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    Supply Source

    Gnosis: Forging Ahead in Fermentation

    Gnosis, Desio, Italy, owns and operates two pharmaceutical cGMP-approved manufacturing facilities located in Southern Italy and Switzerland.

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    Rebecca Wright09.01.11
    Gnosis, Desio, Italy, owns and operates two pharmaceutical cGMP-approved manufacturing facilities located in Southern Italy and Switzerland. Established in 1989, it specializes in the manufacturing and sales of fermentation-derived raw materials and natural finished products applied to the pharmaceutical, nutraceutical, cosmetic, veterinary and agricultural industries.
     
    With the intention of self-representation in the U.S. market, it set up operations in Pennsylvania late last year. “Our focus is to introduce Gnosis products and services and create long-term direct contact relationships with existing and propspective partners,” said Mike Petteruti, vice president, Gnosis-USA.
     
    Gnosis’ key branded proprietary ingredients for the nutraceutical industry include: BiOOptima brand of probiotics, including S. boulardii and L. acidophilus; folate brands, including Quatrefolic, EXTRAfolate-S and EXTRAfolate; SAM-e branded and non-branded products, including pure powder, tablets and proprietary applications—SamEspresso and SupereSSe; and vitamin K2, including VITAMK7 (menaquinone7).
     
    According to Mr. Petteruti, Gnosis’ pharmaceutical-based processes combined with its technical and manufacturing capabilities have helped establish it as a leader in supplying proven nutritional ingredients and APIs (active pharmaceutical ingredients) to many of the most recognized global consumer products, pharmaceutical and nutritional companies around the world.
     
    “We recognize the increasing demand by the regulatory community, companies and consumers for substantiated, reliable, proprietary products manufactured to the highest (i.e., pharma grade) level of quality in the U.S. nutraceutical market,” he said. “This trend and demand is perfectly aligned with Gnosis’ philosophy and strategy, making our products and participation in the market a clear benefit and opportunity for our consumer product partners, consumers and certainly for Gnosis.”
     
    To this end, the company recently unveiled its latest innovation—Quatrefolic. Referred to as a 4th generation folate, it possesses the following advantages: accepted NDI filing by FDA; greater bioavailability (compared to 5-methylfolate calcium salt form); ability to penetrate cells without being metabolized; greater solubility (compared to 5-methylfolate calcium salt form) to facilitate improved formulating flexibility; greater stability to facilitate improved formulating flexibility; ability to formulate in combination with vitamins and minerals without patent infringement issues; GRAS (generally recognized as safe) status; proprietary and patented; trademarked; and cGMP manufactured.
     
    This offering has already earned the company an award. In fact, Quatrefolic received first prize out of three top finalists and from a group of 18 candidates during the Gala dinner held in Geneva on May 11th in connection with the Vitafoods Exhibition. The independent and impartial expert judging panel recognized Gnosis and its new compound Quatrefolic for excellence in: innovative patent design, high quality product development, flexibility and choice for the consumer, recognizing market and consumer demands and trends, strategic market orientation, project planning and execution and overcoming research and development challenges.
     
    Excited about the company’s prospects but cognizant of future challenges, Mr. Petteruti commented, “We are encouraged to see the industry continues to recognize the need to evolve to a standard that includes products that are not only of unquestionable quality, but also of proven consumer benefit and accountable performance. There is, in our opinion, still too much confusion and a lack of standardization, with regard to manufacturing, methodology and substantiation, which if not addressed for improvement by our industry could be detrimental through harsh regulatory imposition or consumer dissatisfaction.” 
     
    For the future, he said, Gnosis would continue to work with its partners to address human needs in improving health and nutrition. “In the near future you will see our product line continue to diversify to include APIs such as antibiotics, as well as other functional and proprietary nutritional ingredients and unique applications. We will also focus more on collaborative and partnering opportunities for the development and commercialization of products.” —R.W.
     
    Gnosis-USA Inc.
    169 No. Main St.
    Doylestown, PA 18901
    Telephone: 215-340-7960 x100
    Fax: 215-340-1351
    E-mail: mike.petteruti@gnosis-us.com
    Website: www.gnosis-bio.com
     
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