Bloomage Passes GMP Audit by South Korea's MFDS, Strengthening its Global Quality Assurance
PARSIPPANY, NJ., March 18, 2025 /PRNewswire/ -- Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has successfully passed the GMP on-site inspection by South Korea's Ministry of Food and Drug Safety (MFDS) with no observations of non-compliance. This certification reinforces Bloomage's commitment to quality assurance of pharmaceutical-grade products, ensuring compliance with South Korea's stringent regulatory standards and enhancing its ability to supply high-quality bioactive ingredients for the South Korean market.
MFDS conducted the three-day audit in November, 2024, rigorously assessing six major systems including quality management, material management, production management, equipment and facilities, packaging & labeling, and laboratory control.
MFDS is a formal member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international body that harmonizes GMP standards across global regulatory agencies, including the US FDA, Japan PMDA, and major EU regulatory authorities.
By meeting MFDS's strict pharmaceutical standards, Bloomage is now positioned to provide GMP-certified pharmaceutical-grade Sodium Hyaluronate (Hyatrue®) to Korean pharmaceutical manufacturers of ophthalmology, orthopedics, aesthetic medicines, and regenerative medicines, covering Eyedrops, intra-articular injections, dermal fillers, mesotherapy solutions tissue engineered products, and so on.
To date, Bloomage's Sodium hyaluronate has successfully passed four US FDA audits, one Japan PMDA audit, and nearly ten China NMPA audits, demonstrating the company's industry-leading quality management and comprehensive capabilities.
"Quality, safety, and compliance are that forefront of everything we do at Bloomage," noted Chunzi Song, General Manager of Bloomage's South Korean subsidiary. "Successfully passing the MFDS audit with zero deficiency is a testament to Bloomage's unwavering commitment to high-quality, pharmaceutical-grade bioactive solutions and reinforcing our confidence to further strengthen local partnerships. This zero-deficiency result from the MFDS audit shows our ability to support South Korea's rising demand for high-quality health products, and our dedication to developing scientifically validated ingredients that meet stringent global regulatory standards."
Building on this momentum, Bloomage will continue expanding its presence in South Korea, driving innovation and setting new benchmarks in bioactive materials. As an innovation-driven enterprise, we maintain an unwavering commitment to quality and scientific excellence, providing cutting-edge solutions for global partners across pharmaceuticals, medical aesthetics, regenerative medicine, and emerging therapeutic areas. Upholding this mission, Bloomage will continue delivering value to its more than 4,000 customers across 70+ countries, shaping the future of global bioactive innovation.
About Bloomage
Since its founding in 2000, Bloomage has grown into a leading international company specializing in the research, development, production, and sale of hyaluronic acid and other bioactive substances for the pharmaceutical, cosmetic and functional foods industries. Bloomage's commitment to quality, innovation, and sustainable innovations have established the company as a trusted name for some of the world's most renowned brands. It now serves more than 4,000 customers in over 70 countries.
Learn more at Bloomagebioactive.com
CONTACT:
Cecilia Qian
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SOURCE Bloomage
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