OMEGA-3 API'S

 

QUALITY ASSURANCE

The quality of purity
The Noera USA focuses on quality excellence and the continual improvement of technology. As part of this process we take into consideration global health, as well as our overall footprint on the environment. The Noera USA strives to produce Omega-3 fatty acid products that exceed the highest purity standards.

The Noera USA integrated Quality System uses the highest standards during manufacturing and the release of its products. Our high-quality Omega-3 fatty acid products comply to current Good Manufacturing Practices (cGMP). The Noera USA is fully committed to delivering innovative solutions that address a broad range of pharmaceutical, food and dietary supplement needs.

Noera USA's Active Pharmaceutical Ingredient
Dietary Supplement Master File (Hisun Bio Inc)

Noera USA's unique technology mix produces Omega-3 concentrates of the highest quality and purity, while producing a wide range of Omega-3 EPA and DHA fatty acids.

EPA fatty acids can be concentrated up to 99 % and DHA up to 95%. In addition, our technology allows for the production of specialty products like the NOERA CLINICAL STRENGTH OMEGA-3 FISH OIL. The production process for all products is completed under GMP conditions.

API’s are available in scalable quantities. All products can be produced as an ethyl ester, triglyceride or free fatty acid with the standard package size for all products being 190 kg drums that are flushed with inert gas. The tables below outline our standard product formulations. Additionally, Noera USA is capable of developing a variety of customized compositions according to your needs.

Noera USA's Approved Pharmaceutical Ingredients (APIs, mg/g)
CAPSULES & SPECIALTIES

Noera USA co-operates with leading GMP certified encapsulation companies. It is through these partnerships that we are able to supply finished gel caps using a variety of our purified oils. The capsules can be adjusted in form, size and gelatin to meet a specific need. The capsules are oval or oblong in shape and the gelatin shell can be produced from either bovine or fish.

NOERA CLINICAL STRENGTH OMEGA-3 FISH OIL is Noera USA's own gel cap product which contains over 90% Omega-3 fatty acid .

OMEGA-3 PHARMA GRADE BENEFITS

Omega-3 APIs are approved for the treatment of hypertriglyceridemia, arteriosclerosis obliterans, and coronary heart disease in various geographies around the world. In addition, Omega-3s are being researched as pharmaceuticals in numerous other conditions, including Noera USA's own product for familial adenomatous polyposis (FAP).

To meet the exacting demands of the pharmaceutical industry, Noera USA produces oil to its proprietary clinical strength standard. The purity of Omega-3 fish oil is not only measured in the concentration of the individual fatty acid, but in several categories that determine overall quality. The Noera USA measures purity using a combination of the following parameters:

  • Concentration of individual fatty acids, such as EPA, DHA, DPA
  • Concentrations of minor fatty acids down to levels less than 0.1%
  • Contaminate levels such as heavy metals, PCB's or pesticides
  • Product oxidation
  • Polymer content

In order for a Noera USA oil to be considered clinical strength it needs to achieve a high level of standard in each parameter. The best experience in separation technology has provided Noera USA with the knowledge necessary to ensure batch-to-batch consistency. The clinical strength standard is what has made Noera USA the largest manufacturer of Omega-3 APIs in the world.