Sleep Support Gummy Manufacturer

EUPHM operates two gummy lines with a combined output of 1.2 million units per day. The lines handle pectin, gelatin and starch-based bases. For sleep support, pectin is common because it is vegan and stable at room temperature. Gelatin offers a chewier texture but is not suitable for halal or vegetarian claims. We run both, so you can match the base to your target market.

Depositing accuracy is ±2% for active ingredients. That matters for melatonin, where overages are costly and underages risk label claims. We dose actives into the base after cooling to below 40°C, which protects heat-sensitive ingredients like L-theanine and chamomile extract. Gummies are cured for 24–48 hours, then coated with oil or wax to prevent sticking. Retail bottling uses 60 cc, 120 cc or 250 cc HDPE bottles with child-resistant caps.

Melatonin is the most requested active. Typical doses are 1 mg, 3 mg, 5 mg and 10 mg per gummy. Melatonin degrades above 50°C, so we add it at the final stage. L-theanine is stable but bitter; we mask it with berry, citrus or tropical flavours and a tartaric acid blend. Magnesium glycinate and magnesium citrate can be dosed at 50–100 mg per gummy, though higher loads affect texture. GABA and valerian root extract are also common.

Sugar-free options use maltitol, xylitol or allulose. Allulose has the closest mouthfeel to sucrose but costs more. For organic claims, we source USDA-certified organic tapioca syrup and organic fruit powders. Natural colours come from black carrot, spirulina and turmeric. We test every batch for potency, and we provide a certificate of analysis before shipment. Stability testing runs at 25°C/60% RH and 40°C/75% RH for 3–6 months.

The facility is GMP-certified and FDA-registered. We hold ISO 22000 and HACCP certifications. Halal certificates are available for specific SKUs. Each shipment includes a certificate of analysis, a certificate of origin and a safety data sheet. For EU clients, we provide documentation for novel food and health claim compliance. For the Middle East, we can arrange halal certification through recognised bodies.

Shipping is by air or sea from Shenzhen or Hong Kong. Air freight takes 3–7 days to the US or EU; sea freight takes 18–30 days. We handle export clearance and can ship under DDP terms. MOQ for repeat orders is 1,000 units per SKU. Private label clients get full artwork support, including dieline templates and regulatory review. Payment terms are 30% deposit, 70% before shipment.

Every sleep gummy batch is sampled at three points: incoming raw materials, in-process gummy mass before depositing, and finished product after curing. Identity testing by FTIR confirms melatonin, L-theanine, GABA and botanical extracts against reference spectra. Potency is assayed by HPLC, with melatonin typically tested at 95–105% of label claim. Microbial testing covers total aerobic count, yeast and mould, E. coli, Salmonella and Staphylococcus aureus, with results available within five working days. Heavy metals (lead, cadmium, arsenic, mercury) are tested by ICP-MS to meet EU and US pharmacopoeial limits.

Disintegration testing follows USP <701> for gelatin gummies and internal methods for pectin, ensuring the product breaks down within 30–60 minutes. Each batch has a retention sample of at least 200 g stored at 25°C/60% RH and 30°C/65% RH for the shelf life plus 12 months. Stability protocols include 0, 3, 6, 12, 18 and 24-month timepoints, with accelerated testing at 40°C/75% RH for three months. Melatonin and heat-sensitive actives are monitored for degradation, and any batch falling below 90% of label claim at the 12-month point triggers a formulation review.

The certificate of analysis (COA) issued for each batch lists batch number, production date, expiry date, appearance, fill weight, pH, potency of each active, microbial results, heavy metals, disintegration time and a statement of conformity. COAs are available in English and can be customised for your quality team. We also provide a master batch record summary and deviation reports where applicable. Documentation is released within 48 hours of batch completion, and electronic copies are sent by email with hard copies included in the shipment.

For sleep gummy manufacturing, we hold retention samples for every SKU for two years after expiry. Stability chambers are monitored continuously with calibrated data loggers, and calibration certificates are available on request. If you require third-party testing at an external laboratory, we can arrange it at cost and include the report in the batch file. Our quality system is audited annually under GMP and ISO 22000, and we welcome customer audits with 14 days' notice.

Sleep gummies can be packed in HDPE bottles (60, 90, 120 or 180 count), PET jars, blister packs, stick packs or single-serve sachets. Bottles are induction-sealed and fitted with child-resistant caps where required. Common bottle sizes are 60 cc, 100 cc and 150 cc, with labels applied at up to 120 bottles per minute. Blister packs use PVC/PVDC or alu-alu for moisture protection. Stick packs are typically 5 g to 10 g fill and are suited to single-dose melatonin or magnesium blends. We can supply desiccant sachets and cotton coils on request.

For the US market, labels must include a Supplement Facts panel with serving size, active ingredients and % Daily Value where applicable, plus a list of other ingredients, allergen statement, net quantity, direction of use and the manufacturer/distributor address. We can format labels to FDA 21 CFR 101 requirements and review artwork for compliance. Lot and expiry coding is applied by inkjet or laser, with formats such as LOT YYMMDD and EXP YYMM. We recommend a 24-month shelf life for most sleep gummies, supported by stability data.

Cartons are standard export-grade corrugated, with 12, 24 or 48 bottles per carton depending on bottle size. Pallet specifications can be tailored to your retailer: standard 1200 x 1000 mm or 1200 x 800 mm pallets, stretch-wrapped and labelled with SSCC codes. For Amazon FNSKU and retail compliance, we can print and apply FNSKU labels, poly-bag units, and pack to Amazon's prep requirements. We also provide carton markings for Walmart, Costco and EU retailers on request.

Retail-ready packaging includes tamper-evident seals, lot codes on both bottle and carton, and expiry dates in the required format. We can source bottles, caps and labels from approved suppliers or use your nominated packaging. Artwork proofing takes 3–5 working days, and we provide digital proofs and physical samples before mass production. Packaging line capacity is up to 30,000 bottles per shift, and we can handle shrink-wrapping, display-ready cases and multi-packs for club stores.

Sample orders for sleep gummies start at 500 units per SKU, with a sample lead time of 7–10 working days after formula and packaging approval. Samples are produced on the same line as mass production, so they reflect the final product. We provide up to three free samples per SKU, with the buyer covering courier costs. For custom formulations, a development fee applies, which is credited against the first production order. Sample feedback is reviewed within 48 hours, and we can adjust flavour, texture or potency before scaling up.

Mass production lead time is 20–35 working days from receipt of purchase order, deposit and approved artwork. This includes raw material procurement, production, quality testing and packaging. If you need faster turnaround, we can expedite to 15–20 working days subject to line availability and raw material stock. Production capacity is up to 1.2 million gummies per day across two shifts, so we can handle repeat orders and seasonal peaks. We recommend booking capacity 6–8 weeks ahead for Q4 shipments.

We offer EXW, FOB Shenzhen or Hong Kong, and DDP for most major markets. Air freight is typically 5–8 days door-to-door and is suitable for samples and urgent orders up to 500 kg. Sea freight is 25–40 days depending on destination and port, and is cost-effective for full container loads (FCL) or less than container loads (LCL). We provide a packing list, commercial invoice, bill of lading, COA, MSDS, free-sale certificate and, where relevant, phytosanitary certificates for botanical ingredients. All documents are issued within 3 working days of shipment.

For DDP shipments, we handle customs clearance and duties in the destination country, with delivery to your warehouse or Amazon fulfilment centre. We can also arrange cargo insurance at 110% of invoice value. Payment terms are 30% deposit with balance against bill of lading, or irrevocable L/C at sight for orders above USD 50,000. We recommend booking sea freight at least 4 weeks before your required delivery date to avoid peak-season surcharges.