Explore our CE-compliant, cGMP-manufactured bulk and OEM Omega-3 softgel solutions. Formulated with molecularly distilled marine & vegan oils engineered for optimal bioavailability.
As a global authority in turn-key nutraceutical contracting, our certified state-of-the-art manufacturing facility bridges the gap between raw marine lipid extraction and high-velocity commercial production. Sourcing premium-grade omega-3 requires rigorous control over oxidation parameters, lipid chemical structures (EE vs. TG/rTG), and molecular distillation purity. We operate strict FDA 21 CFR Part 111 cGMP-compliant production suites optimized for heat- and oxygen-sensitive essential fatty acids.
Utilizing low-temperature vacuum distillation cascades to remove environmental contaminants, heavy metals (Lead, Mercury, Cadmium, Arsenic), dioxins, and PCBs down to undetectable parts-per-billion (ppb) levels.
Every single batch undergoes rigorous evaluation in our on-site analytical laboratory. We verify identity, active EPA/DHA potencies via Gas Chromatography (GC), peroxide values (PV), and anisidine values (AV) prior to lot release.
Our production protocols conform with European Standardized requirements, EU Regulation (EC) No 1881/2006 for maximum contaminant levels, and international regulatory frameworks for seamless market clearance.
Oxidation is the single greatest threat to oil stability. Our high-speed Rotary Die encapsulation lines process softgels under positive continuous nitrogen blankets, keeping Total Oxidation (TOTOX) consistently below industry standards.
From custom bottle selection (HDPE, PET, Amber Glass) and blister thermoforming to automated cartooning and outer sleeve shrink wrapping, we supply consumer-ready products built for immediate retail listing.
We craft tailored ratios ranging from balanced 18/12 EPA/DHA to specialized high-EPA (500mg/g+) for cardiac health or high-DHA (400mg/g+) for prenatal and cognitive formulations.
Our raw material sourcing and finished softgel formulations adhere to strict chemical, heavy metal, and microbiological parameters verified by Certificate of Analysis (COA) per production lot.
| Analytical Parameter | Commercial Grade Specification | Pharma / CE Grade Specification | Testing Methodology |
|---|---|---|---|
| Acid Value | ≤ 1.0 mg KOH/g | ≤ 0.5 mg KOH/g | USP <401> / Ph. Eur. 2.5.1 |
| Peroxide Value (PV) | ≤ 5.0 meq/kg | ≤ 2.5 meq/kg | AOCS Cd 8b-90 / PV Titration |
| Anisidine Value (AV) | ≤ 20.0 | ≤ 15.0 | AOCS Cd 18-90 / Spectrophotometry |
| Calculated TOTOX (2PV + AV) | ≤ 26.0 | ≤ 10.0 (Ultra-Fresh Standard) | Calculated Index |
| Heavy Metals (Pb, Hg, Cd, As) | < 0.1 ppm Combined | < 0.01 ppm Undetectable | ICP-MS (USP <233>) |
| PCBs & Dioxins | Conforms to EU 1881/2006 | Below WHO Detection Limits | HRGC / HRMS |
| Disintegration Time | < 30 Minutes | < 15 Minutes (or Enteric Controlled) | USP <2040> Softgels |
The global Omega-3 dietary supplement landscape is undergoing a structural evolution. Sourcing directors, brand owners, and retail distributors must align their procurement strategies with emerging regulatory shifts, scientific breakthroughs, and raw material dynamics. When acquiring bulk softgels or initiating custom OEM projects, forward-thinking buyers prioritize three decisive industry shifts:
While Ethyl Ester (EE) forms historically dominated low-cost manufacturing, global demand is shifting aggressively toward Re-esterified Triglycerides (rTG). Scientific clinical trials confirm that the rTG structure exhibits up to 70% higher biological absorption compared to standard EE oils. Modern consumers are increasingly demanding premium bioavailability, making rTG concentrations the highest-growing SKU category across Europe and North America.
Environmental vulnerability in traditional pelagic fish harvests (anchovy, sardine, and mackerel fisheries in Peru and Chile) has accelerated the growth of fermentation-derived algal oils. Schizochytrium sp. algae provides a direct source of active EPA and DHA without marine ecosystem impact. Procurement channels are securing dual-track supply chains—offering both marine-sourced fish oil and clean-label, plant-based vegan Omega-3 softgels.
Pill fatigue is driving consumer preference away from traditional 1000mg softgels containing low (30%) active omega-3 content toward 80%+ ultra-concentrated formulations. By utilizing advanced multi-stage molecular fractionation, contract manufacturers can now deliver 800mg to 900mg of pure EPA/DHA inside a single, easy-to-swallow 1000mg capsule, dramatically reducing consumer dosing friction.
Differentiating an Omega-3 brand in a crowded market requires continuous technical innovation. As a turnkey contract factory, our R&D department collaborates with brand partners to engineer novel formulations that deliver measurable health outcomes and superior sensory attributes.
Eructation (commonly referred to as "fishy burps") remains the leading cause of consumer trial abandonment. Traditional softgels dissolve rapidly in the acidic environment of the stomach, releasing volatile lipid compounds. Our advanced enteric coating technology applies a natural, food-grade polymer layer to the softgel shell. This ensures the capsule remains fully intact through the gastric acid of the stomach and disintegrates specifically in the higher pH environment of the upper small intestine, guaranteeing zero odor and maximum user compliance.
Omega-3 fatty acids serve as an ideal lipophilic carrier matrix for fat-soluble bioactives. We specialize in compounding high-stability multi-ingredient formulas that unlock elevated retail price points:
Our facilities operate under strictly audited global quality standards to back your brand's regulatory filings.
Everything procurement officers and brand directors need to know regarding contract manufacturing terms, certifications, and quality controls.
CE Certification in nutraceutical manufacturing indicates full adherence to European safety, health, and environmental protection standards. It confirms that the manufacturing facility operates under validated Good Manufacturing Practices (GMP) capable of fulfilling stringent EU regulations (such as Regulation EC No 178/2002 and EC No 1881/2006 for contaminant thresholds). This allows finished products to move seamlessly through European customs clearance and market distribution.
Our standard MOQ for custom-formulated or custom-printed softgels begins at 300,000 capsules per production run. For stock bulk formulas with standard gelatin shells, we accommodate smaller batch sizes starting at 100,000 softgels (or roughly 1,500 to 3,000 finished retail bottles, depending on count per bottle). Contact our sales engineering team for flexible pilot scale options.
We mitigate oxidation risks through a 4-tier preservation protocol: 1) Sourcing crude oils processed under nitrogen; 2) Continuous nitrogen flushing across all holding tanks, blending vessels, and encapsulation hoppers; 3) Fortification with natural mixed tocopherols (Vitamin E) or rosemary extract antioxidants; and 4) Utilizing light-barrier primary packaging (such as amber PET bottles or opaque Alu-Alu blisters).
Yes. Every shipment includes a comprehensive documentation package comprising the Certificate of Analysis (COA), Certificate of Free Sale (CFS), Batch Production Records, Allergen Statements, Non-GMO Declarations, BSE/TSE-free certification for gelatin components, and Stability Testing Reports per ICH guidelines upon request.
Standard turnaround time for repeat orders of established formulations takes approximately 3 to 4 weeks. For new custom formulations requiring custom raw material procurement, specialized tooling, or unique outer packaging creation, lead times generally range between 5 and 7 weeks. Accelerated scheduling is available upon request.
Absolutely. In addition to traditional pharmaceutical-grade bovine, porcine, and fish gelatins, we operate specialized softgel encapsulation lines utilizing Tapioca and modified Seaweed starch (Carrageenan-free options available). Combined with our pure microalgae-derived EPA/DHA oils, we offer fully certified 100% plant-based vegan Omega-3 products.
Talk directly with our senior formulation chemists and procurement account executives. Receive technical pricing, custom MOQs, and sample batch evaluations.