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Gnosis is pleased to announce that its manufacturing facility based in Sant’Antonino, Switzerland, has received US Food and Drug Administration (FDA) approval.
The inspection, the first in the Swiss facility, was closed earlier than planned without issuing any 483 observation. FDA approval confirms the high quality standard of Gnosis ingredients and quality systems, and consolidates the company’s leading position as a biotechnology company specialised in the manufacturing of fermentation raw materials and natural finished products used in the pharmaceutical and nutraceutical industries.
The manufacturing facility operates in the production of active nutraceutical and pharmaceutical ingredients and is designed to meet environmental, health and safety challenges using water-based purification technology.
The site is located in the industrial area of Sant’Antonino in the canton of Ticino, approximately 10km south of Bellinzona, and became part of Gnosis’ group as Gnosis Bioresearch S.A. in 2004 when acquired from Abbott.
It has also been inspected by ANVISA, Swissmedic and holds several certifications including Kosher.
The facility is dedicated to yeast based products, SAMe, Saccharomyces boulardii and Glutatione, for both pharmaceutical and dietary supplement applications.
S-Adenosylmethionine (SAM-e) is one of the most active methyl donors produced in the human body and is involved in more than 100 biochemical pathways. Gnosis has developed several formulations and products covered by granted patents and patent pending applications: SAMESPRESSO™, SAMEDRINK™ and SUPERESSE™.
Saccharomyces boulardii is a strain of non-pathogenic, non-colonising yeast with probiotic properties used both for the prevention and the alleviation of diarrhea and other gastrointestinal disorders. Gnosis produces S. boulardii with the brand of BIOOPTIMA™ as pharmaceutical and dietary supplement ingredient.
L-Glutathione has been the subject of intense research during the last 30 years and has been studied and described in nearly a 1,000 scientific papers for its antioxidant action. Gnosis has also recently developed a new form that enters the cells directly and once inside the cell is converted to GSH. The product is sold with the brand of SAGACE™.
With over 20 years of experience in microbial fermentation and an international manufacturing network dedicated to high-quality and proprietary products, Gnosis is specialised in manufacturing and sales of fermentation raw materials and natural finished products used in the pharmaceutical, nutraceutical and veterinary industries.
The Gnosis Group includes a European manufacturing network made up of three operating divisions and three commercial operations located in Italy, the US and China.
Successful integration between the R&D centre and GMP-approved manufacturing facilities enables the company to constantly work to develop and introduce groundbreaking and market-leading products to the worldwide market.