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    Breaking News

    Health Canada Authorizes Health Claims for AP-Bio/KalmCold

    The standardized Andrographis panniculata extract can be marketed for upper respiratory tract infection relief.

    Health Canada Authorizes Health Claims for AP-Bio/KalmCold
    03.29.22
    AP-Bio, an Andrographis panniculata extract marketed by Natural Remedies Private, recently received authorization through a product license from Health Canada (NPN license #80117041). The Natural and Non-prescription Health Products Directorate (NNHPD) concluded that the application is in compliance pursuant to section seven of the Natural Health Products Regulations (NHPR).
     
    As part of the approval, Health Canada authorized that brands may claim that 200 mg of AP-Bio (marketed as KalmCold in Europe) “helps to reduce symptoms of common cold and upper respiratory tract infections (such as sore throat, cough, runny nose, fatigue, plugged nose, and fever). Helps to reduce/relieve the severity of symptoms associated with upper respiratory tract infections (e.g., common cold and flu)."
     
    The claim is based on three human clinical studies supporting the role that the ingredient has in managing symptoms related to upper respiratory challenges, and for positively modulating immunity.
     
    AP-Bio is standardized to contain 35% andrographolide, a compound from the leaf of Andrographis panniculata, in addition to six other plant constituents. “This full profile of actives makes AP-Bio a potent Andrographis for a variety of immune support formulas,” Deepak Mundkinajeddu, PhD, Natural Remedies’ head of R&D, said.
     
    “Canadian consumers can feel good not only about the science behind AP-Bio’s immune support properties, but that it is ethically and sustainably cultivated, harvested, and processed,” Abey Thomas, head of marketing for Natural Remedies, said. Thomas noted that the ingredient is Non-GMO Project certified, USP-compliant, is part of a sustainable supply chain, and is certified Halal and Kosher.

    In addition, Thomas noted that Natural Remedies recently completed a 90-day toxicity study on AP-Bio. “Our brand partners and their consumers can now trust that AP-Bio can be used long-term without any safety concerns,” he said.
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