Focusfreda Successfully Passes On-site Inspection for Drug Production License Expansion
Recently, the Shandong Center for Evaluation and Inspection conducted a two-day on-site inspection for the sodium hyaluronate drug production license expansion at Focusfreda. The inspection primarily covered the injectable-grade active pharmaceutical ingredient (API) production line at the Lingcheng High-Tech Industrial Development Zone in Qufu, Jining City, Shandong Province. The aim was to comprehensively evaluate the production capacity and quality management system of the proposed production line for regulatory compliance and licensing.
In preparation for the inspection, Focusfreda established a dedicated task force months in advance to meticulously coordinate all preparations. Expert inspectors conducted a thorough, in-depth, and detailed review of Focusfreda’s API production facilities and workshops in accordance with the Good Manufacturing Practice (GMP) and relevant regulations.
Following rigorous on-site and documentation reviews, the expert panel concluded that the new production line meets all requirements for the production license, granting a successful pass. This marks a milestone as the first drug production license approval for Focusfreda’s Lingcheng facility. Passing the inspection is a critical milestone for domestic and international registration of injectable-grade APIs, signifying that the Lingcheng facility fully complies with GMP standards and possesses the capability for large-scale, standardized production. This provides a solid foundation for expanding into global markets.
Moving forward, Focusfreda will leverage this achievement to further enhance its GMP quality management system, strengthen pharmaceutical production and quality control capabilities, and drive substantial progress in corporate transformation toward high-quality development and strategic pharmaceutical advancement.
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