In continuing to provide industry-leading silicone materials around the globe, NuSil began to produce Simethicone USP products for the pharmaceutical industry in 2004. Since then, NuSil has been manufacturing Simethicone USP (100%) and Simethicone GS (30% Granular Solid).
As cited in FDA regulations 21 CFR332.10 and 21 CFR332.15 these products are considered safe and effective over-the-counter drugs to alleviate the symptoms of gas associated with heartburn, sour stomach, acid indigestion and post operative gas pain. Simethicone products may also be used in microbial fermentations or pharmaceutical processing where foam-control is needed.
Each product is manufactured under strictly controlled conditions using cGMP guidelines for Active Pharmaceutical Ingredients (APIs) and excipients in our U.S. FDA registered manufacturing site in Bakersfield, California. Kosher and Halal certifications for the manufacturing processes of the Simethicone product line are available upon request.
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