Film-Coated Tablet Manufacturer for Global Brands

EUPHM operates two film-coating lines with 65cm and 90cm pans. Batch sizes range from 50kg to 500kg, covering pilot runs and commercial volumes. We apply aqueous and solvent-based coatings, including Opadry, Kollicoat, and enteric polymers like Eudragit. Coating uniformity is monitored by weight gain and visual inspection. Typical coating weight gain is 2–4% for immediate release and 5–8% for enteric. Line capacity reaches 1.2 million tablets per day across two shifts.

Our coating parameters are recipe-controlled: inlet air temperature 40–70°C, pan speed 4–12 rpm, spray rate 20–80 g/min. These ranges are adjusted per formulation. We handle tablet cores from 200mg to 1,500mg, with hardness above 4 kp to withstand coating stress. For sustained-release coatings, we use ethylcellulose or acrylic polymers. All coating runs include in-process checks every 15 minutes for weight gain, appearance, and disintegration.

Film coating is not one-size-fits-all. EUPHM formulates coatings for moisture-sensitive actives like probiotics, vitamins, and herbal extracts. We use hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol (PVA), and titanium dioxide-free options for clean-label projects. For bitter actives such as berberine or green tea extract, we apply a seal coat followed by a colour coat. Coatings can be clear, white, or custom Pantone-matched. We also offer enteric coatings for delayed release in the small intestine.

Ingredient compatibility is tested before production. We run binary compatibility studies for the active and coating polymer. For hygroscopic actives, we recommend a moisture barrier coating with low water vapour permeability. For light-sensitive ingredients, we use opaque coatings with iron oxides or natural pigments. EUPHM maintains a library of 40+ coating formulations. Custom development takes 10–15 working days, including stability checks at 40°C/75% RH for 1 month.

Every film-coated tablet batch is tested for appearance, weight variation, hardness, disintegration, and dissolution. We follow USP <711> and <701> methods. Coating uniformity is verified by weight gain and colour consistency. Our QC lab runs HPLC, UV-Vis, and dissolution apparatus. Batch records are retained for 5 years. EUPHM is a GMP-certified facility, ISO 22000 and HACCP certified. We are FDA-registered for dietary supplements. halal and vegan certifications are available on request.

For export to the US, EU, UK, and Middle East, we provide certificates of analysis (CoA), certificates of origin, and health certificates. Our documentation supports customs clearance and retailer audits. We also offer stability testing under ICH conditions: 25°C/60% RH and 40°C/75% RH for 3, 6, and 12 months. Lead time for full stability studies is 20–35 working days. EUPHM does not claim FDA approval; we are an FDA-registered facility.

Every film-coated tablet batch is tested at three stages: incoming raw materials, in-process core tablets before coating, and finished coated tablets. Identity testing by FTIR or HPLC confirms each active, while potency assays quantify the active to within 95.0–105.0% of label claim. Microbial limits follow USP <61> and <62> or Ph. Eur. 2.6.12/2.6.13, with total aerobic count under 10³ CFU/g and absence of E. coli and Salmonella. Heavy metals are screened by ICP-MS against ICH Q3D limits, and disintegration testing is performed on six tablets per batch in water at 37°C, with immediate-release cores required to disintegrate within 15 minutes.

In-process controls during coating include weight gain monitoring (target 2–5% for immediate-release films), pan inlet and exhaust temperatures logged every 15 minutes, and spray rate checks. After coating, batches are sampled for appearance, film adhesion, and colour uniformity against an approved reference. Dissolution testing runs on six or twelve tablets at the client-specified method, typically USP Apparatus 2 at 50–75 rpm in 900 mL medium. Any out-of-specification result triggers a documented investigation before release, and the batch is placed on hold until the deviation is closed.

The certificate of analysis (COA) issued with each batch lists batch number, manufacturing date, expiry date, and test results for appearance, identification, potency, uniformity of dosage units, disintegration, dissolution, microbial limits, and heavy metals where applicable. Clients receive the COA in PDF alongside the batch record summary. Retention samples of each batch are stored at 25°C/60% RH and 30°C/65% RH for the full shelf life plus 12 months, in the same packaging as the commercial lot, so future investigations can reference the original condition.

Stability protocols follow ICH Q1A(R2). Accelerated testing runs for six months at 40°C/75% RH with points at 0, 1, 2, 3, and 6 months, while long-term testing continues at 25°C/60% RH or 30°C/65% RH for 12 to 24 months depending on the claimed shelf life. Parameters tested at each point include potency, dissolution, moisture, microbial limits, and appearance. For enteric-coated tablets, acid resistance is added at the 2-hour mark in 0.1N HCl. Stability data packages are available for client review before commercial release.

Film-coated tablets can be packed in HDPE bottles with induction seals and child-resistant or standard caps, in PVC/PVDC or alu-alu blisters, in stick packs, or in single-dose sachets. Bottle sizes range from 30cc to 500cc, with counts from 30 to 300 tablets. Blister cavities are formatted to the tablet dimensions, typically 8–12 mm diameter for round cores and up to 20 mm for oblong shapes. Stick packs are suited to 1–2 tablet formats and use foil laminate with a tear notch. Moisture-sensitive actives should specify alu-alu blisters or HDPE bottles with desiccant.

Labels are prepared to the destination market's requirements. For US dietary supplements, the label carries the Supplement Facts panel with serving size, amount per serving, % Daily Value where applicable, other ingredients, and the mandatory domestic address or phone number for the distributor. EU labels require nutrition declaration, allergen statements, and the food business operator address. Lot number and expiry date are inkjet-printed on the bottle, blister foil, or carton, with format matching the client's specification (for example LOT 12345, EXP 2027-06).

Cartons are specified in 300–400 gsm board with client artwork, and each carton carries a lot and expiry code plus a barcode (EAN-13 or UPC-A). Shippers are 5-ply corrugated with a maximum gross weight of 15–20 kg for manual handling. Pallets are 1,200 x 800 mm or 1,200 x 1,000 mm, stretch-wrapped and strapped, with 40–60 cartons per pallet depending on carton size. Pallet labels show SKU, lot, quantity, and gross weight.

For Amazon and retail compliance, we apply FNSKU labels on each unit and poly-bag units where required, with suffocation warning text printed on the bag. We can print and apply retail-ready labels, including GS1 barcodes, and provide carton-level cartonisation data such as dimensions and weight per carton. We do not provide Amazon account services, but we pack to the FBA inbound requirements the client supplies, including carton weight limits and label placement.

The standard MOQ for film-coated tablets is 1,000 units per SKU, and pilot runs can be lower on request. Sample production takes 7–10 working days from approved formula and artwork, and includes coating, packing in client-specified packaging, and a COA. Mass production runs 20–35 working days after sample approval and receipt of packaging materials. Delays in artwork approval or packaging delivery extend the window, so we confirm the critical path in writing at order acceptance.

Shipments are arranged by air or sea depending on volume and urgency. Air freight typically moves 100–500 kg in 5–10 days door to door, while sea freight suits 500 kg and above with 25–40 days transit depending on destination port. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for select markets. Incoterms are stated on the proforma invoice, and we confirm the named place and risk transfer point before booking.

Documents provided with each shipment include the commercial invoice, packing list, certificate of analysis per batch, material safety data sheet where applicable, and a free-sale certificate for markets that require it. Phytosanitary certificates are not applicable to film-coated tablets but can be arranged for herbal raw materials where the destination requires them. Certificates of origin can be issued on request. We do not provide regulatory registration in the destination country; that remains the brand owner's responsibility.

For repeat orders, we hold approved artwork and batch records on file, which shortens the next production cycle. We recommend booking capacity four to six weeks ahead during peak seasons, particularly Q3 and Q4 when retail replenishment demand rises. Payment terms are typically 30% deposit with balance against copy of shipping documents, and we confirm the schedule in the proforma invoice before production begins.