Softgel Manufacturer for Dietary Supplements

Our softgel line uses rotary die encapsulation with a 24-inch die roll. Line capacity reaches 1.2 million softgels per shift. We run gelatin and non-gelatin shells, including fish gelatin, starch, and carrageenan. Shell drying tunnels control temperature and humidity to 20–25°C and 20–30% RH. That prevents sticking and gives a uniform seam. Inline weight sorting rejects any softgel outside ±3% of target fill weight.

We produce oblong, oval, round, and custom shapes. Enteric coating is available for delayed release. For probiotics and sensitive actives, we use a cold-fill process that keeps the fill matrix below 30°C. Changeover between SKUs takes 4–6 hours, which keeps small runs practical. Every batch is traceable from raw material lot to finished bottle.

Softgels carry oils, pastes, and suspensions. Common fills include fish oil, krill oil, MCT oil, CoQ10, vitamin D3, vitamin E, and carotenoids. We test every incoming oil for peroxide value, free fatty acids, and heavy metals. For suspensions, we mill actives to a D90 under 50 microns to prevent settling. Antioxidants such as mixed tocopherols protect oxidation-sensitive fills.

Shell formulation matters for dietary and religious claims. We offer bovine gelatin, porcine gelatin, fish gelatin, and vegan starch shells. Halal certificates apply to specific shell and fill combinations. Organic certification is available when all ingredients hold organic status. We also produce sugar-free and titanium dioxide-free shells for EU and UK markets.

Our facility is GMP-certified and FDA-registered. We hold ISO 22000 and HACCP certifications. Each batch goes through identity testing, assay, microbial limits, and disintegration testing. We retain samples for 24 months. Certificates of analysis list fill weight, shell weight, and total softgel weight. Third-party lab testing is available on request.

Export documentation covers health certificates, certificates of origin, and halal certificates. We provide stability data at 25°C/60% RH and 40°C/75% RH for 24 months. For US clients, we supply FDA prior notice and facility registration details. For EU clients, we provide compliance statements for novel food and contaminants. Label review support is included at no extra cost.

Every softgel batch is tested against a written specification before release. Incoming raw materials are sampled for identity by FTIR and assay by HPLC or GC. During encapsulation, we monitor shell thickness, seam integrity, and fill weight every 30 minutes; the target fill weight is held to ±5%. After drying, each lot is tested for microbials (total aerobic count, yeast and mould, E. coli, Salmonella), heavy metals (lead, cadmium, arsenic, mercury), and disintegration. Potency testing is performed on the finished softgel, not just the bulk fill, to confirm the label claim survives the encapsulation process.

A Certificate of Analysis (COA) is issued for each batch and includes the product name, lot number, manufacturing date, expiry date, tests performed, specification limits, and results. Where a customer requires it, we include the method reference (e.g., USP <2021> for microbial limits, USP <711> for disintegration). Retention samples of every lot are kept for the full shelf life plus six months, stored under labelled conditions. Stability protocols follow ICH Q1A(R2) guidelines: 25°C/60% RH for long-term and 40°C/75% RH for accelerated, with testing at 0, 3, 6, 9, 12, 18, and 24 months. We provide stability data summaries for your regulatory filings.

For softgel-specific quality, we also check shell integrity after accelerated stability, as gelatin shells can cross-link under high humidity. We monitor bloom strength of the gelatin and, for vegan softgels, the hydroxypropyl methylcellulose (HPMC) grade. If a batch fails any specification, it is placed on hold, investigated, and either reworked or rejected. We do not release product without a signed QA release. Documentation is provided in English; translations can be arranged on request.

We offer primary packaging in HDPE bottles (30, 60, 90, 120, 180, 250 counts), blister packs (PVC/PVDC or alu-alu for moisture-sensitive fills), and single-serve sachets or stick packs. Bottles can be induction-sealed and include a desiccant canister or silica gel sachet. For blisters, we use forming and lidding films that meet USP <671> moisture permeation requirements. We can also pack softgels into bulk drums for repackaging at your facility. Secondary packaging includes retail cartons with your artwork, lot and expiry coding via inkjet or laser, and tamper-evident seals.

For the US market, we structure labels to include the FDA-required dietary supplement facts panel: serving size, amount per serving, % Daily Value where applicable, other ingredients, and the mandatory disclaimer. We also handle allergen statements, storage instructions, and country of origin marking. For EU and UK, labels are prepared according to local nutrition and health claims regulations, and we can include the address of the responsible person. We do not provide legal review of claims; that remains the brand owner's responsibility.

Lot and expiry coding follows your format: Julian date, production date plus shelf life, or a specific expiry date. We maintain a coding record for traceability. Cartons are specified with dimensions, board grade (e.g., 350 gsm), and print method. Palletisation follows standard 1200×1000 mm or 1200×800 mm pallets, with stretch wrapping and edge protectors. For Amazon FBA, we can apply FNSKU labels and poly-bag units if required, and we provide carton weight and dimension data for your shipping plan. Retail compliance for large chains often requires a GS1 barcode on the carton; we can print and verify it.

Sampling starts with a 7–10 working day turnaround from receipt of your formula and shell requirements. We provide up to 500 g of bulk softgels or 100 finished bottles for your evaluation. Pilot runs have a minimum of 1,000 units per SKU and take 15–20 working days, including stability set-up. Mass production runs 20–35 working days after artwork approval and receipt of deposit. These timelines assume raw materials are in stock; specialty oils or actives may add 2–3 weeks. We confirm lead times in writing before order confirmation.

We ship worldwide from Guangdong. For small orders or urgent launches, air freight (3–7 days to US/EU) is available; sea freight (25–40 days depending on port) is more economical for pallet quantities. We work with your nominated forwarder or can arrange door-to-door delivery. Incoterms offered are EXW, FOB (Shenzhen or Hong Kong), and DDP for select destinations. DDP includes customs clearance and duty, but we recommend confirming the landed cost with your broker.

Documentation provided with each shipment includes the commercial invoice, packing list, bill of lading or airway bill, Certificate of Analysis, Material Safety Data Sheet (MSDS) for the finished product, and a free-sale certificate where required. For plant-based ingredients, we can supply phytosanitary certificates if the destination country requires them. Halal certificates are available for the relevant shell and fill combinations. We do not provide certificates of origin unless requested; these can be arranged through the local chamber of commerce.

A softgel is a sealed, single-unit package for liquids: fish and algal omega-3, vitamin D, CoQ10, lutein, CBD-type oils. Because the fill is already liquid, there is no dissolution step to fail, oxidation is limited by the shell, and the dose is tamper-evident. Typical fill volume is 200–1,200 mg, which covers most oil-based actives in one or two pieces.

It cannot hold water. Water-soluble actives have to be milled into a suspension paste with an oil carrier, which limits how high you can dose and can cause settling during the run. Vegetarian softgels (starch or alginate shell) exist but cost more and have a narrower processing window than gelatin, and any softgel with a fish or bovine shell will not carry a vegan claim no matter what the fill is.

The encapsulation machine forms the shell at 55–60 °C and seals it on a rotating die; seam quality is the whole game, so we run a leak test and a visual seam check on a fixed interval and reject the run if the fill weight drifts beyond ±3%. Freshly made softgels go through a drying tunnel for 12–24 hours, then a tumble dry, until the shell loses the right amount of water — over-dry and it cracks in the bottle, under-dry and the pieces stick together.

For oils, the chemistry matters as much as the machine. Peroxide value and anisidine value are checked on incoming oil and again on the finished fill, because a softgel that has already oxidised will fail taste and shelf-life complaints long before it fails an assay. Enteric coating, if you need it, is a second pass with its own adhesion and disintegration checks.