remdesivir, voriconazole, and aripiprazole. The acquisition of the CEP certificate for this key product is not only an authoritative endorsement of Binzhou Zhiyuan’s R&D capabilities and stringent production quality systems but also establishes a new trajectory for the company’s leapfrog development in the global pharmaceutical excipient market. This achievement positions Shandong Binzhou Zhiyuan Biotechnology Co., Ltd. for continued growth and innovation as it strives to provide high-quality solutions to its customers worldwide.