Enteric-Coated Softgel Manufacturer for Targeted Release

EUPHM operates enteric coating lines with an annual capacity of 1.2 billion softgels. We apply acrylic-based and cellulose-based coatings to achieve resistance in simulated gastric fluid for up to 2 hours. Coating thickness is controlled to 3–8% weight gain, depending on the fill. This range balances acid resistance with intestinal release. Our lines run 24 hours a day, 6 days a week, with changeover times under 4 hours. That schedule supports repeat orders and seasonal demand spikes without long waits.

For pilot runs, we produce batches as low as 1,000 units to test coating uniformity and release profiles. Scale-up to commercial volumes follows a documented process. We monitor coating pan speed, inlet air temperature, and spray rate every 15 minutes. These parameters are logged for each batch. If you need a specific release profile, our team can adjust the coating polymer or weight gain. We also offer dual-layer coating for moisture-sensitive fills. This capability is part of our broader /softgel-manufacturer services, which include standard, chewable, and enteric softgels.

Enteric coating works best with fills that are solid or semi-solid at room temperature. Common actives include probiotics, pancreatic enzymes, bromelain, and fish oil. For probiotics, we use a low-moisture fill matrix to maintain CFU counts through coating and drying. We test viability after coating and at 6-month intervals. For enzymes, we select coating polymers that dissolve at pH 5.5 or higher. This prevents premature release in the stomach. We also offer enteric softgels with delayed-release omega-3s to reduce fishy burps.

Not every ingredient suits enteric coating. Oils with high free fatty acid content can interact with the coating. We run compatibility trials before quoting. Our lab tests acid resistance using USP <711> and <724> methods. If a fill fails, we suggest alternatives such as esterified oils or microencapsulation. We also check for interactions between the coating and the gelatin shell. For vegan options, we use HPMC shells with enteric coatings. All formulations are developed in our R&D lab in Guangdong, with a turnaround of 10–15 working days for a prototype.

Every enteric softgel batch undergoes release testing for acid resistance, disintegration, and fill weight. We test 10 softgels per batch in simulated gastric fluid for 2 hours, followed by intestinal fluid for 60 minutes. The acceptance criteria are no more than 10% release in acid and at least 80% release in intestinal fluid. We retain samples for 24 months. Our facility is GMP-certified, ISO 22000, and HACCP compliant. We also hold halal, and certifications. For vegan enteric softgels, we provide vegan certification on request.

Documentation includes certificates of analysis, batch records, and stability data. We provide these within 5 working days of batch completion. For US buyers, we operate as an FDA-registered facility. We do not claim FDA approval. For EU buyers, we follow EU GMP Annex 1 where applicable. Shipping from Guangdong to Los Angeles takes 18–22 days by sea, and 5–7 days by air. We handle customs documentation for the US, EU, UK, and Middle East. Our quality team can join your audit via video or in person.

Every enteric softgel batch is tested against a written specification before release. Incoming raw materials are checked for identity by FTIR and assay by HPLC. During production, we monitor fill weight, seam thickness, and coating weight gain at intervals of 30 minutes. After drying, finished softgels are tested for appearance, disintegration in 0.1N HCl for 2 hours followed by phosphate buffer at pH 6.8, microbial limits (TPC, yeast and mould, E. coli, Salmonella), heavy metals (lead, cadmium, arsenic, mercury), and potency of the active ingredient. Testing follows USP methods where applicable, and we retain samples from every batch for 24 months.

A certificate of analysis (COA) is issued for each batch. It lists the product name, lot number, manufacturing date, expiry date, and results for all tests performed, including the specification range and the actual result. For enteric softgels, the COA includes disintegration time in acid and buffer, coating uniformity, and any relevant potency or marker compound results. We also provide a statement of composition, allergen declaration, and country of origin. If your market requires additional tests, such as residual solvents or specific pesticide screens, these can be added to the protocol at the quotation stage.

Retention samples are stored under controlled conditions (25°C/60% RH and 30°C/65% RH) for the shelf life of the product plus 12 months. Stability studies follow ICH guidelines: accelerated at 40°C/75% RH for 6 months and long-term at 25°C/60% RH for up to 36 months, depending on your claim. We test at 0, 3, 6, 9, 12, 18, 24, and 36 months for appearance, disintegration, potency, and microbial limits. These data support your shelf-life declaration and are available in a stability summary report for regulatory submissions.

Documentation is handled under a change-control system. Any deviation from the batch record is investigated and documented before release. We provide batch records for review during audits, and we can supply a certificate of free sale and a GMP certificate for your registration. Our quality team responds to technical queries within two working days, and we can arrange third-party testing at an accredited laboratory if your market requires independent verification.

Enteric softgels are moisture-sensitive, so packaging must provide an effective barrier. We offer HDPE bottles (30, 60, 90, 120, and 180 count) with induction seals and child-resistant closures, as well as blister packs (PVC/PVDC or alu-alu) and single-dose sachets. For stick packs, we use a foil laminate with a moisture barrier. Bottle fill is by automatic counter with a accuracy of ±1 unit. We can apply desiccant canisters or silica gel sachets if your stability data support it. Cartons are printed to your artwork with lot number and expiry date inkjet-coded on the bottle and carton.

For the US market, we follow FDA dietary supplement labelling requirements: statement of identity, net quantity of contents, supplement facts panel with serving size and percent daily value, ingredient list, and allergen declaration. We also include the mandatory disclaimer for structure/function claims. For the EU, we apply Regulation (EU) No 1169/2011 and the Food Supplements Directive. We can generate a label proof for your approval and check it against your market's requirements before printing. Lot and expiry coding is done at the filling line, and we retain a coding record for each batch.

Carton and pallet specifications are tailored to your distribution. Standard export cartons are 5-ply corrugated with a test strength of 32 ECT, and we print your SKU, lot, expiry, and quantity on two sides. Pallets are 1,200 x 1,000 mm or 1,200 x 800 mm, stretch-wrapped and strapped, with a maximum height of 1,800 mm. We can apply Amazon FNSKU labels and overboxing for FBA shipments, including polybagging and suffocation warning labels. For retail chains, we can provide a GS1-128 pallet label and an advance shipping notice (ASN).

Retail readiness also covers artwork compliance. We check that your label includes the correct supplement facts format, country of origin, and any required warnings. For Amazon, we ensure that the product is sealed and labelled with the FNSKU and that the carton meets Amazon's weight and size limits. We can also provide a digital asset pack with product images and label files for your listing. If you need a retail-specific pack, such as a club-store multi-pack, we can design the packaging accordingly.

The minimum order quantity for enteric-coated softgels is 1,000 units per SKU for retail bottling. For pilot runs, we can go lower, typically 1,000 units, but this depends on the softgel size and coating requirements. Samples are produced in 7 to 10 working days after we receive your formula and specifications. Sample costs are quoted separately and are usually credited against the first production order. We provide a sample approval form to confirm appearance, weight, and disintegration before mass production.

Mass production takes 20 to 35 working days after sample approval and receipt of your purchase order and deposit. This window includes raw material procurement, softgel encapsulation, enteric coating, drying, and packaging. If your order requires custom tooling, add 15 to 20 working days for tooling fabrication. We update you weekly on production status and provide a pre-shipment inspection report before dispatch. For repeat orders, lead time can be reduced to 15 to 25 working days if raw materials are in stock.

We ship from Shenzhen or Hong Kong ports. Air freight takes 3 to 7 days to major hubs, and sea freight takes 20 to 35 days depending on destination. We offer EXW, FOB, and DDP terms. For DDP, we handle customs clearance and delivery to your door, but you are responsible for import duties and taxes unless agreed otherwise. We provide a commercial invoice, packing list, bill of lading, COA, MSDS, and certificate of free sale. For plant-based products, we can arrange a phytosanitary certificate if your market requires it.

We recommend booking shipping space at least two weeks before production completion to avoid delays. For urgent orders, we can arrange air freight with a 48-hour booking notice, subject to airline space. All shipments are palletised and shrink-wrapped, and we can provide photos of the pallet before dispatch. Our logistics team coordinates with your freight forwarder or uses our own partners. We also offer a drop-ship option to your 3PL warehouse in the US or EU, with FNSKU labelling and ASN.