A Billion Daily Doses Since Its Introduction
Metafolin® is our manufactured calcium salt of L-5-methyltetrahydrofolic or L-methylfolate. As an alternative to folic acid, it offers good stability, solubility and bioavailability. A testament to its quality, a billion daily Metafolin® doses have been taken to protect and improve health since its introduction in 2001.
Metafolin® L-methylfolate has an extensive record of success with regulatory authorities and fulfills the specifications of the United States Pharmacopoeia (USP) and in some cases exceeds these specifications.
- 1999 USA: GRAS (generally recognized as safe) self-affirmation for Metafolin® L-methylfolate
- 2001 U.S. FDA: New Dietary Ingredient Notification for Metafolin® L-methylfolate
- 2004 EFSA (EU) considers Metafolin® L-methylfolate as safe
- 2005 JECFA considers Metafolin® L-methylfolate as safe
- 2006 EU Commission published 2006/34/EC and 2006/37/EC with Metafolin® L-methylfolate
- 2007 Metafolin® L-methylfolate approved in Switzerland and Norway
- 2009 Approved in Canada for use in dietary supplements
- 2015 TGA approval for Metafolin® L-methylfolate in Australia
- Available and can be used as an active pharmaceutical ingredient (API). Metafolin® L-methylfolate is protected by a comprehensive set of patents and patent applications on the substance, key intermediates, production processes and its use in specific fields. As a result of this protection, Metafolin® can be licensed to selected companies in clearly-defined market segments. Metafolin® is a registered trademark of Merck KGaA, Darsmtadt, Germany.
Metafolin® is also known as L-methylfolate; L-5-MTHF-Ca; L-methylfolate calcium; L-5-Methyltetrahydrofolic acid, calcium salt; [6S]-5-Methyltetrahydrofolic acid, calcium salt.
For more information regarding Metafolin® L-methylfolate, please contact us.