Enteric Capsule Manufacturer for Dietary Supplements

We run two enteric formats. First, enteric-coated hard capsules: the capsule shell is coated with a polymer that resists gastric fluid for up to 2 hours. Second, capsules filled with enteric-coated pellets: the pellets are coated first, then filled into a standard or vegetarian capsule. Both routes are produced on automated lines with in-process weight and coating thickness checks. We can coat up to 300,000 capsules per batch.

For pellet-filled capsules, we use fluid-bed coating with Eudragit or cellulose-based polymers. Coating weight gain is typically 8-15% depending on the active. You can choose a single-layer or dual-layer coat. We test disintegration in simulated gastric fluid (0.1N HCl, pH 1.2) and simulated intestinal fluid (pH 6.8). Release profiles are documented per batch. If your formula needs a specific pH trigger, we adjust the polymer ratio at pilot scale.

Not every ingredient suits enteric delivery. Probiotics like Lactobacillus and Bifidobacterium benefit because the capsule bypasses stomach acid. Enzymes such as bromelain and pancreatin also work well. Compounds that irritate the stomach, including NSAIDs, potassium chloride, and some plant extracts, are common candidates. We review your active's pH stability, moisture sensitivity, and dose per capsule before quoting. If enteric is not suitable, we say so.

We can combine enteric pellets with immediate-release granules in the same capsule for biphasic release. Excipients include microcrystalline cellulose, magnesium stearate, and silicon dioxide. For vegan capsules, we use HPMC shells. For halal projects, we source certified shells and document the supply chain. Organic projects require USDA organic or EU organic certification for every ingredient, and we schedule those runs separately to avoid cross-contact.

Every enteric batch is tested for disintegration, coating uniformity, and moisture content. We hold GMP, ISO 22000, and HACCP certifications. Our facility is FDA-registered for dietary supplements. Third-party lab testing is available for potency, heavy metals, and microbial limits. We keep retain samples for 2 years. Batch records and certificates of analysis are provided before shipment. For US and EU clients, we can arrange testing through local labs.

Shipping is from Shenzhen or Hong Kong. We handle export documents, certificates of origin, and halal certificates. Air freight takes 5-8 days to the US or EU; sea freight takes 18-25 days. MOQ is 1,000 units per SKU for retail bottling. Pilot runs start at 1,000 units. Packaging options include HDPE bottles, blister packs, and bulk bags. We label in English, Arabic, or French. Lead time for mass production is 20-35 working days after sample approval.

Every enteric capsule batch is tested against a written specification before release. Incoming raw materials are checked for identity by FTIR and assay by HPLC where applicable. During encapsulation, in-process checks cover capsule weight variation at ±5%, fill weight, and visual defects at a sampling rate of one capsule per 1,000. After coating or pellet filling, we test enteric performance using USP <701> disintegration testing in simulated gastric fluid for two hours followed by simulated intestinal fluid, with a specification of no release in acid and full release within 60 minutes at pH 6.8.

Finished-product testing includes potency by HPLC or microbiological assay for probiotics, microbial limits (total aerobic count, yeast and mould, E. coli, Salmonella), heavy metals by ICP-MS against EU and US limits, and moisture content. We retain samples from every batch for 24 months at controlled conditions. Stability protocols follow ICH Q1A(R2) with accelerated conditions at 40°C/75% RH for six months and long-term at 25°C/60% RH for 24 months, with testing at 0, 3, 6, 12, 18, and 24 months.

A certificate of analysis (COA) is issued per batch and includes the product name, batch number, manufacturing date, expiry date, specification results for each test, and the analyst and QA sign-off. We also provide a statement of composition, allergen declaration, and a non-GMO statement where required. Batch records and analytical raw data are retained for five years and are available for audit by appointment. If a specification is not met, the batch is quarantined and an out-of-specification investigation is opened before any disposition decision.

Enteric capsules are moisture and acid sensitive, so packaging must provide a barrier. We offer HDPE bottles with induction seals and desiccant, blister packs with aluminium lidding, stick packs, and sachets. Bottle sizes range from 30 to 180 capsules. Blister cards can be printed with a maximum of six colours. For stick packs, fill weights are typically 2 to 5 g. We can apply child-resistant closures and tamper-evident bands on request. Carton board is 300 to 350 gsm with a maximum print area of 250 x 180 mm.

For the US market, we set up labels to include the supplement facts panel, serving size, amount per serving, percent daily value where applicable, other ingredients, and the mandatory allergen statement. We also add the domestic address and phone number of the distributor, net quantity, and the disclaimer for structure/function claims. Lot and expiry coding is applied by inkjet or laser at the filling line, with a format agreed in the packaging specification. We do not print claims that require notification unless you provide the substantiation and regulatory sign-off.

For retail and e-commerce, we can apply Amazon FNSKU labels, poly-bag units, and prepare cartons to Amazon's prep requirements. Cartons are typically 5-ply corrugated with a maximum weight of 20 kg. Pallet specifications follow standard 1200 x 1000 mm or 1200 x 800 mm footprints, with stretch wrap and edge protectors. We provide a packing list and pallet manifest for each shipment. If you sell in the EU, we can include the responsible person address and the EC declaration where the product is a food supplement.

Our standard MOQ for enteric capsules is 1,000 units per SKU, with lower quantities accepted for pilot runs subject to a setup fee. Samples are produced in 7 to 10 working days after formulation and packaging specifications are approved. Sample quantities are typically 100 to 300 capsules. Mass production runs 20 to 35 working days after sample approval, depending on capsule size, coating requirement, and packaging format. We confirm the production window in writing once the purchase order and artwork are finalised.

For delivery, we offer EXW, FOB Shenzhen or Hong Kong, and DDP for select destinations. Air freight is used for samples and urgent orders, with transit times of 3 to 7 days to the US and EU. Sea freight is used for full container loads and takes 25 to 40 days depending on the port. We provide a commercial invoice, packing list, certificate of origin, COA, MSDS, and a free-sale certificate. Where relevant, we arrange phytosanitary certificates for herbal ingredients. We do not ship without a signed specification and approved artwork.

We recommend booking production at least 60 days before your retail launch to allow for sample approval, label review, and freight. For repeat orders, we keep the approved specification and artwork on file, which reduces the lead time by about 5 working days. If you use a third-party logistics provider, we can ship to their warehouse and provide the required ASN data. All shipments are recorded with batch numbers and quantities to support traceability and recall procedures.