Gelatin-Free Softgel Manufacturer for Vegan and Halal Brands

Gelatin-free softgels need tighter control of shell moisture and drying. Our rotary die encapsulation lines run modified starch and carrageenan shells at 150–1,200 mg fill weights, with output of 80,000–120,000 softgels per shift. We keep gelatin and non-gelatin campaigns on separate equipment trains to avoid cross-contact. That matters for halal and vegan claims, where trace gelatin is a recall risk rather than a labelling detail.

For pilot runs, we can start at 1,000 units per SKU so you can test stability and consumer response before committing to a full batch. Scale-up to 5,000–50,000 units follows the same formulation, so no re-validation is needed. Tooling for standard oval and oblong shapes is already on site; custom shapes add 10–15 working days to the sample stage.

The shell system determines what you can put inside. Carrageenan and modified starch handle medium-chain triglycerides, fish oil, algal oil, vitamin D3 and CoQ10 well. HPMC is more forgiving with hygroscopic actives and some herbal extracts, but it dries more slowly, which affects cycle time. We test fill-shell compatibility on a 500-softgel pilot batch before any scale-up, checking for shell softening, leakage and fill migration over 4 weeks at 40°C/75% RH.

For halal projects, we source shell ingredients from suppliers with current certificates and keep batch traceability from raw material to finished bottle. Vegan claims require no animal-derived processing aids, so we document the full bill of materials. If your formula needs an enteric or delayed-release profile, we can discuss coating options, though these add cost and lead time.

The facility is GMP-certified and holds ISO 22000 and HACCP. We are FDA-registered for dietary supplement manufacturing, which supports US market entry. Halal and vegan certifications are available per project, subject to ingredient sourcing and audit timing. Every batch ships with a certificate of analysis covering fill weight, shell integrity, microbial limits and heavy metals.

Finished goods leave Guangdong by air or sea. Typical air freight to the US or EU is 5–8 days; sea freight is 18–30 days depending on port. We bottle in 30, 60, 90 and 120 count HDPE or glass, with child-resistant closures where required. Cartons and labels can be printed to your artwork, and we handle lot coding and expiry dating before dispatch.

Every gelatin-free softgel batch is tested against a written specification before release. Incoming raw materials are checked for identity by FTIR and for potency where applicable, with microbial limits and heavy metals (lead, cadmium, arsenic, mercury) screened against USP <232>/<2232> or the destination market's limits. Shell components such as modified starch, carrageenan and HPMC are tested for viscosity, moisture and microbial load, because plant-based shells are more sensitive to water content than gelatin.

In-process checks cover fill weight (target ±5%), seam integrity and shell thickness at start-up, middle and end of each shift. Finished softgels are tested for appearance, disintegration (USP <701>; typically 15–30 minutes for plant shells depending on the system), microbials (TPC, yeast and mould, E. coli, Salmonella), and potency or marker-compound assay. Results are recorded on a batch record that links each lot of shell and fill material to the finished lot number.

A certificate of analysis (COA) is issued per batch and includes the product name, lot number, manufacture and expiry dates, specification and test results with methods, plus a statement of conformity. Retention samples of every batch are kept for at least two years beyond expiry under controlled temperature and humidity. Stability protocols follow ICH Q1A(R2) conditions (25°C/60% RH and 40°C/75% RH) with testing at 0, 3, 6, 9, 12, 18 and 24 months, and accelerated data can be provided for initial shelf-life assignment.

For gelatin-free softgels, we also monitor shell brittleness and fill leakage during stability, since plant shells can lose elasticity faster than gelatin under low humidity. If a batch falls outside specification, it is quarantined and an investigation is opened before any disposition decision. Batch records, COAs and stability summaries are available for customer review and for regulatory filings such as FDA notification or health-supplement registration in the destination country.

Gelatin-free softgels can be packed in HDPE bottles (typically 30, 60, 90 or 120 count), blister packs, stick packs or sachets. Bottles use induction-sealed liners and child-resistant or standard closures depending on market requirements. For Amazon and retail, we can apply FNSKU labels, poly-bag the bottle and print the carton markings to your specification. Blister and stick formats are quoted separately because they change the primary packaging line and lead time.

Labels must carry the elements required by 21 CFR 101.36 for US dietary supplements: statement of identity, net quantity of contents, supplement facts panel with serving size and percent daily value, ingredient list, and the name and place of business of the manufacturer, packer or distributor. We print lot number and expiry date by inkjet or laser on the bottle, carton and, where required, the label itself. Expiry is assigned from stability data, not from a fixed default.

Cartons are specified with dimensions, board grade and print method. A typical 60-count bottle carton uses 300–350 gsm board, and master cartons are sized to a standard pallet footprint (1,200 x 1,000 mm or 1,200 x 800 mm). Pallet configuration, stretch-wrap and edge-board requirements are confirmed before production. We can supply dielines and artwork templates, and we check your artwork against the approved label text before printing.

For retail readiness, we verify barcode scannability (UPC/EAN or FNSKU), country-of-origin marking, and any market-specific statements such as allergen or vegan claims. We do not apply a certification logo unless the relevant certificate is in place for that batch. Packaging components are inspected on receipt for print defects, dimensions and seal integrity, and line clearance is documented between SKUs to prevent mix-ups.

The sample timeline starts with a formulation and shell review, typically 3–5 working days, followed by sample production and dispatch within 7–10 working days of approved specifications. Samples are sent with a draft COA and a specification sheet. If you need a pilot batch before mass production, we quote a pilot quantity below the standard MOQ, usually 1,000–1,000 units depending on fill weight and shell type.

Mass production runs 20–35 working days after sample approval and receipt of packaging components. The window depends on shell type, fill weight, capsule size and whether packaging is bottle, blister or sachet. We confirm a production slot in writing and provide a weekly status update. Delays caused by artwork changes or late packaging components are logged and communicated with a revised ship date.

Shipping is by air or sea. Air freight from Guangdong to the US or EU typically takes 5–8 days door-to-door for small orders; sea freight takes 25–40 days depending on port and service. We quote EXW, FOB (Shenzhen or Hong Kong) and DDP where the destination allows. DDP quotes include duties and clearance but exclude any destination taxes that the buyer is legally required to pay.

Documents provided with each shipment include the commercial invoice, packing list, COA per batch, MSDS where applicable, and a free-sale certificate. For plant-derived materials, a phytosanitary certificate is provided only where the destination authority requires it; it is not issued for every softgel shipment. We can also provide a certificate of origin and, on request, a statement of no genetically modified material and a vegan statement for the shell system.