Melatonin Gummy Manufacturer for Global Supplement Brands

Our Guangdong plant runs two gummy lines with a combined output of 1.2 million units per day. Melatonin is dosed by inline volumetric pumps and verified by HPLC at three points: premix, deposition, and finished lot. Each batch is logged with a unique code for traceability. We can produce 1 mg to 10 mg per gummy, with dose variance held to ±5% for most formulas.

We handle bottle fills from 30 to 120 count, using HDPE or PET containers with induction seals. Packaging options include child-resistant caps, desiccant sachets, and label placement to your artwork. For pilot runs under 1,000 units, we run a shared line slot with a 10-15 working day lead time. Full-scale orders ship 20-35 working days after you approve the sample.

Melatonin works in a gummy when the active is protected from heat and moisture. We use a low-temperature deposition process at 65-70°C and a 48-hour curing room at 20-22°C and 35% RH. That keeps degradation under 3% over a 24-month shelf life. Common bases are pectin for vegan labels and gelatin for a chewier texture. Sugar-free versions use maltitol or allulose with stevia.

Flavour systems are matched to your market: mixed berry, cherry, orange, and mint are the most requested. We can add L-theanine, chamomile, or magnesium as co-actives. Colour comes from fruit and vegetable concentrates or natural pigments. For halal claims, we source gelatin and pectin from certified suppliers and keep separate production slots.

Every melatonin lot is tested for potency, microbials, heavy metals, and disintegration. We release a Certificate of Analysis with each shipment. The facility is GMP, ISO 22000, and HACCP certified. We are FDA-registered for US imports. For EU and UK orders, we provide documentation for novel food and supplement regulations. Halal certificates are available on request.

Shipping runs from Shenzhen and Hong Kong ports. Typical transit is 25-35 days to US West Coast, 30-40 days to EU and UK, and 15-25 days to Middle East ports. We ship FOB, CIF, or DDP. Air freight is available for urgent orders at 5-10 days. MOQ for repeat orders stays at 1,000 units, and we hold your formula and artwork for 24 months.

Every production batch of melatonin gummies is sampled at three stages: incoming raw material, in-process gummy mass, and finished packaged goods. Incoming melatonin is tested for identity by HPLC and for potency against the supplier certificate. Pectin or gelatin is checked for gel strength and microbial load. During production, the gummy mass is sampled every 30 minutes to confirm dose uniformity within ±5% of label claim. Finished gummies are tested for potency, microbials (total plate count, yeast and mould, E. coli, Salmonella), heavy metals (lead, cadmium, arsenic, mercury), and disintegration time. All testing follows methods aligned with USP <2023> for melatonin and <701> for disintegration.

A Certificate of Analysis (COA) is issued for each batch and includes the batch number, manufacturing date, expiry date, label claim, measured potency, microbial results, heavy metal results, disintegration time, and a statement of conformity. Retention samples of every batch are kept for the full shelf life plus six months, stored under controlled temperature and humidity. Stability testing follows a protocol of 0, 3, 6, 12, 18, and 24 months at 25°C/60% RH and 30°C/65% RH for accelerated conditions. Real-time data is available for review before shipment, and we can provide a stability summary for your regulatory dossier.

Microbial testing is performed on every batch, not just periodic checks, because gummies have a water activity that can support mould if drying is incomplete. Heavy metal testing uses ICP-MS and results are reported in ppm against the limits set by EU Regulation 2023/915 and US FDA guidance. Disintegration testing ensures gummies break down within 30 minutes for gelatin and 45 minutes for pectin, which matters for label claims and consumer experience. If a batch fails any specification, it is quarantined and not released. We do not offer 'pass by exception' on potency or microbials.

Melatonin gummies can be packed in HDPE bottles (60, 90, 120, or 180 count), blister packs, stick packs, or single-serve sachets. Bottles are induction-sealed and fitted with child-resistant caps where required by market. For US dietary supplements, the label must include the statement of identity, net quantity of contents, supplement facts panel with melatonin amount per serving, other ingredients, and the FDA disclaimer for structure/function claims. We can print lot numbers and expiry dates by inkjet or laser coding on the bottle, label, and carton. Expiry dating follows the stability protocol, typically 24 months from production for pectin gummies and 18 months for gelatin.

Cartons are specified to your retail requirements: standard corrugated shippers hold 12, 24, or 48 bottles, with pallet configurations of 48 to 60 cartons per pallet depending on bottle size. We provide dieline templates and can work with your packaging supplier or source bottles and labels locally. For Amazon FNSKU and retail compliance, we can apply FNSKU labels, poly-bag units, and print suffocation warnings where required. We do not apply retail price tags or security tags unless requested. All packaging materials are food-grade and meet EU 10/2011 and US FDA 21 CFR 174-190 requirements for food contact.

Label review is part of the pre-production process. We check your artwork against the target market's requirements for font size, allergen statements, and mandatory warnings. For example, EU labels require the address of the food business operator and a 'not for use by children' warning for melatonin above certain doses. We do not provide legal sign-off, but we flag common issues before printing. Once artwork is approved, we retain a signed proof and a production sample for reference. Packaging changes after approval may incur plate or setup costs, so we recommend finalising labels before mass production begins.

The minimum order quantity for melatonin gummies is 1,000 units per SKU for retail bottling, with lower thresholds for pilot runs subject to formula and packaging availability. Sampling takes 7 to 10 working days after formula confirmation and receipt of your label artwork. Sample costs are quoted per project and credited against the first mass production order. Mass production runs 20 to 35 working days after sample approval and receipt of deposit. These timelines assume standard pectin or gelatin bases and do not include time for new packaging tooling or custom moulds, which can add 10 to 15 working days.

Shipping is arranged by air or sea depending on volume and urgency. Air freight from Guangdong to US or EU airports typically takes 5 to 8 days door-to-door, while sea freight to the US West Coast takes 18 to 25 days and to EU ports 28 to 35 days. We support EXW, FOB Shenzhen or Hong Kong, and DDP terms for buyers who prefer a landed cost. For DDP, we handle customs clearance and duties, but the buyer remains the importer of record for regulatory purposes. We recommend sea freight for orders above 500 kg to reduce per-unit logistics cost.

Documents provided with each shipment include the Certificate of Analysis, Material Safety Data Sheet (MSDS), free-sale certificate, and phytosanitary certificate where applicable. For halal claims, we provide the relevant certificate from the certifying body for the specific batch. We do not provide a certificate of origin unless requested at quotation. Shipping documents are issued within 3 working days of dispatch. We can also coordinate with your freight forwarder or use our nominated forwarder. All shipments are palletised and shrink-wrapped for stability during transit.