877-870-0159 info@tpgs.com

TPGS Regulatory Status


USP/NF  A National Formulary (NF) monograph is in the United States Pharmacopeia / National Formulary (USP/NF) version USP 40 – NF 35.
DMF Status Antares Vitamin E TPGS, NF Grade has an Active Type IV Drug Master File, #28188 
GRAS Status Vitamin E TPGS has a self-affirmed GRAS (Generally Recognized As Safe) status when used as an oral dietary supplement of vitamin E
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.
Clean Label Tocopherol Polyethylene Glycol Succinate (TPGS) is considered equivalent to Vitamin E and can be labeled as such.
Canada Approved as a form of vitamin E
European Community Meets IPEC-PQG GMP guidelines. Approved as an API (Active Pharmaceutical Ingredient). On July 24, 2009, the European Medicines Agency granted 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 choleostasis or hereditary chronic choleostasis.
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 (FSMP).
Japan Approved as of September 2005 as a pharmaceutical excipient for oral drug formulations