Multi-Layer Tablet Manufacturer for Global Brands

Our rotary presses run two or three independent feed hoppers, each delivering a separate granulation into the die. The first layer is pre-compressed, the second and third are added and compressed again, then the final tablet is ejected. This avoids cross-contamination between layers and holds layer weight to within ±5% of target. We run bi-layer tablets from 6 mm to 22 mm in diameter and tri-layer from 8 mm to 20 mm. Core weight and total weight are checked every 15 minutes during the run.

Tooling is changeable, so the same line handles round, oval, oblong and custom shapes. We can also produce multi-layer tablets with a functional coating after compression. If your formula has one heat-sensitive or moisture-sensitive ingredient, we can place it in a separate layer to reduce degradation during storage. Production capacity is 1.2 million tablets per shift across two suites, which suits both launch volumes and repeat orders.

Multi-layer tablets are useful when two actives cannot sit in the same granulation. Examples include a mineral and a vitamin with opposing pH stability, or a probiotic blend and a herbal extract. We test each layer separately for flow, compressibility and moisture before compression. If one layer needs a sustained-release matrix and the other needs immediate release, we adjust the binder and disintegrant system per layer rather than compromising the whole tablet.

For botanicals, we work with standardised extracts and can include 50–800 mg per layer. For vitamins and minerals, common layer loads are 10–500 mg. We also produce multi-layer tablets with a placebo layer for blinding in clinical or sensory trials. Every formula is reviewed for compatibility before we quote. If a two-layer design is not technically feasible, we will say so and propose a single-layer or capsule alternative.

EUPHM operates a GMP-certified facility with ISO 22000 and HACCP. The site is FDA-registered. halal and vegan certifications are available depending on the ingredient list and target market. We test each batch for weight variation, hardness, friability, disintegration and micro counts. Certificates of analysis are issued per batch. For the EU, we can provide documentation to support health claims only where authorised; we do not make drug claims.

Retail bottling runs from 30 to 120 count per bottle. Bulk tablets are packed in double polyethylene bags inside fibre drums. Lead time for mass production is 20–35 working days after formula and artwork approval. We ship from Shenzhen and Hong Kong ports. Air freight is available for pilot runs. We handle documentation for the US, EU, UK and Middle East, including halal certificates where required.

Every multi-layer tablet batch is tested against a written specification before release. Incoming raw materials are sampled and checked for identity by FTIR or HPLC, potency by assay, microbial limits (total aerobic count, yeast and mould, E. coli and Salmonella), heavy metals (lead, cadmium, arsenic, mercury by ICP-MS), and where relevant pesticide residues. In-process checks run at defined intervals during compression: layer weight, total weight, thickness, hardness, and friability, with results recorded against the batch record. Finished tablets are tested for potency, uniformity of content, disintegration, and dissolution where a release profile is claimed.

A certificate of analysis (COA) accompanies each batch and states the product name, lot number, manufacture and expiry dates, specification limits, test methods, and measured results with pass or fail status. Where a customer requires it, the COA is signed by the quality manager and linked to the retained sample. Retention samples from every batch are stored under controlled conditions for the shelf life plus twelve months, so any later query can be checked against the original material. Stability testing follows a bracketed protocol: typically 0, 3, 6, 12, 18 and 24 months at 25°C/60% RH, with accelerated conditions at 40°C/75% RH for six months, using the same blister or bottle format supplied to the customer.

For multi-layer tablets the additional risk is layer adhesion and moisture migration between layers. We include a layer bond check by visual and manual inspection after defined storage intervals, and record any separation or cracking against acceptance criteria. Disintegration testing is performed on the whole tablet and, where relevant, observed layer by layer. Microbial testing is done on the finished product rather than only on raw materials, because compression and packaging can introduce contamination. If a batch fails any specification, it is placed on hold, investigated, and either reworked under a documented protocol or rejected; the customer is notified before any disposition decision.

Multi-layer tablets can be packed in HDPE bottles with induction seals and child-resistant or standard caps, in PVC/PVDC or aluminium blister packs, in stick packs, or in sachets for single-dose formats. Bottle sizes typically run from 30 to 180 counts, with desiccant where the formulation is moisture-sensitive. Blister tooling is custom-made for the tablet dimensions, so a bi-layer oval requires its own cavity; allow two to three weeks for tooling before the first packaging run. Stick and sachet formats suit powder or smaller tablets and are filled on separate lines, so they are quoted as a distinct packaging option rather than a variation of the bottle line.

For the US market, labels must carry the FDA dietary-supplement panel elements: a statement of identity, net quantity of contents, supplement facts panel with serving size and percent daily value where established, ingredient list in descending order of predominance, and the name and place of business of the manufacturer, packer or distributor. Allergen declarations, if applicable, and the required 'Keep out of reach of children' and storage statements are checked at artwork approval. Lot and expiry coding is applied by inkjet or laser on the bottle, blister or carton, with the format agreed in writing before production; we do not change coding formats without a signed approval.

Cartons are specified with dimensions, board grade, and print colours, and pallets are built to a stated pattern with stretch wrap and corner boards. For Amazon sellers we can apply FNSKU labels and poly-bag the units to the marketplace's requirement, and we can print carton markings to the retail compliance standard the customer supplies. We do not hold a retail account ourselves, so the customer remains the seller of record and is responsible for the accuracy of claims on the label. Artwork proofs are sent as PDFs for sign-off, and no packaging run starts until the approved proof is on file.

Sampling for a multi-layer tablet starts with formula and layer design, then a pilot compression run. Sample lead time is typically 7 to 10 working days from receipt of the signed formula brief and any customer-supplied actives, assuming standard excipients are in stock. If a new blister tool or a custom tablet shape is required, add two to three weeks. Samples are sent with a preliminary COA and a packaging mock-up where requested, and the customer is asked to confirm hardness, disintegration and appearance before mass production is scheduled.

Mass production runs 20 to 35 working days after formula approval, depending on layer count, packaging format and whether the actives are customer-supplied or sourced by us. A tri-layer tablet with three release profiles takes longer than a simple bi-layer because each layer is compressed and checked in sequence. The production window is confirmed in writing once the purchase order and deposit are received. We do not quote a fixed date before the formula is locked, because changes to the formulation reset the process validation steps.

Shipments are made by air or sea depending on volume and urgency. Air freight is typically used for samples and for orders under about 200 kg, with transit of 5 to 10 days to major hubs; sea freight is used for pallet quantities, with transit of 25 to 40 days to Europe and 20 to 35 days to the US west coast. We quote EXW, FOB and DDP terms; DDP is available for select destinations where our forwarder can clear customs. Documents provided with each shipment include the COA, MSDS, free-sale certificate, and, where the destination requires it, a phytosanitary certificate or certificate of origin. The customer is responsible for import licensing and for confirming that the product is permitted in the destination market.