Product Information

Pharmacopeia Information

F-MELT® is manufactured under strict quality control at our FDA-cGMP certified facilities. All components of F-MELTR Type C meet USP-NF, JP, EP. An US DMF Type IV filed for Type C in 2007.
F-MELT® Type M conforms to USP-NF and JPC.
All components of F-MELT® Type 1 is of food grade.

Safety

F-MELT® Type C and M:
The components of F-MELT® Type C , Type M are safe with no reports of adverse reactions when used as excipient in pharmaceutical applications. Type C is also suitable for nutraceutical/dietary supplement* applications. The components of Type C have E-numbers (EU Food Directive), and are listed in USA CFR 21, and list of Acceptable Non-Medical Ingredients in Canada. The maximum dosage of Grade M and C is 5.875 gram per day.
* Please check regulatory status of each component in respective countries.

F-MELT® F1:
Type F1 is for nutraceutical/food applications and all components are of food grade.

TSE/BSE, Non-GMO, Allergen Free Certificates are available upon request.

Stability

F-MELT® Type M and C have a shelf life of three years from the date of manufacture.
F-MELT® F1 has a shelf life of one year from the date of manufacture.
Real time stability studies which will lead to extension of shelf life are underway for Type F1.