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Konan And REJIMUS Secure No Objection Letter From FDA For Rhamnox 100

By PR Newswire

PR Newswire
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Yokkaichi-City, Japan – Konan Chemical Manufacturing Co., Ltd., a leading Japanese innovator of novel industrial, food and dietary supplement ingredients and REJIMUS, INC., a preeminent regulatory management consultancy to the Food/Beverage and Dietary Supplement markets for GRAS and NDI Notifications in the United States, proudly announce the receipt of a FDA "No Objection Letter" for the Rhamnox 100 New Dietary Ingredient (NDI).

YOKKAICHI-CITY, Japan, Aug. 2, 2023 /PRNewswire-PRWeb/ -- Konan Chemical Manufacturing Co., Ltd., a leading Japanese innovator of novel industrial, food and dietary supplement ingredients and REJIMUS, INC., a preeminent regulatory management consultancy to the Food/Beverage and Dietary Supplement markets for GRAS and NDI Notifications in the United States, proudly announce the receipt of a FDA "No Objection Letter" for the Rhamnox 100 New Dietary Ingredient (NDI).

"The Konan family is pleased to have achieved this great milestone by adding Rhamnox 100 to its Rhamnox portfolio of novel ingredients derived from Monostroma nitidum Wittrock that have been successfully FDA notified, furthering our commitment to growth in the US marketplace as well as around the world," said Mr. Joji Otani, President of Konan Chemical Manufacturing Co., Ltd. "We have seen an incredible demand for new food ingredients requiring demonstration of safety and compliance that have persevered the FDA notification process, and we are proud to have met such demands with this continued success for our current and future customers."

Rhamnox 100 is a novel water extract from Monostroma nitidum Wittrock, a green algae native to the Japan region, grown in open ocean seaweed farms along the coasts of the Mie Prefecture in central and western Japan. The originating material has a consumption history dating back for several hundreds of years, and while various extracts have been consumed commercially dating back to early 20th century, Rhamnox 100 has demonstrated in the recent years to be very versatile in a variety of food applications in Japan as well as the Greater Asia and Australasia regions. For the US market, the conditions of use are that the New Dietary Ingredient Rhamnox 100 be consumed with liquid and have a maximum serving size of 200mg/day for a duration of up to six weeks.

"REJIMUS, INC. was pleased to have earned the opportunity and enabled Konan to achieve another major success within the US marketplace with this NDI Notification (NDIN) for Rhamnox 100," said Brandon Griffin, CEO of REJIMUS, INC. "We have a phenomenal team of specialists and proven track record of successful first-time NDI Notifications enabling clients to get their ingredients into the marketplace faster. We know our role, we know the risks, we know the investment needed to get to that critical point of generating revenue or establishing proof of concept for our clients better than most."

About Konan Chemical Manufacturing Co., Ltd.:

Konan Chemical Manufacturing Co., Ltd. is a leading Japanese industrial, food and dietary ingredient development company specializing in Monostroma nitidum Wittrock novel extracts. To learn more about Konan's Rhamnox 100 and other current development initiatives, ingredients, and other services for US customers, please visit: https://www.konanchemical.com/en/products/foods.htm

About REJIMUS, INC.:

REJIMUS, INC. is a preeminent FDA and cGMP regulatory management consulting firm enabling companies in the Food & Beverage, Dietary Supplement, Cosmetic and Homeopathic/OTC markets get novel ingredients and finished products into the US marketplace faster, while ensuring efficient compliance with the applicable regulations for their operations and supply chain. For more information on the markets served and service offerings, please visit: https://www.rejimus.com

Pull Quote

Konan Chemical Manufacturing Co., Ltd. and REJIMUS, INC. proudly announce the receipt of a FDA "No Objection Letter" for Rhamnox 100 New Dietary Ingredient.

Media Contact

Dianne Strickland, REJIMUS, INC., 1 9494852112, info@rejimus.com, https://www.rejimus.com

SOURCE REJIMUS, INC.

First published on Wed, Aug 2, 2023

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REJIMUS Konan Chemical Manufacturing Regulatory Management Consulting New Dietary Ingredient (NDI)

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