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Pharmactive Affron receives stress relief claim approval from Ministry of Food and Drug Safety
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Wednesday, 25 February, 2026, 16 : 00 PM [IST]
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Madrid, Spain
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Pharmactive Biotech Products has announced that its flagship Affron saffron extract has received individual license approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for a stress relief claim. The approval follows a complex, two-year regulatory process conducted in collaboration with Hyundai Bioland Co., Ltd.
With this endorsement, Affron becomes the first saffron ingredient to be granted a stress relief claim by the MFDS and is currently the only ingredient to hold this recognition. Supplements containing Affron in South Korea will be eligible to carry the Health Functional Food (HFF) seal, a certification widely trusted by consumers across South Korea and the broader Asia-Pacific region.
According to the company, the MFDS is regarded as one of the most stringent regulatory authorities globally, requiring extensive documentation on quality, safety and efficacy. Pharmactive submitted a comprehensive dossier including chemical fingerprinting data, toxicological assessments, and evidence from pre-clinical and clinical studies. Advanced analytical tools such as High-Performance Liquid Chromatography (HPLC) were used to ensure batch-to-batch consistency and validate standardized concentrations of its active compounds, Lepticrosalides.
Affron is supported by 12 human clinical trials involving more than 1,000 participants. At least four of these studies specifically demonstrated benefits for occasional stress and mood. Preclinical research, including studies conducted in Korea, indicated that the extract may help regulate the hypothalamic–pituitary–adrenal (HPA) axis, a central component of the body’s stress-response system.
The approval strengthens Pharmactive’s position in South Korea’s rapidly expanding nutraceutical market, currently valued at approximately USD 14.8 billion and projected to grow significantly through 2033. The company’s partnership with Hyundai Bioland is expected to further accelerate regional expansion across South Korea and Southeast Asia.
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