Lutein Gummy Manufacturer for Eye Health Supplements

The gelling system decides texture, melting point and vegetarian positioning. Pectin gummies are plant-based, hold up in warm climates and suit vegan and halal claims, but they need tighter control of pH and soluble solids. Gelatin gives a springier chew and faster setting, and works well with oil-based lutein suspensions. Hybrid systems blend starch, pectin and gelatin to hit a target bite.

We run all three. Typical pectin gummies sit at 2.5–3.5 g per piece; gelatin formats run 2.0–3.0 g. Water activity is held below 0.65 to limit microbial growth, and we adjust humectants for the destination market. If your brand sells into the Gulf, we can target a higher melting point so gummies survive 40°C transit and retail shelves.

Lutein is sensitive to light, heat and oxygen. We dose free lutein or lutein esters from 5 mg to 20 mg per gummy, with a declared overage — commonly 10–30% — to hold label claim at end of shelf life. The overage is set by accelerated stability data, not by habit. We can also blend zeaxanthin at a 5:1 or 4:1 lutein-to-zeaxanthin ratio if your label calls for it.

Carotenoids colour the gummy, so we match a target shade with natural sources rather than fighting the active. Flavour systems are built to mask the slightly earthy note of lutein esters: citrus, berry, mango and peach are common. Oil-based suspensions need an emulsifier and a controlled deposition temperature, otherwise you get streaking or uneven dosage across the batch.

Every batch is tested for assay, uniformity, water activity, texture and microbiology before release. We retain samples for the full shelf life and keep batch records traceable to raw material lot. Certificates of analysis, allergen statements, nutrition panels and halal certificates are issued with each shipment. We are an FDA-registered facility and hold GMP, ISO 22000 and HACCP certifications.

For logistics, we ship FOB Shenzhen or Yantian, with air freight for pilot runs and sea freight for full containers. Retail-ready bottling runs from 30 to 120 count, with induction seals, child-resistant caps and cartons. We can label in English, Arabic or bilingual formats, and we work with your freight forwarder or ours. Lead time from PO to port is typically 20–35 working days.

Every lutein gummy batch is tested against a written specification before release. Identity of the lutein source is confirmed by HPLC against a reference standard, and potency is assayed as free lutein or lutein esters depending on the input. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella. Heavy metals are screened for lead, arsenic, cadmium and mercury against the limits in USP <2232> or the relevant market regulation. Disintegration is run on the finished gummy to confirm it breaks down within the pharmacopoeial window for the chosen base.

In-process checks run during production, not only at the end. Gel mass is checked for pH and Brix before depositing, and lutein is added at a verified temperature to limit isomerisation and colour drift. Deposited gummies are weighed at intervals to confirm fill weight, and the overage is calculated from the assay of the incoming raw material so the label claim is met at end of shelf life. Colours are measured against a retained standard under controlled lighting to catch batch-to-batch variation.

The certificate of analysis (COA) issued with each batch lists the product name, batch number, manufacturing date, expiry date, and the result and specification for each test. It names the analytical methods used and is signed by the QC manager. A retention sample of at least twice the quantity needed for full testing is held for the shelf life plus six months. Stability is monitored on the commercial pack at 25°C/60% RH and 30°C/65% RH, with accelerated conditions at 40°C/75% RH for three and six months to support the claimed expiry.

Documentation is released as a batch pack: COA, master batch record extract, packing record, and where required a statement of allergen status and a GMO statement. If your market requires a free-sale certificate or a phytosanitary certificate, these are applied for at the time of shipment. All records are retained for at least five years so a retail audit or a notified body inspection can be answered from the file.

Lutein gummies are packed in HDPE bottles with induction seals and child-resistant closures, in blister packs, or in stick packs and sachets for single-serve formats. Bottle sizes are typically 60, 90 or 120 count, with desiccant where the base and the carotenoid require it. Stick packs suit a 30-day or 15-day course and reduce exposure to air. We can quote on stock tooling or on custom bottle and closure moulds, and we confirm the pack format before the stability study so the data matches the pack you sell.

For the US market the label follows FDA dietary-supplement rules: statement of identity, net quantity, supplement facts panel with lutein in mg per serving, other ingredients in descending order, and the name and place of business of the distributor. Structure/function claims are permitted only with the required disclaimer and must be supportable. For the EU and UK the label follows food supplement rules with the % NRV where a reference intake exists and the permitted vitamin and mineral forms. We do not write claims for you, but we check that the artwork carries the mandatory elements before printing.

Lot and expiry coding is applied at packing, with the format agreed in advance (for example LOT and EXP with day/month/year). Cartons are specified with gross weight, dimensions and count per carton, and pallets are built to a stated height and pattern for container loading. For Amazon and other marketplaces we apply FNSKU labels and poly-bag the units where required, and we can print and apply retail-ready cartons with the correct barcodes. We do not guarantee marketplace compliance; the seller remains responsible for the listing and claims.

Artwork is proofed against a checklist before plates are made: mandatory label elements, barcode scan check, and a final PDF approval signed by the buyer. Printing is quoted per pack format, and we hold a retained printed sample from each run. If you sell into the Middle East, we can add Arabic labelling and confirm the halal status of the base and the lutein source. Shipping marks and carton labelling are agreed with the freight forwarder before production ends.

Sampling starts from an approved formula. We send a quotation and a draft specification, then produce a sample in 7 to 10 working days once the formula and pack are agreed. Sample cost is quoted per project and is typically credited against the first mass-production order. If you need a new flavour, colour or base, add about 5 working days for a bench trial. We do not start a sample without a signed specification so the trial matches what you intend to sell.

Mass production runs 20 to 35 working days after purchase order and deposit, depending on pack format and whether printed packaging is new. Bottle filling is usually at the shorter end; stick packs and blisters at the longer end. MOQ is 1,000 units per SKU. If you order several SKUs, we can schedule them in one production window to reduce changeover cost, but each SKU carries its own MOQ.

Air freight is used for samples and urgent launches, typically 5 to 10 days door to door. Sea freight is used for full containers and takes about 25 to 40 days depending on destination port. We quote EXW, FOB and DDP; DDP is available for the US, EU, UK and selected Middle East markets where we have a cleared forwarder. Incoterms and the named place are written into the proforma invoice so there is no ambiguity at shipment.

The shipping document set includes commercial invoice, packing list, bill of lading or airway bill, COA for each batch, MSDS where the carrier requires it, and a free-sale certificate on request. A phytosanitary certificate is not normally relevant to a gummy, but we will supply it if your import authority asks. Certificates of origin can be issued for preferential tariff treatment where the rules of origin are met. All documents are checked against the order before the container is released.