Jan. 17, 2026
Recently, Shandong Runhan Biotechnology has achieved a significant milestone—its core product, N-Acetyl Glucosamine (NAG), has successfully obtained U.S. Self-GRAS (Generally Recognized As Safe self-affirmation) certification. This accomplishment signifies that Runhan's NAG product has gained authoritative international recognition for its safety and compliance, adding a crucial asset to the company's global strategy in green bio-manufacturing.
The GRAS standard (Generally Recognized As Safe) is an internationally recognized core food safety standard led by the U.S. FDA. Self-GRAS certification, based on scientific evidence including toxicology data, production process evaluations, and historical usage records, confirms the safety of the product under its intended conditions of use. Its rigor and scientific credibility are widely trusted in global markets. Passing this certification demonstrates that Runhan's NAG product meets high international safety standards, paving the way for its entry into the North American market and broader global markets.
Shandong Runhan Biotechnology Co., Ltd., founded in 2021, specializes in the field of synthetic biology and bio-fermentation. It is a comprehensive biotechnology company integrating R&D, production, marketing, international trade, and technical services across the entire value chain. The company's main products include bio-fermented products such as N-Acetyl Glucosamine (NAG), which are widely used in dietary supplements, functional foods, skincare products, infant foods, dairy products, and more. The annual production capacity for NAG has reached 3,000 tons, demonstrating its capability for large-scale supply. The NAG product that has now achieved certification is a clear reflection of the company's core competitive strength.
N-Acetyl Glucosamine (NAG), as an essential component of glycosaminoglycans, is known for its effects in improving joint lubrication, slowing joint degeneration, alleviating joint inflammation, and reducing joint pain. Consequently, it is widely used in areas such as bone and joint health and skincare. With the rise of global health consciousness, the NAG market is expanding at a steady growth rate. North America, as a core consumer market, exhibits significant demand potential.
For Shandong Runhan Biotechnology, obtaining the Self-GRAS certification is not only a strong testament to product safety but also demonstrates the company's comprehensive capabilities in green bio-manufacturing. Through rigorous scientific assessment and continuous optimization of production processes, Runhan ensures its NAG product is of high purity and quality, meeting international market expectations for both safety and efficacy.
Looking ahead, Shandong Runhan Biotechnology stated that it will continue to optimize its product portfolio, enhance its global compliance framework, and empower partners worldwide with high-quality ingredients. The company plans to further expand the application of NAG and other bio-fermented products in sectors such as sports nutrition, cosmetics and skincare, and pharmaceutical health, driving innovation and upgrading within related industries. Runhan remains committed to its green synthetic biology technology pathway, contributing scientific and technological power to human health and better quality of life through sustainable production methods.
Against a backdrop of increasingly intense global competition in bio-manufacturing, Shandong Runhan Biotechnology has secured a key passport to the international market, leveraging its deep technological expertise, forward-looking compliance strategy, and the advantage of a 3,000-ton annual production capacity. The successful achievement of Self-GRAS certification stands as a significant milestone in this young biotech firm's globalization journey and provides a compelling example for China's bio-manufacturing enterprises on how to win global trust through innovation and quality.
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