Following more than two years of dedicated technical research and comprehensive regulatory preparation, our company has officially secured the CEP for Ursodeoxycholic Acid, marking a crucial milestone in our global pharmaceutical layout.

This full-process registration project was independently completed by our internal registration team. We built complete research dossiers and registration systems from scratch, and finished the entire EDQM review procedure without any external support, demonstrating our independent and mature overseas regulatory capability.

Facing diverse technical difficulties, our team conducted proactive risk assessment and completed dossier optimization. With seamless cross-departmental collaboration among R&D, Production, QA and QC teams, we established full impurity profiling and consolidated process validation data, responded professionally to regulatory inquiries, and broke through all technical bottlenecks steadily.

This outstanding achievement relies on the company’s forward-looking global strategy and strong resource support, as well as the joint efforts of all functional departments. Full internal collaboration underpins our steady expansion into high-end international pharmaceutical markets.

To date, we have obtained six CEP certificates in total, covering Diosmin (2 certificates), Anastrozole, Troxerutin, Irinotecan Hydrochloride and Ursodeoxycholic Acid. The growing CEP portfolio fully proves our product quality and production system fully comply with European Pharmacopoeia requirements.

Moving forward, we will take this approval as a new starting point. We will continue to strengthen our overseas registration competence, cope with escalating global regulatory requirements, and further expand our European market presence. We remain committed to delivering high-quality, compliant APIs to global partners and empowering the company’s long-term international development.