Focusfreda successfully passed the injection-grade sodium hyaluronate active pharmaceutical ingredient qualification On-site Registration Inspection and GMP Compliance Check
Good news: Recently, Focusfreda successfully passed the on-site registration inspection for injectable-grade sodium hyaluronate active pharmaceutical ingredient (API) and the Good Manufacturing Practice (GMP) compliance inspection organized by the Shandong Provincial Center for Food and Drug Evaluation and Inspection. This marks Focusfreda's first domestic registration project for an injectable API, signifying a critical milestone in the company's registration efforts for injectable-grade sodium hyaluronate API.
The inspection team strictly adhered to the Good Manufacturing Practice (GMP), key requirements for drug registration inspections, and relevant regulatory standards. They conducted comprehensive, rigorous, and meticulous on-site inspections and document reviews at the active pharmaceutical ingredient (API) production lines and manufacturing facilities, focusing on the entire lifecycle management of sodium hyaluronate API—including its research and development, production, quality control, and storage release processes.
Following a four-day comprehensive and rigorous on-site inspection, the expert team unanimously recognized the company's robust quality management system, advanced production facilities, and professional technical team. They concluded that Focusfreda's research and production facilities largely corresponded to the submitted registration documents, with authentic and reliable data. The quality management system operates in compliance with GMP standards, enabling the company to produce injectable-grade sodium hyaluronate active pharmaceutical ingredients (APIs) on a large scale, in a standardized manner, and with sustained stability. Focusfreda successfully completed both the on-site registration verification and GMP compliance inspection for its injectable-grade sodium hyaluronate API.
The successful completion of these two inspections will lay a solid foundation for obtaining the "A" status registration number for the injectable-grade sodium hyaluronate active pharmaceutical ingredient, demonstrating that the company's comprehensive capabilities in drug R&D, production, and quality control have once again earned high recognition from national regulatory authorities.
In the future, Focusfreda will continue to uphold its core quality philosophy: "Guided by technological innovation to create value for customers; rooted in quality and safety to lead the future of health." The company will continuously refine its GMP quality management system, enhance its pharmaceutical production control and quality assurance capabilities, strictly adhere to compliance standards, and deepen its commitment to quality management, thereby building strong momentum for its high-quality development and strategic transformation in the pharmaceutical sector.
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