Vitamin E Softgel Manufacturer for Global Brands

Vitamin E is oil-soluble and oxidation-prone. We encapsulate it in a sealed softgel shell that limits oxygen contact and masks taste. Our rotary die lines run at 50,000–80,000 softgels per hour, with in-line weight checks every 30 minutes. Shell formulations use gelatin or plant-based alternatives such as starch or carrageenan for vegan and halal claims. We can produce oblong, oval, round, and custom shapes from 5 to 25 minims.

For pilot runs, we offer batches as low as 1,000 units so you can test stability and consumer response before committing to full-scale production. Scale-up to 1,000 units per SKU is straightforward once the formula is locked. Drying tunnels run at 20–25°C and 20–30% relative humidity for 24–48 hours, then we polish and inspect each batch under UV light for defects.

Vitamin E comes in several forms. Natural d-alpha-tocopherol is more bioavailable but oxidises faster; synthetic dl-alpha-tocopheryl acetate is stable and cost-effective. Mixed tocopherols (alpha, beta, gamma, delta) are popular for heart and antioxidant claims. We can blend vitamin E with other oils such as MCT, flaxseed, or fish oil, and add rosemary extract or mixed tocopherols as natural antioxidants. Typical fill weights range from 100 IU to 1,000 IU, with a 200 IU or 400 IU softgel being the most common retail SKUs.

We source vitamin E from EU- and US-approved suppliers with certificates of analysis for each lot. If you need organic certification, we use compliant vitamin E and run the batch on dedicated equipment to avoid cross-contamination. For vegan and halal lines, we use plant-based shells and confirm no animal-derived processing aids. Flavour masking is not needed for softgels, but we can add a light enteric coating if your formula includes sensitive actives.

Every batch is tested for potency, peroxide value, heavy metals, and microbial limits before release. We hold GMP, ISO 22000, and HACCP certifications, and our facility is FDA-registered. Third-party lab testing is available on request. Stability studies run at 25°C/60% RH and 40°C/75% RH for 6–24 months, depending on your market. We provide documentation for EU, UK, US, and Middle East regulatory submissions, including halal certificates where applicable.

Packaging options include HDPE bottles, blister packs, and bulk bags. We ship FOB Shenzhen or Yantian, with air freight for urgent orders. Lead time for mass production is 20–35 working days after sample approval, plus 7–10 working days for samples. For repeat orders, we keep your formula and packaging artwork on file, which reduces reorder lead time by 3–5 days. MOQ for retail bottling is 1,000 units per SKU.

Every vitamin E softgel batch is tested against a written specification before release. Incoming vitamin E oil is assayed for identity and potency by HPLC, with typical acceptance at 95.0–105.0% of label claim for d-alpha-tocopherol and dl-alpha-tocopheryl acetate. Gelatin and glycerol are checked for microbial limits and heavy metals. During encapsulation, fill weight is monitored every 30 minutes with a target tolerance of ±5%, and shell thickness is checked hourly. After drying, finished softgels are sampled for potency, microbials (total aerobic count, yeast and mould, E. coli, Salmonella), heavy metals (lead, arsenic, cadmium, mercury), and disintegration time, typically under 30 minutes in purified water at 37°C.

Batch documentation follows a fixed sequence. A certificate of analysis (COA) is issued per batch and includes the product name, batch number, manufacturing date, expiry date, label claim, test parameters, specification limits, results, and the analyst and QA sign-off. Retention samples of every batch are held for the full shelf life plus 12 months at controlled room temperature. Stability protocols follow ICH Q1A(R2) guidance, with accelerated conditions at 40°C/75% RH for six months and long-term conditions at 25°C/60% RH for up to 36 months. Potency, peroxide value, and disintegration are tested at 0, 3, 6, 9, 12, 18, 24, and 36 months as applicable.

Peroxide value is a key indicator for vitamin E softgels because tocopherols oxidise over time. We set an internal limit of 10 meq/kg at release and monitor it during stability. If a customer requires a tighter limit, we can adjust the antioxidant system or nitrogen-flush the fill. All testing is performed in-house or at accredited third-party laboratories, and raw data is retained for at least five years. For buyers who need batch-specific documentation for regulatory filings, we provide the COA, stability summary, and method summaries in PDF format.

Vitamin E softgels can be packed in HDPE bottles, blister packs, stick packs, or sachets. Common bottle sizes are 60, 90, 120, and 180 count, with induction seals and child-resistant closures where required. Blister packs use PVC/PVDC or alu-alu material for moisture protection. Stick packs and sachets are typically 1–2 softgels per unit for single-dose formats. We can apply your artwork or provide standard label templates. Labelling for the US market follows FDA dietary-supplement requirements: statement of identity, net quantity, supplement facts panel, other ingredients, directions, and allergen declarations where applicable.

Lot and expiry coding are applied by inkjet or laser on the bottle, carton, and shipper. Expiry dating is typically two years from the date of manufacture, supported by stability data. Cartons are specified with dimensions, board grade, and printing to match your retail or e-commerce requirements. Pallet configurations are built to your preferred gross weight and height, usually 1,000–1,200 kg per pallet and up to 1.8 m including pallet. For Amazon sellers, we can print FNSKU labels and apply them to each unit, and we can pack to Amazon's prep requirements, including poly-bagging and suffocation warnings where relevant.

Retail compliance support includes barcode verification (UPC/EAN), nutrition and supplement facts panel review, and country-specific label checks for the EU, UK, Australia, and Canada. We do not provide legal sign-off, but we can flag common issues such as prohibited claims or missing allergen statements before printing. Packaging materials are food-grade and meet EU 10/2011 and US FDA 21 CFR 174–190 requirements where applicable. If you need retail-ready displays, we can source counter displays and shipper displays through our packaging partners.

Sample lead time for vitamin E softgels is 7–10 working days after formulation and artwork approval. Samples are provided free of charge for standard formulations, with freight collect. Mass production runs 20–35 working days after sample approval, depending on fill weight, shell type, and packaging complexity. MOQ is 1,000 units per SKU. For orders above 500,000 softgels, we can schedule dedicated line time and reduce the production window to 18–25 working days, subject to raw material availability.

Shipping is arranged by air or sea. Air freight typically takes 5–8 days door to door for 100–500 kg, while sea freight takes 25–35 days port to port. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for most destinations. DDP includes customs clearance and duties, which simplifies delivery for new importers. For sea shipments, we provide a packing list, commercial invoice, and bill of lading. For air shipments, we provide the air waybill and packing list. All shipments include a COA, material safety data sheet (MSDS), and a free-sale certificate where required by the destination country.

Export documents are prepared in English and can be legalised or apostilled on request. A phytosanitary certificate is not normally required for softgels, but we can provide one for gelatine of animal origin if the importing country asks. We also provide a certificate of origin (Form A, Form E, or general CO) to support preferential tariff treatment. For repeat orders, we keep master batch records and packaging artwork on file, so reorders can be processed without re-submitting documents. Lead times are confirmed in the proforma invoice and are counted from the date of deposit receipt and artwork approval.