Oral Film Manufacturer for Dietary Supplements

The plant casts films on a continuous coating line, then dries and slits them to width. Film thickness is held between 50 and 120 microns. Each strip weighs 30–150 mg. Cutting is done on rotary dies sized to your pouch or blister. Line output is 1.2 million strips per day across two shifts. That covers a 100,000-unit launch order in 8–12 working days once bulk film is released.

Pouching runs on vertical form-fill-seal equipment. Options include single-strip sachets, 5-count and 10-count pouches, and multi-strip cartons. EUPHM can also supply bulk film rolls for brands that fill in their own facility. Bulk rolls ship in 20–35 working days. Retail cartons add 3–5 working days for packaging.

Film base is typically pullulan or hydroxypropyl methylcellulose. Both give a fast dissolve, usually under 30 seconds. Active loading depends on the ingredient. Water-soluble vitamins such as B12 and vitamin C load at 5–25 mg per strip. Botanical extracts and minerals sit lower, often 1–10 mg, because they affect film flexibility. EUPHM tests each formula for tensile strength, moisture and disintegration before scale-up.

Flavour and sweetener systems matter for compliance. Sugar-free films use sucralose, stevia or monk fruit. Natural colours and flavours are available for EU and UK labels. If your target market requires organic certification, the plant can run and EU-organic compliant batches on a segregated line. Vegan films use plant-derived bases only. Halal certificates are issued per finished SKU.

Every batch is tested for identity, potency, microbial limits and heavy metals. The facility is GMP-certified and holds ISO 22000 and HACCP. EUPHM is an FDA-registered facility, which supports US import. Certificates of analysis are issued per lot. Stability testing runs at 25°C/60% RH and 40°C/75% RH for 24 months. Accelerated data is available at 3 and 6 months before retail launch.

Export documents include commercial invoice, packing list, certificate of origin, health certificate and halal certificates where relevant. Air freight samples reach the US in 3–5 days and the EU in 2–4 days. Sea freight for mass production takes 18–30 days depending on port. EUPHM ships from Shenzhen and Hong Kong. Cartons are labelled to your artwork and barcoded for retail.

Every oral film batch is sampled at three points: incoming raw materials, the casting solution before drying, and the finished strip after cutting. Identity testing by FTIR or HPLC confirms each active, while potency assays quantify the marker compound against a validated reference standard. Microbial limits follow USP <2021> and <2022> for non-sterile dietary supplements, with total aerobic count under 1,000 CFU/g and absence of E. coli and Salmonella. Heavy metals are screened by ICP-MS against ICH Q3D thresholds, and disintegration time is measured in purified water at 37°C, typically 15 to 45 seconds depending on film thickness.

A certificate of analysis accompanies each lot and lists batch number, manufacturing date, expiry date, active content as a percentage of label claim, microbial results, heavy metals, moisture content (target 2 to 5 percent), film thickness in microns, and disintegration time. Where a botanical extract is used, the COA also states the extract ratio and marker compound. Retention samples of every batch are held for the full shelf life plus six months, stored at 25°C and 60 percent relative humidity in the original primary packaging.

Stability follows a bracketed protocol: three batches per SKU at 25°C/60 percent RH for 24 months, with accelerated conditions at 40°C/75 percent RH for six months. Tests at 0, 3, 6, 12, 18 and 24 months cover appearance, potency, moisture, microbials and disintegration. Real-time data supports the shelf life printed on the pouch. For export markets requiring a shelf-life statement beyond 24 months, an extended study can be commissioned, though most oral film products are formulated for a 24-month claim.

Oral films are packed in single-dose sachets, multi-film blisters, or HDPE bottles with desiccant. Sachets are the most common for retail: a four-layer laminate of PET, aluminium, nylon and polyethylene gives a moisture barrier below 0.1 g/m²/day. Blisters use a PVC/PVDC or ACLAR film with aluminium lidding. Bottles are 30 ml to 100 ml HDPE with induction seals and child-resistant caps where required. Cartons are printed on 350 gsm FBB with matt or gloss lamination, and pallet configuration is standard 1,200 x 1,000 mm or 1,200 x 800 mm depending on destination.

Labels for the US market carry the FDA dietary supplement panel: supplement facts, serving size, active ingredients with percent daily value where established, other ingredients, and the mandatory disclaimer. Lot number and expiry date are inkjet-printed on the sachet or bottle base in a format agreed at artwork stage. For EU retail, the label includes the nutrition declaration, allergen statement and the address of the responsible person. We do not write label copy, but we check artwork against the approved formula and flag mismatches before printing.

Amazon FNSKU labels are applied at the sachet or carton level, and we can print and apply them in-house to avoid a third-party prep centre. Retail compliance checks cover barcode scannability (GS1-128 or UPC-A), net quantity statement, and country-of-origin marking. For club-store or pharmacy chains, we provide a packaging specification sheet with dimensions, material weights and a dieline. Typical packaging lead time is 10 to 15 working days after artwork approval, running in parallel with production.

Sampling starts with a formulation brief and a target dose per strip. We produce a pilot batch of 200 to 500 strips for sensory and stability screening, with a sample lead time of 7 to 10 working days. If a new flavour or active is required, add 5 working days for bench work. Samples are sent by courier with a preliminary COA and a packaging mock-up. Client feedback on mouthfeel, dissolve time and taste is incorporated before the pilot is scaled to a commercial batch.

Mass production runs 20 to 35 working days after sample approval and receipt of packaging materials. The window depends on film thickness, active loading and whether the project needs a stability study before release. For repeat orders with approved artwork and existing raw materials, production can be 15 to 20 working days. We schedule in weekly casting slots and confirm the date in the proforma invoice. Delays are communicated within 48 hours, with a revised date and reason.

Shipping terms are EXW, FOB Shenzhen or Hong Kong, and DDP for select destinations. Air freight suits pilot or urgent retail replenishment at 5 to 8 days door to door, while sea freight is 25 to 35 days to US west coast and 30 to 40 days to Europe. Documents provided with each shipment include commercial invoice, packing list, COA, MSDS, free-sale certificate, and a phytosanitary certificate where a botanical ingredient requires one. Certificate of origin can be issued on request for preferential tariff treatment.