US-Based Supplement Manufacturing  ·  FDA-Registered & GMP Certified  ·  8–12 Week Lead Times
FDA Registered SQF Ed. 9 Halal & Kosher 30 Years CDMO
FDA-Registered Facility · Springville, Utah

Softgel Supplement Contract Manufacturing

Precision oil encapsulation, custom liquid fill formulas, targeted enteric coating, and plant-based vegetarian options — engineered under 21 CFR Part 111 cGMP standards for international supplement brands and distributors.

FDA-Registered Encapsulation SQF Ed. 9 & cGMP Certified Nitrogen-Blanketed Fill System Global Customs & Export Compliance Halal, Kosher & Non-GMO
High-Bioavailability CDMO Capability

Advanced softgel encapsulation designed for optimal lipophilic stability

PAG Pharmatech America delivers pharmaceutical-grade softgel manufacturing for global brand owners, importers, and marketplace sellers. Our Utah facility combines state-of-the-art rotary die encapsulation with continuous nitrogen purging to guarantee zero lipid oxidation and maximum potency throughout shelf life.

Protected Lipid Active Fill

Complete nitrogen-blanketed mixing and encapsulation environment prevents oxygen exposure, protecting sensitive Omega-3 marine oils, CoQ10, and botanical extracts against rancidity and degradation.

Targeted Enteric Delivery

Custom aqueous enteric film coating bypasses stomach acidity, releasing sensitive active compounds directly in the upper intestine. Eliminates fishy repeat, odor, and stomach discomfort for end consumers.

Flexible Shell Selection

Choose from 100% pure Pharmaceutical Bovine Gelatin, Porcine Gelatin, Kosher/Halal Fish Gelatin, or cutting-edge non-GMO Tapioca Plant Starch for pure vegetarian and vegan market positioning.

Technical Specifications

Softgel engineering matrices & parameters

Our internal quality systems ensure tight fill weight tolerances (±1.5%), seamless seam fusion, and standardized disintegration compliance for international registration requirements.

Shell & Encapsulation Options

Shell MaterialsBovine Gelatin, Fish Gelatin, Vegetarian Tapioca
Available ShapesOval, Oblong, Round, Tube, Dropper
Coloring CapabilitiesOpaque, Clear, Two-Tone, Natural Clean-Label Pigments
Custom ImprintingFood-grade logo, strength, or brand lettering
Specialty CoatingsEnteric, Delayed-Release, Chews/Chewable Softgel

Formulations & Fill Matrix

Marine OilsHigh EPA/DHA Fish Oil, Krill Oil, Algal DHA
Fat-Soluble ActivesVitamin D3, Vitamin K2 (MK-7), Vitamin E, CoQ10
Botanical LipidsSaw Palmetto, Evening Primrose, MCT, Curcumin Oil
Suspensions & PastesMicro-milled particulate oil suspensions
Minimum Order QuantityFrom 5,000 retail bottles / 100,000 bulk softgels
Strict Quality Governance

Certified c-GMP manufacturing & export documentation

Every batch produced at our Springville, Utah facility undergoes rigorous analytical batch release testing. We provide full compliance documentation to support smooth customs clearance for overseas buyers in North America, Europe, Asia, and the Middle East.

Full Certificate of Analysis

Every shipment is accompanied by a detailed Certificate of Analysis (CoA) from ISO 17025 accredited third-party laboratories detailing active ingredient assay, heavy metals (ICP-MS), microbiology, and peroxide/anisidine oxidation values.

Peroxide & Anisidine Monitoring

To ensure freshness and eliminate rancid tastes in fish oils and lipid blends, we maintain strict total oxidation (TOTOX) testing protocols on raw ingredients, in-process fill oils, and finished softgel batches.

Global Export Support

We supply complete regulatory dossiers for global distribution, including Certificate of Free Sale (CFS), BSE/TSE-Free Statements, Allergen Declarations, Halal/Kosher certificates, and US FDA Registration documentation.

Structured Production Path

Our turnkey softgel workflow from brief to dispatch

We eliminate technical delay and batch variance through standardized technology transfer protocols and accountable project management.

Step 01

Formula R&D & Sourcing

Selection of high-purity lipid actives, carrier oils, and shell gelatin. Pilot batch stability and viscosity screening under NDA.

Step 02

Nitrogen Compounding

Deaeration and vacuum mixing under nitrogen atmosphere to protect active ingredients from thermal and oxidative stress.

Step 03

Rotary Die Encapsulation

Precision ribbon casting, micro-injection filling, continuous seam sealing, controlled tumble drying, and laser sorting.

Step 04

QA Release & Export

Analytical laboratory batch release, Certificate of Analysis generation, primary/secondary packaging, and worldwide freight handling.

Procurement & Technical Clarifications

Softgel contract manufacturing FAQs

Key answers for commercial procurement managers, technical formulation directors, and international buyers.

Our standard production MOQs start at 5,000 retail-ready bottles for private label programs and emerging DTC brands. For bulk unbottled softgel capsules exported in cartons with moisture-barrier liners, our baseline encapsulation batch size starts at 100,000 softgels per formulation.

We provide pharmaceutical-grade 200-Bloom Bovine Gelatin, Porcine Gelatin, Kosher & Halal certified Fish Gelatin (ideal for pescatarian diets), and 100% vegetarian non-GMO Plant Starch (Tapioca-based). Capsules can be customized in clear, opaque, tinted, or two-tone colors with options for enteric or chewable shell textures.

Our Springville, Utah facility implements closed-system liquid transfer and continuous nitrogen purging across all oil blending tanks, aging tanks, and encapsulation hoppers. This ensures dissolved oxygen remains near zero, suppressing peroxide values (PV) and maintaining low TOTOX scores throughout the product's shelf life.

Yes. We offer aqueous-based, solvent-free enteric coating that enables softgels to remain intact through the acidic environment of the stomach (pH 1.2) and dissolve completely in the alkaline fluid of the small intestine (pH 6.8). This format is widely used to prevent fishy burps, protect acid-sensitive nutrients, and maximize intestinal absorption.

Every manufactured batch is released with a comprehensive regulatory file containing the finished product Certificate of Analysis (CoA) with heavy metal, microbial, and assay data, cGMP Compliance Certificate, Master Batch Record summary, BSE/TSE-Free Statement, Allergen Declaration, and Certificate of Free Sale (CFS).

Ready to manufacture your custom softgel line in the USA?

Consult with our Utah-based formulation specialists for technical feasibility, custom oil matrix quotes, and expedited 8–12 week production schedules.

Send an Inquiry

US-Based Softgel CDMO Excellence

Contact our commercial team today for sample requests, facility audit scheduling, and formula cost estimates. Replies sent within 1 business day.

FDA registration does not constitute FDA approval or endorsement of any product. Certifications are held by our FDA-registered manufacturing operation; certificate copies are available under NDA during supplier qualification.