On October 25, 2023, the Therapeutic Goods Administration of Australia (TGA) unveiled an announcement on its official website: Infinitus' proprietary patented ingredient, Folium Cyclocarya Paliurus Extract*, has been approved for inclusion in the list of therapeutic goods. This approval allows for the research and development, and the sale** of complementary medicines in the Australia and New Zealand regions.
Complementary medicines encompass naturally derived products with established traditional applications, demonstrated benefits for human health, and a robust safety profile. In Australia, "complementary medicines" share a common composition with "dietary supplements" in the United States and "health foods" in China. However, their unique legal classification as "medicines" and their stringent regulatory requirements set a global standard. To meet the TGA's stringent criteria for complementary medicinal ingredients, the quality standards for Folium Cyclocarya Paliurus Extract adhere to the United States Pharmacopeia (USP) guidelines. Comprehensive toxicological safety assessments have been conducted in the globally recognized Good Laboratory Practices (GLP) laboratory***. Furthermore, internationally esteemed clinical trials demonstrate**** that a 12-week regimen of Folium Cyclocarya Paliurus Extract effectively curbs post-meal blood glucose spikes, notably reducing glycated hemoglobin (HbA1c) levels in participants.
Given TGA’s rigorous requirements, a mere 38% of applications for the base components of complementary medicines received approval in 2021. Until this juncture, there have been no approvals for Chinese herbal-based complementary medicines.
Folium Cyclocarya Paliurus Extract has once again secured recognition, this time from the esteemed TGA in Australia. This accomplishment follows its initial approval as a "New Dietary Ingredient" by the U.S. Food and Drug Administration (FDA) in December 2021. By gaining approval from two of the world's most rigorous regulatory bodies, our proprietary core ingredient for promoting healthy blood sugar levels underscores its exceptional safety, effectiveness, and quality control. This milestone stands as a pivotal example of Infinitus' global expansion and the internationalization of Chinese herbal medicine.
Central to the formulation of S-Harmony Herbal Vege Capsules is the Folium Cyclocarya Paliurus Extract, synergistically combined with Dendrobium Nobile, Astragalus, Dioscorea Opposita, and Salvia Miltiorrhiza. This comprehensive approach focuses on three pivotal aspects: inhibition, balance, and protection, and may support maintaining a healthy blood glucose level. The S-Harmony Herbal Vege Capsules have been bestowed with a plethora of certifications, including the prestigious Q-Mark Quality Product Certification in Hong Kong, SGS Safety Certification, formula patents in the United States and and Taiwan*****. This product, sourced from pure plants, bears no artificial colors, flavors, preservatives, hormones, or sugar additives, making it a suitable choice for vegetarians and vegans. It is currently registered for overseas distribution in Hong Kong, Kazakhstan, and Canada and is available on Infinitus' e-stores in China, Taiwan, South Korea, Australia, and New Zealand, where it has garnered resoundingly positive reviews from consumers.
As we progress, Infinitus will remain committed to producing high-quality Chinese herbal products, while advocating the premium Chinese health regimen, co-creating healthier and happier lives for all.
*Folium Cyclocarya Paliurus extract Chinese national patent number: ZL 2017 1 1048084.6
** More information is available for download at the official TGA’s website (https://www.tga.gov.au/resources/resource/compositional-guidelines)
***This GLP laboratory holds OECD recognition, making its reports globally accepted by 34 OECD member countries and 7 Mutual Acceptance of Data (MAD) countries, setting a "universal standard."
****The clinical trial is officially registered with the United States National Institutes of Health (NIH), bearing project number NCT04184440.
*****S-Harmony Herbal Vege Capsules U.S. patent number: US10960044B2, Taiwan (China) patent number: invention patent No. I709416)
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