Vegetarian Softgel Manufacturer for Plant-Based Supplement Brands

EUPHM operates two vegetarian softgel lines with a combined capacity of 1.2 million capsules per day. We run pectin-based shells on a rotary die process, which suits oil-soluble actives such as omega-3, vitamin D3, CoQ10 and curcumin. Modified starch shells are used for heat-sensitive ingredients and for fills that require a lower moisture environment. Both lines handle round, oval and oblong formats.

Changeover between shell types takes 4-6 hours. That matters if you plan to run several SKUs in one production window. Tooling is available for 20 standard sizes. Custom tooling for a new shape takes 15-20 working days and carries a one-time cost. We can also run small pilot batches of 1,000 units for stability and sensory testing before you commit to a retail order.

Pectin shells work best with oil-based fills. The shell is hydrophilic, so it resists oxidation of the fill and has a clean release in the stomach. Typical fill weights are 300 mg to 1,000 mg. For vitamin D3, we recommend a 500 mg fill with 2,000 IU per softgel. For omega-3, a 1,000 mg fill with 180 mg EPA and 120 mg DHA is common. Starch shells suit botanical extracts and probiotics where moisture control is critical.

We test every formulation for shell-fill compatibility. That includes a 4-week accelerated stability check at 40°C and 75% relative humidity. If the shell softens or the fill separates, we adjust the plasticiser ratio or switch to a carrageenan blend. Vegetarian softgels typically have a 24-month shelf life. We provide a full stability report with each pilot batch so you can file it with your regulatory consultant.

EUPHM holds GMP, ISO 22000 and HACCP certifications. The plant is FDA-registered. We also carry halal and vegan certifications for vegetarian softgel production. Every batch is tested for microbial limits, heavy metals, and identity of the active ingredient. Certificates of analysis are issued before shipment. We do not claim FDA approval; the facility is registered, which is the correct status for a contract manufacturer.

Shipping terms are FOB Shenzhen or Hong Kong. Air freight to the US or EU takes 5-8 days; sea freight takes 22-30 days. We handle export documentation, including certificate of origin and health certificates. For first orders, we recommend a 30% deposit and 70% against the bill of lading. Lead time for mass production is 20-35 working days after you approve the sample and the artwork.

Every vegetarian softgel batch is tested against a written specification before release. Incoming raw materials, including pectin, modified starch and the active ingredient, are sampled for identity by FTIR and for potency by HPLC or UV methods where applicable. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella. Heavy metals are screened by ICP-MS against USP <232> limits, and disintegration is checked in purified water at 37°C to confirm the shell breaks down within the target window for plant-based shells.

In-process checks run at defined intervals during encapsulation. Fill weight is verified every 30 minutes with a tolerance of ±5%, and seam integrity is inspected visually and by leak testing. At the end of the run, a finished-product sample is pulled for full release testing. A certificate of analysis (COA) is issued per batch and includes the batch number, manufacturing date, expiry date, test parameters, specification limits, results and the analyst and QA sign-off. COAs are available in PDF and can be matched to your SKU code.

Retention samples of each batch are stored for the shelf life plus 12 months under labelled conditions. Stability protocols follow ICH Q1A(R2) where the customer requires it, with accelerated conditions at 40°C/75% RH for six months and long-term conditions at 25°C/60% RH or 30°C/65% RH. Real-time data is collected at 0, 3, 6, 12, 18 and 24 months. For pectin shells, moisture pick-up and shell hardness are monitored alongside potency and microbial counts, because plant-based shells are more sensitive to humidity than gelatin.

If a batch fails any specification, it is placed on hold and an investigation is opened. Root cause is documented, and corrective action is agreed with the customer before any rework or re-test. Deviation reports and out-of-specification records are retained for at least five years and can be shared during customer audits. We do not release a batch on a verbal waiver.

Vegetarian softgels can be packed in HDPE bottles, PET bottles, blister packs, stick packs or sachets. Bottle sizes commonly run from 30 to 180 counts, with induction seals and child-resistant or standard caps. Blister options include PVC/PVDC and aluminium-aluminium for moisture-sensitive fills. Stick packs and sachets are filled at 1 to 5 g per unit and are suited to single-dose formats. We can supply desiccant canisters or silica gel sachets where the shell requires low humidity.

For the US market, labels must carry the statement of identity, net quantity of contents, supplement facts panel, ingredient list, allergen declaration and the manufacturer or distributor address. We check that the label includes a lot code and a best-by or expiry date in the agreed format. For the EU, we reference the Food Supplements Directive and the relevant national rules, and we flag claims that need substantiation. We do not write claims for you, but we review label artwork against the approved formula before printing.

Lot coding is applied by inkjet or laser on the bottle, carton and shipper. Expiry dating follows the stability data for the specific formula and shell type, typically 24 months for pectin-based softgels when stored below 25°C and 60% RH. Cartons are specified with gross weight, dimensions and case pack count. Standard pallet footprints are 1,200 x 1,000 mm and 1,200 x 800 mm, with stretch wrapping and edge protectors. We can print Amazon FNSKU labels and apply them to poly-bagged units if required.

Retail readiness checks cover barcode verification (UPC or EAN), Nutrition Facts or Supplement Facts alignment, and artwork sign-off. For Amazon sellers, we can pack in poly bags with a suffocation warning and apply the FNSKU over the original barcode. We do not guarantee marketplace approval, but we provide the label files and packing configuration needed for your compliance review.

Sample production starts after formula and shell agreement. Standard sample lead time is 7 to 10 working days for a 1,000-unit pilot run, excluding shipping. If a new shell blend or a custom colour is required, add 5 to 7 working days for bench trials. Samples are sent with a preliminary COA and a packing list. Sample costs are quoted per project and are not credited against mass production unless agreed in writing.

Mass production runs 20 to 35 working days after sample approval and receipt of the deposit. This window covers raw material release, encapsulation, drying, testing and packing. Delays occur when artwork is not approved or when a raw material is on backorder; we notify you within two working days of any schedule change. For repeat orders with the same formula and packaging, the window is typically 20 to 25 working days.

We quote EXW, FOB Shenzhen or Hong Kong, and DDP for most destination countries. Air freight is used for samples and urgent orders, typically 5 to 8 days door to door. Sea freight is used for full containers and takes 25 to 40 days depending on the port. LCL is available for smaller volumes. We provide a commercial invoice, packing list, bill of lading or airway bill, COA, MSDS where relevant, and a free-sale certificate on request. Phytosanitary certificates are not normally required for softgels but can be arranged if your import authority asks for one.

For DDP shipments, we handle customs clearance and duty payment and provide the entry documents after delivery. We recommend confirming the Incoterm and the named place in the proforma invoice before production starts. Storage at origin is free for 14 days after production; after that, a weekly storage fee applies.