Omega-3 Softgel Manufacturer for Private Label Brands

Our softgel line runs 500 mg, 1,000 mg and 1,200 mg fill weights as standard, with custom sizes from 300 mg to 1,500 mg. We produce oval, oblong and round shapes, and can apply enteric coating for delayed release. The line handles both triglyceride (TG) and ethyl ester (EE) omega-3 oils, plus algal DHA and flaxseed oil.

Bottling runs from 60 cc to 250 cc HDPE or PET, with induction seals, child-resistant caps and desiccant options. Typical line capacity supports 1,000 units per SKU for retail bottling, and lower volumes for pilot runs. Bulk softgel delivery in polybags is also available if you bottle in-house.

We work with three main omega-3 sources: fish oil (anchovy, sardine, mackerel), algal oil (DHA-rich, vegan), and plant oils such as flaxseed. Concentration options include 18/12 standard, 33/22 mid-range and 50/20 or higher concentrates. Each batch is tested for EPA/DHA content, peroxide value, anisidine value and heavy metals.

Formulation support covers natural or synthetic vitamin E as an antioxidant, lemon or orange masking for fishy aftertaste, and softgel shell options using bovine, porcine or fish gelatin, or vegetarian starch. If you need a specific ratio, we can match it. Flavour masking and enteric coating are common for 1,000 mg and 1,200 mg doses.

EUPHM is a GMP-certified facility with ISO 22000 and HACCP certification. Depending on the formula and your market, we can produce under halal certification. We are an FDA-registered facility, which supports US import requirements. Every batch ships with a certificate of analysis covering identity, potency, microbials and oxidation markers.

Shipping is typically by air or sea from Shenzhen or Hong Kong. Air freight for 1,000 units takes 5–8 days to the US or EU; sea freight takes 18–28 days. We handle documentation for customs, including commercial invoice, packing list, certificate of origin and health certificate where required. Lead time from deposit to dispatch is 20–35 working days.

Every omega-3 softgel batch is tested at three points: incoming oil, in-process fill, and finished goods. Incoming fish oil is checked for identity (fatty acid profile by GC), peroxide value, anisidine value, and PCB content. In-process checks cover fill weight uniformity (target ±5%), seam integrity, and shell thickness. Finished softgels are tested for EPA/DHA potency (typically 90–110% of label claim), microbial limits (TPC <1000 cfu/g, absence of E. coli and Salmonella), heavy metals (lead <0.1 ppm, arsenic <0.1 ppm, mercury <0.1 ppm, cadmium <0.1 ppm), and disintegration time (≤30 minutes for standard, ≤60 minutes for enteric-coated).

A certificate of analysis (COA) is issued per batch and includes: product name and softgel specification, batch number, manufacturing date, expiry date, test parameters with specifications and results, and a statement of conformity. Where a customer requires it, we include the oil supplier's COA and a statement on fish species and origin. Retention samples of each batch are held for 24 months from the date of manufacture under controlled conditions (25°C/60% RH) to support any post-market queries.

Stability testing follows ICH Q1A(R2) guidelines. Accelerated studies run for six months at 40°C/75% RH, with real-time studies at 25°C/60% RH for 24 months. Parameters monitored include potency, peroxide value, microbial counts, and disintegration. Results are documented in a stability report available to buyers under confidentiality. This data supports shelf-life claims of 24 months for standard softgels and 18 months for enteric-coated formats, subject to packaging configuration.

Omega-3 softgels can be packed in HDPE bottles (30, 60, 90, 120, 180, 240 count), blister packs (10 or 12 per card), stick packs (single-dose sachets), or three-side-seal sachets. Bottles are induction-sealed and fitted with child-resistant or standard caps. Blisters use PVC/PVDC or alu-alu for moisture protection. We can supply bottles with desiccant sachets or cotton, and cartons with or without tamper-evident seals. Typical bottle dimensions and fill weights are confirmed at sample stage.

For US market entry, labels must include: statement of identity, net quantity of contents, ingredient list, allergen declaration (fish), and a supplement facts panel with EPA and DHA amounts per serving. We can print FDA-compliant labels or work with your artwork. Lot number and expiry date are inkjet-printed on the bottle and outer carton. For EU and UK, labels require nutrition declaration, fish allergen in bold, and a best-before date. We also handle Amazon FNSKU labels and poly-bagged units for FBA shipments.

Cartons are specified as 5-ply corrugated with a maximum weight of 15 kg per carton. Pallets are standard 1200 x 1000 mm or 1200 x 800 mm, stretch-wrapped and strapped. We provide a packing list and pallet manifest for each shipment. For retail-ready packaging, we can apply hang tabs, shelf-ready trays, and display-ready cartons. All packaging materials are food-grade and meet EU 10/2011 and FDA 21 CFR 174-190 requirements.

Sample orders are typically 3-5 bottles per SKU, produced within 7-10 working days after formula and packaging confirmation. Samples are free for standard formulations; buyer covers courier costs. For custom ratios or enteric coating, sample lead time extends to 12-15 working days. Sample batches are produced on the same line as mass production, so they reflect actual fill weight, shell colour, and print quality.

Mass production lead time is 20-35 working days after receipt of deposit and approval of artwork and samples. This covers oil sourcing, softgel encapsulation, drying (typically 3-5 days), testing, and packaging. Peak season (Q3-Q4) may add 5-7 working days. We provide weekly production updates and a pre-shipment sample for approval before final packing.

We offer EXW, FOB Shenzhen or Hong Kong, and DDP for US and EU addresses. Air freight takes 5-8 days door-to-door; sea freight takes 25-35 days to US West Coast, 30-40 days to EU ports. Shipping documents include commercial invoice, packing list, bill of lading or airway bill, COA, MSDS, and a free-sale certificate. For shipments to the Middle East, we can arrange halal certification and legalisation of documents where required. Phytosanitary certificates are not applicable for softgels but can be provided for gelatine-free (vegetarian) options if needed.