REGULATORY INFORMATION
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Regulatory Status |
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| United States | |
| FDA (Food and Drug Administration) | The FDA has not challenged a self affirmed status GRAS (Generally Recognized As Safe) status and approved products containing vitamin E TPGS. The FDA includes vitamin E TPGS in the list of inactive ingredients |
| USP (United States Pharmacopeia) | The USP published a monograph for vitamin E TPGS in the USP/NF Supplement #9 dated of November 15, 1998 |
| Canada | Approved as a form of vitamin E |
| European Community | Approved as an API (Active pharmaceutical Ingredient) The European Medicines Agency granted on July 24, 2009 marketing authorization for vitamin E TPGS (brand name Vedrop® of Orphan Europe S.A.R.L.) for the treatment of vitamin E deficiency due to digestive malabsorption in pediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis Meets IPEC-PQG GMP guidelines |
| EFSA | The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC Panel) of the European food safety authority (EFSA) on April 17, 2007 approved TPGS for use in foods for special medical purposes. |
| Japan | Approved as of September 2005 as a pharmaceutical excipient for oral drug formulations |
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