Wheat starch (containing gluten) used as an excipient

European Medicines Agency - EMA
European Medicines Agency
Publication date:
20 November 2018


Report outlining issues caused by use of wheat starch in medicines. The EMA will now require a specification of the content of gluten per tablet containing wheat starch and allow a statement of “gluten-free” when concentration is less than 20 ppm in the final medicinal product.