The Australian Authorities announced that Larch arabinogalactan is now approved as a therapeutically active ingredient for oral use.
Three requirements have to be met for approval all of which are fulfilled by Lonza's active ingredient: the ingredient arabinogalactan (Larix) is derived from Larix larcinia or Larix occidentalis; the concentration of polysaccharides in the ingredient arabinogalactan (Larix) is greater than or equal to 85 per cent; and the maximum recommended daily dose of the ingredient arabinogalactan (Larix) is not to exceed 15 grams.
In Australia, Larch arabinogalactan had been approved before as a food additive only, a Lonza press release said.
"This new approval is good news, as Larch arabinogalactan, which we sell as an ingredient for use in products positioned for digestive health benefits under the brand name, FiberAid, was not approved for such applications in Australia", comments René Blum, Global Head of Regulatory Affairs for the Nutritional Ingredients at Lonza.
FiberAid is self-affirmed GRAS (Generally Recognized As Safe) with FDA notification. In the European Union, Arabinogalactan is listed in the Novel Food catalogue published on June 17th, 2008 for use as a food supplement.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically.