Bespoke softgel manufacturing

Private label softgels in gelatine or plant-based shells

Round, oval or oblong, clear or coloured, in gelatine or plant-based shells: we develop and make private label softgels for premium wellness brands at our Leicester facility, which is ISO 9001, HACCP and GMP certified by BSI, with oil, suspension or paste fills and actives dosed from micrograms to grams. We concentrate fills to keep softgels small and control oxidation and crosslinking from the formula onwards. Every batch ships with its certificate of analysis. Softgels sit alongside the other supplement formats we manufacture, and your formula is yours.

Softgels are the natural carrier for oils: omega-3, vitamin D in oil, coenzyme Q10 and carotenoids, where a sealed shell keeps out air and hides taste. Nutrition Business Journal data put softgels at 12.5% of US supplement sales in 2025 (Nutraceuticals World, March 2026).

Shells

Fills and dose ranges

Softgel sizes are numbered in minims, about 0.06 ml each, and the fill sets the size. Fills fall into three groups:

• Oil solutions: omega-3 oils, vitamins A, D, E and K in a carrier oil, and seed oils.
• Suspensions: coenzyme Q10, lutein or multivitamin blends as fine particles held in oil by a suspending agent.
• Pastes and combinations: phospholipids, botanical extracts in oil, and combination fills such as omega-3 with vitamin D.

Dose ranges run from micrograms to grams. Vitamin D3 needs only micrograms, so it is diluted in oil to fill a small softgel evenly. Omega-3 runs the other way: the authorised heart claim states that the effect comes with 250 mg of EPA and DHA a day, so concentrates raise EPA and DHA per softgel and cut the number and size of softgels a customer takes. Clinical studies of coenzyme Q10 commonly use 200 to 300 mg a day (Mantle and Dybring, 2020), which suits one to three softgels. Our omega-3 supplement manufacturing page covers the oils in depth.

Omega-3, coenzyme Q10, carotenoids and other oil fills

Gram-dose powders such as creatine, protein and electrolytes suit a sachet or stick pack, and dry botanicals and minerals suit our capsule and tablet manufacturing.

Shell hardness, fill design and crosslinking in a softgel

The shell: gelatine, plasticiser and water

A softgel shell is gelatine, a plasticiser and water. The plasticiser, usually glycerol or sorbitol, keeps the dried shell flexible, and its ratio to gelatine sets the hardness: too little gives brittle shells and leaking capsules, and too much gives soft shells that stick together. The choice follows the fill, because glycerol can migrate into hydrophilic fills, while sorbitol blends hold their place. Gelatine forms films readily, dissolves quickly and gives an effective barrier to oxygen and light, and it remains the primary softgel shell material (Hidayat and colleagues, 2026).

Plant-based shells

Plant-based shells replace gelatine with modified starch and carrageenan. Hydroxypropylated starch brings solubility, heat resistance and water retention, and iota-carrageenan forms elastic gels with calcium that strengthen the film (Hidayat and colleagues, 2026). These shells seal and dry differently from gelatine, so we qualify shell, fill, size and shape together and confirm rupture and leak performance through stability. They also widen a range's reach: porcine gelatine is neither halal nor kosher, and many Hindu consumers avoid bovine gelatine.

Fill design

The fill must live with the shell. Water dissolves gelatine, so fills are oils, oil suspensions or other non-aqueous liquids with only traces of water, and strongly acidic or alkaline fills stay out because they attack the shell. Suspensions need fine, evenly sized particles that pass the fill pump and leave the seal clean, and a suspending agent stops them settling. Crystalline actives need more work: coenzyme Q10 is absorbed only as individual molecules, and its crystalline forms are not absorbed (Mantle and Dybring, 2020), so we dissolve or disperse it in a carrier oil at the fill stage and check that it stays that way through shelf life.

Keeping omega-3 and ubiquinol from oxidising

Omega-3 oils, vitamin A, carotenoids and ubiquinol react with oxygen, and heat, light and trace metals speed the reaction. Ubiquinol, the reduced form of coenzyme Q10, oxidises to ubiquinone by its nature (Mantle and Dybring, 2020). Oils are held cool under nitrogen, antioxidants such as mixed tocopherols or rosemary extract go into the fill, and opaque or coloured shells protect light-sensitive fills. We measure oxidation as peroxide value, anisidine value and TOTOX, against the GOED Voluntary Monograph maximums of 5, 20 and 26 for refined EPA and DHA oils (GOED, 2026).

Crosslinking and its control

Crosslinking is the ageing risk specific to gelatine shells. Trace aldehydes in an excipient or active, high temperature and humidity, or strong light link gelatine chains together, and once started, the reaction continues after the cause is gone. The shell can then form a pellicle, a thin, water-insoluble membrane that holds the fill back in a dissolution test (Lu and Shah, 2017). We control it at every stage. Excipients and flavours are specified for low aldehyde and peroxide content, oils for low anisidine values, since that test measures the aldehydes oxidation forms, and finished softgels are stored and shipped cool and dry. Rupture testing at release and through stability shows any drift early. Where crosslinking makes a gelatine capsule fail a rupture or dissolution test, USP methods allow a retest with enzymes such as pepsin or pancreatin in the medium, which digest the crosslinked layer.

Taste and size

Size and aftertaste decide whether customers keep taking a softgel. Concentrated fills shrink the shell, shape and size are chosen for comfort as well as for the fill, enteric coatings keep an omega-3 softgel closed until it leaves the stomach, and lemon or orange flavours mask fish notes. Flavours are screened in stability, because some carry aldehydes that can crosslink gelatine. For customers who avoid pills, we pair a softgel range with a second format, such as a gummy or a powder.

The rotary die process, from shell mass to dried softgel

We make softgels in Leicester. Our HACCP study for each product type, reviewed annually, sets the critical control points, and every step below is recorded in the batch record.

1. Approve and receive. Gelatine arrives with its animal source documented, and with its halal or kosher certificate where the range needs one. Oils arrive with certificates of analysis for EPA and DHA, oxidation and contaminants. Every supplier is approved before first use and reviewed each year.
2. Prepare the shell mass. Gelatine, plasticiser, water and any colours are melted together under vacuum to remove air, then held at temperature until encapsulation.
3. Prepare the fill. Oils are blended with antioxidants under nitrogen, suspensions are milled, mixed and de-aerated, and coenzyme Q10 is dissolved or dispersed. Uniformity is checked before encapsulation.
4. Encapsulate. The shell mass is cast into two ribbons that meet between two rotating dies. A metering pump injects the fill through a heated wedge between the ribbons, and the dies form, fill and seal each softgel in one step. This is the rotary die process, and fill weight and seal thickness are checked throughout the run.
5. Dry. Softgels are tumble-dried, then dried at controlled temperature and low humidity until the shell reaches its target hardness and moisture.
6. Inspect and polish. Leakers, misshapes and softgels with air bubbles are removed, and the rest are cleaned and polished.
7. Pack and label. Softgels are counted into bottles or sealed into blisters, with nitrogen flushing for oxygen-sensitive fills. Label verification on every batch is our critical control point, CCP-01.
8. Retain and release. We keep three retained samples per batch for shelf life plus one year, and quality control releases every batch against its specification.

A full mock recall, forward and backward with mass balance, runs in seconds.

Rupture, oxidation and leak tests on softgels

Every batch is tested by accredited partner laboratories (ISO/IEC 17025), and batch testing is part of every order. Nothing is dispatched without quality control sign-off. Our testing and batch release page explains each method, and our stability and shelf life testing page explains how shelf life is set.

Our credentials: ISO 9001, HACCP and GMP certified by BSI, and FDA registered. BRCGS implementation under way, certification expected in early 2027.

Packs that hold moisture steady, and shells that set the look

Softgels respond to humidity. In damp air the shell softens and softgels stick together, and over-dried gelatine turns brittle. Packs therefore hold moisture steady rather than strip it out:

• Bottles: HDPE or amber PET with induction seals, nitrogen-flushed for omega-3 and ubiquinol.
• Blisters: high-barrier films that protect each softgel from oxygen and moisture.
• Desiccants: only where stability data show they help, because over-drying makes gelatine shells brittle.
• Storage advice: cool and dry, matched on the label to the stability data.

Presentation starts with the shell. Clear shells show a golden oil, coloured and opaque shells protect light-sensitive fills and give a range its identity, and shapes run from small rounds for vitamin D to oblongs for omega-3. Opaque shells for the EU use colours other than titanium dioxide, which the EU no longer permits in food.

EPA and DHA claims, shell allergens and certification

As of October 2026, these rules shape a softgel label. We design every formula to the rules of the markets you sell in, and our regulation watch tracks the changes.

• UK and EU: softgels are food supplements, labelled "food supplement" with the daily portion and the standard warnings. The shell is an ingredient, so a fish gelatine shell brings fish allergen labelling.
• Claims: "EPA and DHA contribute to the normal function of the heart" needs a source of EPA and DHA and a statement that the effect comes with 250 mg a day, and "Vitamin D contributes to the maintenance of normal bones" needs a source of vitamin D. Coenzyme Q10 has no authorised claim.
• Certification: "vegan" has no legal definition in the UK or the EU, so vegan, halal and kosher certification is arranged for your product, with a matching shell.
• United States: a softgel is a dietary supplement, with a Supplement Facts panel, the shell listed under other ingredients, and structure/function statements carrying FDA's disclaimer.

We are an FDA registered food facility for dietary supplements, and we prepare the specifications for identity, purity, strength and composition that US dietary supplement rules expect. Research and development is a paid stage that can be included with an order of the right size. When your softgel is ready to brief, Start your project.

References: Hidayat and colleagues, Jurnal Pengolahan Hasil Perikanan Indonesia (2026); Lu and Shah, Dissolution Technologies (2017); Mantle and Dybring, Antioxidants (2020); USP general chapter 2040, Disintegration and Dissolution of Dietary Supplements (2015); GOED Voluntary Monograph (2026); ICH Q1A(R2), Stability testing of new drug substances and products (2003); Regulation (EU) No 432/2012 on permitted health claims (2012); Regulation (EU) No 1169/2011 on food information to consumers (2011).