Sucanon, which is a dietary supplement containing natural ingredients, is an oral type-II diabetes treatment.
PharmaRoth CEO Luis Lopez said that the filing of the application is a major milestone in the evolution of Sucanon.
"Though the product is classified as a drug in some countries, in the U.S. it will be marketed as a dietary supplement because of the nature of its ingredients," Lopez added.
"The NDI designation is important to show the safety of our dietary ingredient, which has always been a hallmark of Sucanon’s value."
NDI notification process, which aims at determining the safety of the main active ingredient(s), is required by the FDA as part of the process that products go through to gain access to the US markets.