Omega-3 API and drug substances
KD Pharma is the largest producer of omega-3 based APIs. Its unique technology mix produces Omega-3 drug substances of the highest quality and purity. We offer concentrates with EPA up to 99% purity, DHA up to 95% purity, and can custom manufacture concentrates of almost any other fatty acid.EPA fatty acids can be concentrated up to 99 % and DHA up to 95%.
KD Pharma can provided commercial and development-scale companies fully customized APIs as ethyl ester, triglyceride, free fatty acids or other forms.
The tables below outline our existing DMF products. Additionally, KD Pharma is capable of developing a variety of customized compositions according to your needs. All products are made in GMP facilities.
KD Pharma's Approved Pharmaceutical Ingredients (APIs, mg/g)
KD-Pür® (mg/g) Pharmaceuticals
PRODUCT | EPA | DHA | EPA + DHA | OMEGA-3 FATTY ACIDS |
Omega-3 Acid Ethyl Esters | ||||
460380EE (EP) | 430-495 | 347-403 | 800-882 | NLT 90% |
465375EE (USP) | 430-495 | 347-403 | 800-880 | NLT 90% |
46037EE (JP) | 430-495 | 347-403 | 800-880 | NLT 90% |
Icosapent Ethyl | ||||
EPA965EE (EP & USP) | 965-980 | not defined | not defined | not defined |
EPA96% (JP) | 96.5%-100.0% | not defined | not defined | not defined |
EP - European Pharmacopeia, USP - US Pharmacopeia, JP - Japanese Pharmacopeia