Focusfreda's injectable-grade sodium hyaluronate has been granted the CDE "I" status registration, marking its expansion into high-end pharmaceutical applications.
Focusfreda has recently secured the "I" status registration (Registration No.: Y20250001123) for its independently developed injectable-grade sodium hyaluronate API from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. This milestone follows the company's earlier achievement of "A" status registration for its eye-drop-grade sodium hyaluronate API, demonstrating Focusfreda's substantial progress in high-end pharmaceutical API R&D and industrialization. The breakthrough highlights the company's sustained innovation capabilities and technical prowess in the industry.
The submitted injectable-grade sodium hyaluronate API is primarily used in the production of sodium hyaluronate injections for treating joint diseases such as osteoarthritis. The product features high purity and low impurities, meeting the stringent requirements for manufacturing sodium hyaluronate injections.
Focusfreda has been building a comprehensive compliance system covering R&D, production, and quality management. From establishing GMP-compliant pharmaceutical-grade production lines to obtaining the CDE "A" status registration (Registration No.: Y20230000698) for eye drop-grade active pharmaceutical ingredients, and successfully filing medical device master documents (M2025008-000, M2025052-000), the company has developed a systematic quality assurance capability for high-end pharmaceutical APIs. The recent acquisition of the "I" status registration for injectable-grade active pharmaceutical ingredients not only expands the company's product portfolio but also highlights Focusfreda's comprehensive strengths in R&D innovation and production quality management.
Going forward, Focusfreda will remain committed to advancing high-quality development in active pharmaceutical ingredients (APIs), accelerating the transition of injectable-grade APIs to Grade A status. By strengthening its production quality management system and delivering superior, cost-effective products and services, the company aims to become a trusted strategic partner for pharmaceutical enterprises, steadily advancing in the high-end pharmaceutical sector.
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