HPMC & Gelatin Shells
We work with plant-derived HPMC (Hydroxypropyl Methylcellulose) vegetarian capsules, organic-compliant pullulan, and premium bovine/porcine gelatin shells to meet global dietary preferences.
FDA-Registered Facility · Springville, Utah
Hard Capsule Contract Manufacturing
US-based cGMP encapsulation services for HPMC vegetarian and bovine gelatin hard capsules. Precision filling for powders, botanicals, and complex nutrient blends—delivering market-ready finished goods inside 90 days.
21 CFR Part 111 cGMP Compliant SQF Edition 9 Certified HPMC & Gelatin Shell Sizes 000 to 2
Technical Encapsulation Capabilities
Premier Hard Capsule CDMO Services in the USA
PAG Pharmatech operates advanced high-speed tamping pin encapsulation machinery inside climate-controlled cleanrooms. We provide complete turnkey manufacturing solutions—from formulation optimization and powder blending to capsule filling, primary bottling, and laboratory release testing.
Sizes 000 through 2
Our tooling supports the full industrial size range—Sizes 000, 00E, 00, 0, 1, and 2. Available in crystal-clear, titanium-dioxide-free white, or custom opaque brand color combinations.
High Dosing Accuracy
Automated weight checks and strict statistical process controls prevent fill weight variation, ensuring every individual capsule precisely delivers its active ingredient panel label claims.
Accessible Commercial MOQs
Minimum order quantities start at just 5,000 finished retail units (or 100,000 bulk capsules), allowing emerging DTC brands and Amazon sellers to validate products without overcapitalizing inventory.
Manufacturing Specifications
Hard Capsule Manufacturing Parameter Matrix
Review our operational specifications for custom dietary supplement encapsulation in our Utah plant.
| Capability / Parameter | Manufacturing Specification & Standard |
|---|---|
| Capsule Shell Materials | HPMC (Vegetarian/Vegan), Pullulan (Organic handling), Bovine Gelatin, Porcine Gelatin |
| Standard Shell Sizes | Size 000, Size 00E, Size 00, Size 0, Size 1, Size 2 |
| Fill Materials Handled | Dry powders, standardized botanical extracts, micro-pellets, granulations, hygroscopic active blends |
| Coating & Functional Options | Delayed-release / Enteric capsule shells, band-sealed shells, titanium-dioxide-free color formulations |
| Minimum Order Quantity (MOQ) | 5,000 retail bottles or 100,000 bulk capsules per SKU |
| Primary Packaging Options | HDPE / PET Bottles, Glass Amber Jars, Unit-dose Blister Packs, Flexible Pouches |
| Regulatory Compliance | FDA 21 CFR Part 111 cGMP, 21 CFR Part 117, SQF Edition 9, Halal, Kosher, USDA Organic handling |
| Quality Documentation Issued | Batch Production Record (BPR), Certificate of Analysis (CoA), Master Formulation Record, Allergen Statement |
Integrated Workflow
Our 4-Step Capsule Manufacturing Process
How PAG Pharmatech converts your ingredient concept into a market-ready, compliance-tested hard capsule SKU.
Step 01
Formulation R&D
Our formulation scientists optimize powder bulk density, particle size, flowability, and excipient ratios to guarantee smooth filling and uniform active dosing.
Step 02
Analytical & Stability Testing
We verify raw material identity, screening for microbial contaminants, heavy metals, and pesticide residues while establishing accelerated stability profiles.
Step 03
cGMP Encapsulation
High-speed encapsulation is conducted in humidity-controlled cleanrooms with continuous in-line weight monitoring, visual inspection, and dedusting.
Step 04
QA Release & Shipping
Final analytical testing ensures adherence to USP disintegration and potency specs before issuing a full CoA and dispatching pallets directly to your 3PL.
Buyer Knowledge Base
Hard Capsule Contract Manufacturing FAQs
Essential technical and procurement answers for international sourcing managers and supplement brand owners.
We offer plant-based HPMC (hydroxypropyl methylcellulose) vegetarian capsules, pullulan organic-compliant capsules, and traditional bovine gelatin shells. Sizes range from size 000 down to size 2. Options include clear shells, titanium-dioxide-free white, or custom colors matched to your brand guidelines.
Our standard production MOQ is 5,000 finished retail bottles or 100,000 bulk capsules per SKU. This accessible volume enables growing DTC brands and established companies testing new formulas to maintain lean inventory control.
Every batch is manufactured under 21 CFR Part 111 cGMP and SQF Edition 9 standards in our FDA-registered facility in Springville, Utah. Each delivery includes a finished Certificate of Analysis (CoA) detailing potency assay, heavy metals (Lead, Cadmium, Arsenic, Mercury), microbiology (E. coli, Salmonella, Yeast/Mold), and USP disintegration compliance.
Yes. Our humidity-controlled cleanrooms maintain tight environmental moisture parameters (typically under 40% RH), preventing moisture-sensitive ingredients and herbal extracts from clumping or degrading during blending and encapsulation.
Typical production timelines run 8 to 12 weeks from formula finalization and ingredient validation to final QA release and international shipping.
Ready to Manufacture Your Hard Capsule Formula in the USA?
Connect directly with our Utah-based technical CDMO team. Share your formulation details, shell preferences, and target launch timeline for a detailed contract manufacturing proposal 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 in Springville, UT; certificate copies are available under NDA during formal supplier qualification audits.