Tersus Nutraceuticals Ingredients
At Tersus Life Sciences, we take pride in offering scientifically validated, high-purity ingredients like Provinal®, backed by FDA notifications and global quality certifications. Below is a summary of key regulatory and manufacturing credentials.
| Provinal® TG | 50 KG | Provinal® triglyceride purified omega-7 (50% Palmitoleic acid) | PLA50-50TG | Oil |
| Provinal® EE | 50 KG | Provinal® ethyl ester purified omega-7 (50% Palmitoleic acid) | PLA50-50 | Oil |
| Provinal® EE | 180 KG | Provinal® ethyl ester purified omega-7 (50% Palmitoleic acid) | PLA50-180 | Oil |
| Provinal® TG | 180 KG | Provinal® triglyceride purified omega-7 (50% Palmitoleic acid) | PLA50TG | Oil |
| Provinal® EE Bulk Softgels | 100M - 10 oval‘ | Provinal® ethyl ester purified omega-7 (50% Palmitoleic acid) | PSG-10M | Softgel (Bovine) |
Certifications & Regulatory Status
GRAS: GRN No. 494
Fatty acid ethyl ester from anchovy or menhaden oil, standardized to approximately 50 percent palmitoleic acid
| Intended Use: | As an ingredient in foods |
| Basis: | Scientific Procedures |
| Notifier: | Tersus Pharmaceuticals, LLC |
| Date of Filing: | Dec 24, 2013 |
| GRAS Notice (releasable information): | GRN 494 (in PDF) (1.4 MB) |
| Date of Closure: | Dec 16, 2014 |
| FDA's Letter: | FDA has no questions |
FDA New Dietary Ingredient (NDI)
FDA New Dietary Ingredient Approval
NDI 1105, Omega-7 fish oil under the trade name Provinal® Tersus Life Sciences, LLC
Provinal® Manufacturing
KGMP, JGMP, and EU HACCP certified manufacturing facilities with complete quality control and assurance. Our product is compliant with quality requirement by global organizations such as EU Pharmacopeia, KFDA, PMDA, EU HAPPC, and US Pharmacopeia.
Proven manufacturing partners since 2011 providing the highest quality products with technology producing D/S and API.