GMP Certified · FDA-Registered · USA-Based
Custom Softgel Manufacturing
Hermetically sealed lipid-based delivery for maximum bioavailability and shelf life.
150,000
Minimum softgel run
per custom SKU
12–16 wks
Typical lead time
deposit to delivery
Hermetic seal
One-piece shell integrity
superior O₂ barrier vs. capsules
Definition
What Is Custom Softgels Manufacturing?
Custom softgel manufacturing is a specialized one-step encapsulation process in which a liquid, suspension, or semi-solid fill material is simultaneously formed and hermetically sealed inside a soft, flexible, one-piece shell — typically made from gelatin or a plant-based (HPMC) polymer. Shell and fill are produced together on a rotary die machine, creating an airtight capsule with superior oxygen barrier properties. All softgel production is conducted under 21 CFR Part 111 cGMP with release testing per USP standards.
Why brands choose softgels
Softgels are the preferred delivery format for oil-based, fat-soluble, and oxygen-sensitive active ingredients. Their hermetically sealed shell provides superior protection against oxidation and moisture compared to two-piece hard-shell capsules, extending shelf life and preserving potency for lipid-sensitive compounds. Consumer compliance is also higher for softgels than tablets — the smooth, easy-to-swallow oval shape consistently ranks as the preferred format in consumer preference studies.
Brand fit
Is softgels the right form for your brand?
$$
Cost to make
Customer compliance
Why brands choose softgels
- ✓Best bioavailability for oil-based actives — the lipid matrix aids absorption in a way dry powder can't
- ✓Easiest solid form to swallow — smooth oval shape reduces resistance vs. tablets or capsules
- ✓Hermetic seal protects oxygen-sensitive ingredients better than any two-piece capsule
- ✓Customers already expect softgels for fish oil, vitamin D, and CoQ10 — category fit is built in
Things to know before you commit
- →20–40% higher per-unit cost than capsules
- →Longer production cycle — each batch requires 24–48 hours of drying time
- →Only makes sense when the formula calls for it — no advantage over capsules for dry powder formulas
Best fit
Oil-based and fat-soluble formulas: omega-3, vitamin D3/K2, CoQ10, astaxanthin, hemp extracts. Any formula where bioavailability is a legitimate differentiator.
May not be the right fit
Water-soluble vitamin and mineral formulas, or any formula where the cost premium isn't justified by an absorption advantage.
Not sure which form is right for your brand?
Compare all four forms side by side →What We Produce
Softgels Types We Manufacture
Every format is produced in our FDA-registered, cGMP-certified facility with full third-party testing and batch documentation.
Bovine Gelatin
Most CommonStandard softgel shell derived from bovine collagen. Widest compatibility with oil-based fills. Most common in the market.
Fish Gelatin
Halal / KosherDerived from fish collagen. Halal and kosher-certifiable. Compatible with omega-3 and marine-derived ingredient fills.
Vegan HPMC
VeganPlant-based softgel shell for vegan D3 (lichen-derived), algae omega-3, and plant-based oil formulas.
Enteric Softgels
SpecialtyAcid-resistant polymer coating applied post-production. Protects acid-sensitive fills like fish oil and probiotics from gastric exposure.
Capabilities
Softgels Manufacturing Specifications
Our facility is built for high-volume commercial production. Every specification below is verified in-process and confirmed by third-party laboratory testing before any lot is released.
Get a Custom Quote →| MOQ | 150,000 softgels per SKU |
| Available sizes | Oval and oblong, 3 to 30 minims fill volume |
| Shell options | Bovine gelatin, fish gelatin, vegan HPMC |
| Fill compatibility | Oils, lipid suspensions, semi-solids, wax matrices |
| Typical lead time | 12–16 weeks from deposit |
| Oxidative stability | Peroxide value and anisidine value testing |
| Regulatory | cGMP 21 CFR Part 111, FDA-registered facility |
How It Works
The Softgels Manufacturing Process
From formula intake to certified finished product. Every step is documented, tested, and traceable — because your brand's reputation depends on it.
Formula Intake & R&D
Submit your target function, active ingredients, and volume goals. Our R&D team reviews your formula for ingredient synergy, regulatory compliance, and cost-per-bottle efficiency before committing to a pilot run.
Raw Material Sourcing & QC
We source every raw material from audited suppliers and verify identity and purity against the certificate of analysis using FTIR spectroscopy before any ingredient enters production.
Pilot Run & Approval
A pilot batch is produced at reduced scale to verify blend uniformity, fill weight accuracy, and finished-product appearance. You review and approve a physical sample before full-scale production begins.
Full-Scale Production
Your formula runs on our dedicated production line with continuous in-process quality controls: hardness/fill weight checks, content uniformity sampling, and environmental monitoring at defined intervals.
Third-Party Testing & Release
Every production lot is sent to an ISO/IEC 17025-accredited third-party laboratory for identity, potency, microbial, and heavy metal testing. We release only when all specifications are confirmed. Your Certificate of Analysis and batch records ship with every order.
What We Formulate
Top Softgels Formulation Categories
The supplement categories below represent the highest-demand and most profitable softgels-format products in the U.S. market. Our R&D team specializes in all of them.
Omegas & Fatty Acids
Fish Oil (EPA/DHA), Krill Oil, Algae DHA, Evening Primrose
Fat-Soluble Vitamins
Vitamin D3/K2, Vitamin E (tocopherol), Vitamin A, Vitamin K
Antioxidants
CoQ10 (ubiquinone/ubiquinol), Astaxanthin, Lutein, Lycopene
Herbal Extracts in Oil
Turmeric (in black pepper oil), Boswellia, Black Seed Oil
Hemp & Botanicals
Hemp extract, CBD oil, Evening Primrose, Flaxseed Oil
Cognitive Support
Phosphatidylserine, DHA, Bacopa extract, Phosphatidylcholine
Quality Assurance
Uncompromising QA on Every Softgels Lot
Every production lot undergoes multi-stage testing by ISO/IEC 17025-accredited third-party laboratories. We provide full Certificates of Analysis and batch records with every order — because your customers and the FDA deserve nothing less.
- ✓Identity & Potency (FTIR + HPLC) — confirms every active matches its COA
- ✓Microbial Screening — Total Plate Count, Yeast, Mold, E. coli, Salmonella, Staphylococcus
- ✓Heavy Metals (ICP-MS) — Lead, Arsenic, Cadmium, Mercury per USP <2232>
- ✓Allergen Segregation — dedicated production areas for major allergens
- ✓In-Process Controls — per-batch weight, hardness, fill accuracy checks
| Capability | Generic Mfg. | Private Label Express |
|---|---|---|
| cGMP 21 CFR Part 111 | ✗ | ✓ |
| FDA-Registered Facility | ✗ | ✓ |
| Third-Party Potency Testing | ✗ | ✓ |
| Heavy Metal Screening (ICP-MS) | ✗ | ✓ |
| Full Batch Records & COA | ✗ | ✓ |
| R&D Formulation Support | ✗ | ✓ |
| In-House Fulfillment Option | ✗ | ✓ |
Robert De Lima
· Founder & CEO, Private Label ExpressWith a background in pharmaceutical manufacturing, Robert founded Private Label Express in 2010 to correct the transparency and reliability issues endemic to the dietary supplement contract manufacturing industry. He oversees formulation standards and quality systems across all production lines.
Fact-checked by Private Label Express Quality Review Board · Updated June 2026
Common Questions
Softgels Manufacturing — FAQ
Questions about our softgels manufacturing process, capabilities, and specifications.
What is the minimum order quantity for custom softgel manufacturing?+
What types of ingredients are best suited for softgel delivery?+
Do you manufacture vegan softgels?+
What is the difference between a softgel and a liquid-filled hard capsule?+
How do you ensure potency stability in softgels?+
What softgel sizes and shapes are available?+
Ready to Scale?
Start Your Custom Softgels Run
If you're an established brand-owner ready to scale your softgels line, our team will review your formula and volume goals and respond within one business day.
Minimum 150,000 units per run · Serious inquiries only · Founded 2010