Mouth-Dissolving Oral Film Manufacturer for Nutraceutical Brands

EUPHM runs two coating lines for oral films. Each line handles 1,200 to 1,800 square metres per shift, depending on film thickness and formulation. We cast films onto a moving web, dry them in a multi-zone oven, then cut to single-dose strips. Inline vision systems check for bubbles, thickness drift and edge tears. Monthly output is 4–6 million films across both lines. That capacity covers launches and repeat orders without splitting your SKU across suppliers.

We produce monolayer and multilayer films. Multilayer construction lets you separate incompatible actives or control release speed. Common formats include strip films at 22 × 35 mm, square films at 25 × 25 mm, and custom die-cut shapes. Packaging runs on horizontal form-fill-seal machines for single pouches, or strip packs of 5–10 films. We can also fill into compact dispensers. Changeover between SKUs takes 4–6 hours, which keeps small batches practical.

The film base is usually pullulan, hydroxypropyl methylcellulose (HPMC) or a blend. Pullulan gives fast dissolution, often under 30 seconds. HPMC films dissolve in 45–90 seconds and handle higher active loads. We add plasticisers such as glycerol or sorbitol to keep films flexible at 40–60% relative humidity. For taste, we use sucralose, stevia or monk fruit, plus cooling agents like menthol or WS-23. Flavour systems cover mint, berry, citrus, coffee and unflavoured options.

Active loading depends on solubility and particle size. Water-soluble actives such as caffeine, melatonin and vitamin B12 disperse well up to 50 mg per film. Poorly soluble actives need micronisation below 20 microns or emulsification. We can include electrolytes, botanical extracts, CBD isolate and probiotics, though probiotic films require cold-chain stability testing. Every formula is tested for dissolution time, tensile strength, moisture content and uniformity. We run a 3-month accelerated stability study at 40°C and 75% RH before release.

EUPHM operates a GMP-certified facility with ISO 22000 and HACCP systems. Incoming raw materials are quarantined until identity testing passes. In-process checks run every 30 minutes on film weight, thickness and appearance. Finished films are tested for microbial limits, heavy metals, and active content by HPLC. Certificates of analysis accompany every batch. We are FDA-registered for dietary supplements, which supports US market entry. Halal certifications are available on request.

Shipping terms are FOB Shenzhen or Hong Kong, with CIF and DDP options. Sea freight to Los Angeles takes 18–25 days; to Rotterdam, 28–35 days. Air freight is 5–8 days. We provide commercial invoices, packing lists, certificates of origin and health certificates. For first orders, we recommend a 30% deposit and 70% against the bill of lading. Tooling for custom die-cut shapes takes 10–15 working days and costs USD 800–1,500, depending on complexity.

Every oral film batch is tested against a written specification before release. Incoming raw materials are sampled at 100% of containers for identity by FTIR or HPLC, and each active is assayed for potency within a 95.0–105.0% label claim window. Film samples are pulled at coating start, mid-run and end-of-roll to check uniformity of active content across the web. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella, with limits set to the relevant pharmacopoeial or customer specification. Heavy metals are screened by ICP-MS for lead, cadmium, arsenic and mercury.

Disintegration testing follows a defined method: a 2 cm × 2 cm film square is placed on 10 mL of purified water at 37 °C and must disintegrate within 60 seconds without stirring. Film thickness is measured at five points across the roll using a digital micrometer, with a ±5% tolerance against the approved master. Moisture content is checked by loss on drying and must sit within 3.0–6.0% to preserve flexibility and prevent brittleness. Each batch record captures coating weight, drying temperature profile, cutting registration and pouch seal integrity, and is reviewed by QA before the batch is released.

A certificate of analysis accompanies every shipment. It lists batch number, manufacture and expiry dates, active identity and assay results, microbial counts, heavy metals, disintegration time, thickness and moisture, plus the specification range and the pass/fail result for each parameter. Retention samples of every batch are held for the full shelf life plus 12 months at ambient conditions, and accelerated stability samples are stored at 40 °C / 75% RH for 1, 3 and 6 months. Real-time stability at 25 °C / 60% RH is run to 24 months to support the assigned expiry date.

Deviation handling is documented. If a batch falls outside specification, it is placed on hold, an investigation is opened and the customer is notified within two working days with the proposed disposition. Out-of-specification results are not shipped. For customers who require it, we provide the batch record summary and analytical raw data in PDF. Annual product quality reviews summarise batch trends, complaints and change controls, which supports the supplier qualification files that brand owners maintain under 21 CFR 111 or equivalent GMP frameworks.

Mouth-dissolving oral films are packed in four primary formats. The most common is a single-film laminated sachet with a tear notch, filled on a vertical form-fill-seal line at 40–60 pouches per minute. Multi-film formats use a child-resistant or standard screw-cap HDPE bottle with a desiccant canister, typically holding 30 or 60 films. Blister cards with a paper-backed aluminium lidding are available for pharmacy channels, and stick packs suit single-serve sampling. We can print up to eight colours on sachet film and apply variable data for lot and expiry coding.

For US market entry, the label must carry the statement of identity, net quantity of contents, supplement facts panel, ingredient list, directions for use, and the manufacturer or distributor name and address. We do not write regulatory claims, but we do lay out the panel to the artwork you supply and check that the supplement facts values match the approved formula. Lot number and expiry date are inkjet-printed on each sachet or bottle and repeated on the carton. Cartons are specified in 300–350 gsm board with a matt or gloss finish, packed 12–24 units per inner and 48–144 units per export carton.

Pallet specifications are agreed at order confirmation. Standard export pallets are 1200 × 1000 mm or 1200 × 800 mm, stretch-wrapped and corner-boarded, with a maximum height of 1.8 m including the pallet. We print and apply Amazon FNSKU labels, poly-bag units where required, and carton weight and dimension labels for FBA shipments. Retail compliance checks cover barcode scannability to GS1 standards, country of origin marking and allergen declarations. Artwork proofs are signed off before printing, and a pre-production sample is retained for comparison against the production run.

Shelf life is assigned from stability data and is typically 18–24 months when films are kept in the sealed sachet or closed bottle below 25 °C and away from direct sunlight. We can apply a best-before date and a lot code in a format you specify, including Julian date or a customer-defined prefix. For markets that require it, we add the responsible person or importer address to the carton. Packaging changes such as a new sachet size or a switch from bottle to sachet require a short qualification run, usually 1–2 weeks, before the full order is scheduled.

Sampling starts with a formulation brief and a target dose per film. We produce a pilot batch of 1,000 units or fewer for sensory and stability screening, and the sample lead time is 7–10 working days from receipt of actives and approved artwork. If a new flavour or a new active is required, add 3–5 working days for bench development. Sample costs are quoted per project and are credited against the first mass-production order above 10,000 units. Mass production runs 20–35 working days after sample sign-off, depending on film thickness, pouch format and whether printed packaging is new.

Standard MOQ is 1,000 units per SKU for sachet formats and 1,000 bottles per SKU for bottle formats. Pilot runs from 1,000 units are available at a higher per-unit cost to support market testing. Orders above 50,000 units are scheduled across multiple coating runs to protect lead time, and we confirm the production window in writing at PO acceptance. Capacity is held for 14 days after quotation, after which the slot is released. Rush programmes are possible for repeat orders with unchanged specifications, subject to line availability.

We ship under EXW, FOB Shenzhen or Hong Kong, and DDP for customers who prefer a landed-cost quote. Air freight moves 100–300 kg in 5–8 days door to door and suits launch quantities and sample replenishment. Sea freight is cost-effective above 500 kg, with transit of 25–35 days to US west coast ports and 30–40 days to Europe, plus customs clearance. We provide commercial invoice, packing list, certificate of analysis, material safety data sheet, free-sale certificate and, where the destination requires it, a phytosanitary certificate for botanical ingredients.

Documentation is issued within three working days of shipment. The commercial invoice states the Incoterm, HS code and country of origin, and the packing list gives carton count, gross and net weight and pallet dimensions. We can arrange fumigation-free packaging and provide a declaration where the destination country requires it. For DDP shipments, we use a forwarder who handles import clearance and duty, and we share the tracking number and estimated delivery date. Customers receive a pre-shipment photo report of finished cartons and pallet labels before the container is sealed.