How Gummies Are Made: A Contract Manufacturer's Guide

Commercial gummy production runs on a starch mogul or a depositing line. Starch moguls cast syrup into starch trays, which is slower but handles high-pectin and high-dose formulas. Depositing lines use a servo-driven nozzle head to fill moulds at 2.0 g to 5.0 g per gummy, then move trays into a curing tunnel. A single line can output 1.2 million gummies per day. EUPHM runs both configurations, which matters when your formula needs a specific texture or a larger active load.

Moulds are either metal or starch-based. Metal moulds give sharper edges and faster demoulding, but they limit shape complexity. Starch moulds allow deeper cavities and better control for sugar-free or low-moisture recipes. Changeover between SKUs takes 4–6 hours, including cleaning and first-article checks. For orders above 500,000 units, dedicated tooling is cost-effective. For smaller runs, shared tooling keeps MOQ at 1,000 units per SKU.

The gelling agent decides texture, melting point and vegetarian status. Gelatin gives a springy chew and melts at 35°C, which is why it dominates mainstream vitamins. Pectin sets with calcium ions and holds up better in warm climates, but it needs a higher solids content and precise pH control between 3.2 and 3.8. Starch-based gummies suit sugar-free recipes using maltitol or allulose. Each system changes the cooking temperature: gelatin batches cook to 80–85°C, pectin batches to 105–108°C.

Active ingredients are added after cooking, during the holding stage, to protect heat-sensitive vitamins. Vitamin C, B-complex and zinc slurries are dosed by weight at 25–40°C. Oil-based actives such as omega-3 or vitamin D3 need emulsification to avoid separation. Overages of 5–15% are common to meet label claim at end of shelf life. Flavour and colour are added last, then the batch is held under vacuum for 20–30 minutes to remove air bubbles before depositing.

After depositing, gummies cure for 24–72 hours in a temperature-controlled room at 20–25°C and 30–40% relative humidity. Curing removes surface moisture and sets the final chew. In-process checks include Brix, pH, weight per gummy and texture. A batch fails if weight deviates by more than ±5% or if the texture is outside the approved range. Finished gummies are coated with oil or wax to stop sticking, then packed into bottles or sachets.

Compliance starts with the facility. A GMP-certified, ISO 22000 and HACCP site documents every batch, from raw material COAs to finished product micro tests. Third-party lab testing covers potency, heavy metals and microbial limits. For halal or vegan claims, the relevant certification must be in place before production, not after. EUPHM holds these certifications and can supply documentation for your regulatory filing in the US, EU, UK or Middle East.

Every commercial gummy batch is tested against a written specification before release. Identity and potency testing confirms that actives such as vitamin C, D3 or melatonin fall within 90–110% of label claim at the time of manufacture. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella, with typical limits of under 1,000 cfu/g for total aerobes. Heavy metals are screened by ICP-MS for lead, arsenic, cadmium and mercury, and disintegration testing follows the USP <2040> method to confirm the gummy breaks down within the required time.

Testing is staged rather than carried out only at the end. Incoming raw materials are quarantined until identity is confirmed by FTIR or HPLC. In-process checks monitor depositing weight, Brix and pH at intervals of 30 to 60 minutes. Finished-product testing happens after curing, typically 48 to 72 hours post-depositing, because potency and texture stabilise only once the gel matrix has set. A batch is not released until the quality team signs the certificate of analysis against the approved specification.

The certificate of analysis (COA) issued with each lot should list the product name, lot number, manufacture and expiry dates, the tests performed, the specification limits, the results and the method used. It should be signed by an authorised quality representative. Buyers sourcing gummy production in China should request a COA for the actual production lot, not a generic template, and confirm that the lot number matches the cartons and bottles shipped.

Retention samples are held for the shelf life plus 12 months, typically two full retail units per lot, stored under labelled conditions. Stability follows a protocol of accelerated testing at 40°C and 75% relative humidity for six months, plus real-time testing at 25°C and 60% relative humidity for the declared shelf life. Vitamin potency, colour, texture and microbial status are checked at 0, 3, 6, 12, 18 and 24 months, which supports the expiry date printed on the label.

Gummies are packed in HDPE bottles with induction seals, in blister packs, in stick packs or in single-serve sachets. Bottle sizes commonly run from 60 to 180 counts, with 60 and 90 count the most requested for retail. Blisters suit pharmacy channels and travel formats, while stick packs and sachets suit sample programmes and subscription boxes. Desiccant is added where humidity control matters, and bottles are induction-sealed and shrink-banded for tamper evidence.

For the US market, the label must carry a Supplement Facts panel with serving size, active quantities and % Daily Value where established, plus the ingredient list, allergen statement, net quantity, directions and the manufacturer or distributor address. Lot number and expiry date are printed by inkjet or laser on the bottle and the carton, and must match the COA. For the EU, the nutrition declaration and health-claim wording follow Regulation 1169/2011 and the applicable claims register.

Carton specifications are agreed before production. A typical shipper holds 12 to 24 retail bottles, with gross weight and carton dimensions stated on the packing list. Pallets are built to 1,200 by 1,000 mm or 1,200 by 800 mm depending on destination, with stretch wrap and corner boards. Amazon sellers should confirm FNSKU labelling, poly-bagging where required and carton weight limits before the run, because rework after production adds cost and delay.

Retail readiness also covers artwork approval and barcode verification. GS1 barcodes are checked for print quality, and a pre-production proof is signed off before plates or digital files are finalised. Buyers should confirm who owns the artwork files, how label revisions are version-controlled and what happens if a label error is found after packing. A written packaging specification, signed by both parties, prevents most disputes at the point of shipment.

Sample development typically takes 7 to 10 working days from receipt of the brief and signed formulation. The sample stage covers flavour, texture, colour and active loading, and most projects need one or two rounds of adjustment. Once the sample is approved in writing, mass production runs 20 to 35 working days depending on line scheduling, packaging complexity and whether labels and cartons are supplied by the buyer or produced locally.

Shipping method depends on volume and urgency. Air freight moves 100 to 500 kg in 5 to 10 days door to door and suits launch quantities; sea freight is economical above roughly 500 kg and takes 25 to 40 days to Europe or North America, plus customs clearance. Gummies are temperature-sensitive, so summer shipments may need insulated packaging or a temperature-controlled container, which should be quoted separately.

Incoterms are agreed in the quotation. EXW places collection at the factory, FOB places cost and risk at the named Chinese port, and DDP places delivered duty paid at the buyer's address. DDP is convenient for smaller buyers but carries higher unit cost and less visibility of the import charges. Buyers should confirm who is the importer of record and who bears duty, VAT and customs clearance.

The document pack issued with each shipment includes the commercial invoice, packing list, bill of lading or airway bill, COA, MSDS where applicable, and a free-sale certificate. For plant-derived ingredients, a phytosanitary certificate or certificate of origin may be requested. Buyers should check the documents against the purchase order before the container leaves, because corrections after departure are slow and can hold up clearance at destination.