CoQ10 Softgel Manufacturer for Global Supplement Brands

EUPHM operates rotary die softgel encapsulation lines with a daily capacity of up to 1.2 million softgels. For CoQ10, we use a fill system that keeps the active in a stable oil suspension. The gelatin or vegan shell is formed, filled and sealed in one continuous process. This limits oxidation and ensures consistent fill weight across the batch.

The plant handles both small pilot runs and full retail production. MOQ for retail bottling is 1,000 units per SKU. For brands testing a new CoQ10 dosage, we can run smaller pilot batches. Every batch is traceable from raw material lot to finished bottle. Standard lead time for mass production is 20–35 working days after sample approval.

CoQ10 is available as ubiquinone or ubiquinol. Ubiquinol is the reduced form and is more sensitive to oxidation, so we formulate it with careful antioxidant protection. Common carriers include MCT oil, olive oil and flaxseed oil. We can also add vitamin E or rosemary extract to help maintain stability over shelf life.

Fill weights range from 50 mg to 200 mg per softgel. The softgel shell can be gelatin-based or vegan (starch or carrageenan). For halal certification, we source gelatin from certified suppliers. Organic and options are possible when the CoQ10 and carrier oils meet organic standards. We provide formulation support to match your label claims.

The facility is GMP-certified and operates under ISO 22000 and HACCP food safety systems. Incoming CoQ10 raw material is tested for identity, potency and heavy metals. During production, we monitor fill weight, shell thickness and seal integrity. Finished softgels are tested for CoQ10 content, microbial limits and oxidation markers.

Documentation includes certificates of analysis, safety data sheets and allergen statements. We support halal certification through accredited bodies. For US and EU buyers, we provide the technical file needed for regulatory review. EUPHM does not claim FDA approval; the facility is FDA-registered where relevant for US imports.

Every CoQ10 softgel batch is tested at three stages: incoming raw material, in-process fill weight and finished product. Raw CoQ10 is assayed for identity and potency by HPLC, with a specification of 98.0–101.0% of label claim. Microbial limits follow USP <2021> and <2022>, heavy metals are tested by ICP-MS against USP <232> limits, and disintegration is checked to USP <2040> within 30 minutes. Each test is recorded against a unique batch number and retained for five years.

A certificate of analysis (COA) is issued for every batch and includes the batch number, manufacture and expiry dates, fill weight, appearance, identification, assay result, microbial results, heavy metals, disintegration time and a statement of GMP compliance. Retention samples of at least twice the finished batch quantity are stored at 25°C/60% RH for the shelf life plus six months. Stability is monitored at 0, 3, 6, 12, 18 and 24 months for potency, peroxide value and disintegration.

In-process controls run every 30 minutes during encapsulation: fill weight is checked against a ±5% tolerance, seam thickness is measured, and softgels are inspected for leaks and shape defects. Any deviation triggers a hold and a documented investigation. Environmental monitoring of the softgel room covers air particulate and surface swabs monthly. Water activity and moisture content of the gelatine shell are also recorded to prevent brittleness or tackiness during storage.

CoQ10 softgels can be packed in HDPE bottles from 30 cc to 500 cc, blisters of 10 to 30 softgels, stick packs or single-serve sachets. Standard bottle fills are 60, 90, 120 or 180 softgels. We apply induction seals, desiccant sachets where needed and child-resistant closures on request. Blister material is PVC/PVDC or alu-alu for moisture-sensitive formulas. Cartons are printed to your artwork with lot number and expiry date inkjet-coded on both bottle and carton.

For the US market, labels must carry the supplement facts panel, serving size, amount per serving, other ingredients, allergen statements, and the manufacturer/distributor address. We can format the supplement facts panel from your formula and check it against 21 CFR 101.36. For the EU, we apply the nutrition declaration, recommended daily dose, and the mandatory “food supplement” statement. Lot and expiry coding follow your chosen format (DD/MM/YYYY or YYYY/MM) and are verified against the batch record before release.

Cartons are specified with board grade, print colours and dimensions to fit your bottle count. Standard export cartons hold 12, 24 or 48 bottles, with a maximum gross weight of 15 kg for manual handling. Pallets are 1200 x 1000 mm or 1200 x 800 mm, stretch-wrapped and corner-boarded, with 48 to 60 cartons per pallet depending on bottle size. For Amazon FBA, we apply FNSKU labels, poly-bag the units where required and prepare cartons to the FBA carton weight and labelling rules.

Sampling starts with a formulation brief and target dose. We provide a quotation within two working days and a sample in 7–10 working days for standard formulas. Custom colours, flavours or carrier oils add 3–5 working days. Sample costs are credited against the first production order. Mass production runs 20–35 working days after sample approval, depending on softgel size, packaging format and whether the artwork is print-ready. Peak season (August to November) may add 5–7 working days.

We ship under EXW, FOB Shenzhen or Hong Kong, and DDP for door-to-door delivery. Air freight takes 5–8 days to the US or EU, while sea freight takes 28–35 days to the US West Coast and 30–38 days to Northern Europe. For small orders under 500 kg, air or express is usually more cost-effective. We provide a packing list, commercial invoice, and bill of lading or airway bill for each shipment. Shipping documents are issued within three working days of dispatch.

Each order includes a COA, material safety data sheet (MSDS) for the finished product, and a free-sale certificate where required. For plant-based softgels, we can supply a vegan statement. A phytosanitary certificate is not normally required for softgels, but we can arrange it if your import country requests it. Certificates of origin can be issued for preferential tariff treatment. We also provide artwork proofs and dieline files for your packaging designer before printing.