Vitamin K2 Softgel Manufacturer for MK-7 and MK-4 Formulas

Our softgel lines handle both gelatin and non-gelatin shells, including bovine, porcine, fish and vegan HPMC options. For vitamin K2, the oil blend is prepared in jacketed stainless steel tanks, then filled on rotary die encapsulation machines. We control fill weight to within +/-3% and monitor shell thickness and seam quality throughout the run. Drying, sorting and polishing follow on-site, so the softgels arrive at the packaging stage with consistent appearance and hardness.

Tooling is available in oval, oblong, round and custom shapes. Standard sizes cover 150 mg to 900 mg fill weight, which fits most K2 and K2+D3 daily-dose formats. If your formula needs a smaller or larger softgel, we can quote new tooling. Bottling lines handle 30, 60, 90, 120 and 180 count formats with induction sealing, child-resistant caps and label application. EUPHM also supports bulk softgel supply for brands that fill and label in their own market.

Vitamin K2 is supplied as menaquinone-4 (MK-4) or menaquinone-7 (MK-7). MK-4 has a shorter half-life and is often dosed at 45 mg or higher per softgel. MK-7 is used at lower doses, commonly 45 mcg to 200 mcg, and is frequently paired with vitamin D3. Both forms are oil-soluble, so they disperse well in the softgel fill. We can source MK-7 from chickpea fermentation or natto fermentation, depending on your label and market requirements.

Carrier oils include MCT, olive, sunflower and flaxseed. The choice affects mouthfeel, oxidative stability and label claims. For K2+D3 combinations, we adjust the oil blend so both actives remain in solution and the fill stays clear. Antioxidants such as mixed tocopherols can be added to protect the oil. If you need a specific ratio, such as 100 mcg K2 with 2,000 IU D3, we will match it and confirm the analytical values in the finished softgel.

Every vitamin K2 softgel batch is tested for identity, assay, fill weight, disintegration and microbial limits. We hold GMP, ISO 22000 and HACCP certifications. Depending on your destination market, we can produce under halal or vegan programmes. Documentation includes certificate of analysis, specification sheet, allergen statement and, where required, heavy metals and residual solvent testing. The facility is FDA-registered for dietary supplement manufacturing.

For EU and UK buyers, we prepare product specification files and support label review against local claims rules. For US buyers, we align with FDA labelling and cGMP expectations. For Middle East markets, halal certification and Arabic labelling support are available. Retain samples are kept for the shelf life of the product plus six months. If you already work with a third-party laboratory, we can send samples and documentation directly to them for verification.

Every vitamin K2 softgel batch is tested at three stages: incoming raw material, in-process fill weight and shell integrity, and finished product. Identity and potency of MK-4 or MK-7 are confirmed by HPLC against a reference standard, with typical acceptance at 95.0 to 105.0 percent of label claim. Microbials follow USP <2021> and <2022> limits, heavy metals are screened by ICP-MS to USP <232> and <233>, and disintegration is checked to USP <2040> at 37 degrees Celsius. Tests are run on each lot, not composited across lots.

The certificate of analysis for a vitamin K2 softgel batch lists lot number, fill weight, assay result, microbial results, heavy metal results, disintegration time, appearance, and a statement of compliance. It is issued in PDF and signed by the QC manager. Retention samples of every lot are held for 24 months at 25 degrees Celsius and 60 percent relative humidity, with a second set at 30 degrees Celsius and 65 percent relative humidity for accelerated stability. Stability protocols cover 0, 3, 6, 12, 18 and 24 months for potency, peroxide value and disintegration.

For vitamin K2 softgels, peroxide value and anisidine value are monitored because the oil vehicle can oxidise even when the active is stable. Shell hardness and seam thickness are checked hourly during encapsulation, and fill weight is verified every 30 minutes with a target tolerance of plus or minus 5 percent. Any out-of-specification result triggers a batch hold and a documented investigation before release. We do not release a lot on a verbal approval or a partial COA.

Documentation packs include the batch record, COA, raw material COAs, packaging component specifications and a deviation log if applicable. For private-label vitamin K2 softgel projects, the brand owner receives the finished-product COA before shipment and can request the retention sample set at cost. If a retail customer requires a specific microbial limit, such as a tighter total aerobic count, the specification is written into the master batch record before the first production run.

Vitamin K2 softgels can be packed in HDPE bottles from 30 to 180 count, blister packs of 10 to 30 softgels, stick packs, or single-serve sachets. Bottles use induction seals and child-resistant or standard caps depending on market. Common bottle sizes are 60 cc, 100 cc and 150 cc with 38 mm or 45 mm necks. Blister material is PVC/PVDC or alu-alu for moisture-sensitive formulas. Cartons are specified with board grade, print process and dimensions, and pallets are typically 1,200 by 1,000 mm or 1,200 by 800 mm with a stated case count.

For the US market, the dietary supplement label must carry a Supplement Facts panel with serving size, amount per serving, percent daily value where established, and a list of other ingredients. The principal display panel must show the net quantity of contents. Lot code and expiry date are printed on the bottle, carton and case in a legible format, and we retain the coding record for each run. We do not print structure-function claims without the brand owner's approved wording and a copy of their substantiation file.

Retail readiness includes Amazon FNSKU labelling, poly-bagging where required, and carton markings that match the marketplace's inbound requirements. We can apply FNSKU labels or ship neutral cartons for the brand owner to label at their own facility. For EU retail, we check that the label carries the food business operator address, allergens, and the mandatory nutrition declaration where applicable. Labelling artwork is approved in writing before plates or digital print files are released, and a signed proof is kept with the batch record.

Packaging components are inspected on receipt for dimension, print quality and seal integrity. Bottle fill weight and torque are checked at start-up and every hour. A typical vitamin K2 softgel order ships with bottles in a display carton, cartons in a shipper, and shippers on a pallet with corner boards and stretch wrap. We can provide a packaging specification sheet with bottle dimensions, cap type, label size and carton weight for the brand owner's logistics team.

Sample lead time for a vitamin K2 softgel is 7 to 10 working days after formula and shell specification approval. Samples are sent with a preliminary COA and a packaging mock-up if requested. Mass production runs 20 to 35 working days after sample approval, depending on fill weight, shell type and packaging format. A 1,000 unit retail bottling run is the standard minimum order quantity per SKU, and pilot runs below that are quoted case by case.

Delivery is quoted EXW, FOB or DDP. FOB ports are typically Shenzhen or Hong Kong, and DDP is available for the US, EU, UK, Australia and Canada with duties and taxes handled by the freight forwarder. Air freight is used for samples and urgent replenishment, usually 5 to 8 days door to door. Sea freight is used for full pallets, typically 25 to 40 days depending on destination port. We provide a packing list with carton dimensions, gross weight and pallet count before booking.

Documents provided with each vitamin K2 softgel shipment include the commercial invoice, packing list, bill of lading or airway bill, COA, MSDS where required, and a free-sale certificate for markets that request one. A phytosanitary certificate is not normally relevant for softgels, but we can supply a certificate of origin and, where the destination requires it, a halal certificate for the specific lot. Documents are issued in PDF and legalised or attested only when the destination market requires it.

For repeat vitamin K2 softgel orders, we hold the approved formula, shell specification, artwork and packaging components on file so the next run does not repeat development. Lead time for a repeat order is typically 18 to 25 working days from purchase order and deposit. Payment terms are usually 30 percent deposit with the balance against the bill of lading copy, and we can discuss letter of credit terms for larger programmes. We do not ship without a signed artwork approval and a released COA.