Contract capsule manufacturing is a turnkey partnership where a cGMP‑certified facility like Highland Laboratories formulates, encapsulates, tests, packages, and ships finished hard‑shell capsules under your brand name.

We pair 50 years of nutraceutical experience with an on‑site laboratory, high‑speed encapsulators, and FDA registration —giving you faster decision‑making, transparent data access, and “Made in USA” credibility.

Yes. Our FDA establishment registration number and UL certificate are provided in every Quality Agreement and available for on‑site audits.

Tablets, powders, liquids, creams, lotions—ideal when your brand roadmap spans multiple dosage forms.

Yes—over 80 evidence‑backed, market‑tested stock formulas with MOQs starting at very low quantities. 

All industry sizes — 5, 4, 3, 2, 1, 0, 00, 000 — including elongated 00 EL for extra fill weight.

This varies depending on material density, but usually up to ~1,100 mg in size 000, depending on bulk density and flow characteristics.

Bovine or fish gelatin, plant‑based HPMC, and certified‑organic pullulan.

Absolutely—HPMC DR‑Caps® and post‑fill enteric coating protect sensitive actives through gastric transit.

Yes—Pantone® color matching, two-color axial or radial printing, and laser etching are available (minimums vary by color).

Our experienced formulation team optimizes particle size, flow, hygroscopicity, and excipient ratios to hit label claims and machine fill weights.

Yes—beadlet‑in‑oil and liquid‑in‑hard‑shell technologies are ideal for fish oil–plus–vitamin D or other oil‑soluble actives.

We work with 350+ audited suppliers on five continents and provide full country‑of‑origin traceability.

Identity, potency, microbiological, and heavy‑metal testing in our state of the art lab, plus optional third‑party confirmation.

Yes—dedicated allergen‑control protocols and vegan HPMC shells keep cross‑contact below detectable limits.

Industry‑standard is **100,000 – 300,000 pieces** (≈ 1,500 – 5,000 bottles at 60‑ct).

As low as **6 bottles** per SKU.

Custom formulas:  6  –  8 weeks after raw‑material approval. Stock formulas: 2 – 4 weeks.
Raw Material Approval: This can take 6 - 8 weeks to procure and test raw materials. 

Active‑ingredient cost per kg, capsule size and shell type, testing scope, packaging components, and run size.

Yes—50,000‑cap pilot runs are available to validate flow and capsule performance before full‑scale production.

UL‑cGMP, USDA Organic Certified, Non‑GMO Project, Gluten‑Free, plus optional Kosher and Halal certification.

A Quality Management System aligned to 21 CFR 111 & 117, daily deviation reviews, and quarterly internal audits.

Yes—annual FDA, UL, and customer audits; full reports are available under NDA.

Certificate of Analysis, finished‑product specs, MSDS, allergen and gluten statements, flow diagram, and packaging reconciliation.

Absolutely—dedicated audit room, document portal, and pre‑audit gap assessments are included.

They’re plant‑based shells made from hydroxypropyl methylcellulose—non‑GMO, vegan, and more humidity‑tolerant than gelatin.

For vegan markets, hygroscopic ingredients, or supply chains > 65 % RH; HPMC tolerates wider humidity and temperature ranges than gelatin.

Yes—HPMC DR or enteric‑coated shells validated for < 1 % breakage in simulated gastric fluid.

No— we currently do not have this capability for dual‑phase delivery systems separate incompatible actives or stage nutrient release.

Organic pullulan shells and organic excipient systems allow USDA NOP‑compliant SKUs.

HDPE/PET bottles, glass, and eco‑ready pouches.

Yes—FBA & SIOC compliance, scannable barcodes, carton labels, and help navigating certification charge‑backs.

No. 

Integrated pick‑and‑pack with real‑time inventory API lets you ship DTC, B2B, or marketplace orders without leaving our campus.

Climate‑controlled warehousing at 20 – 25 °C and ≤ 60 % RH. Gelatin capsules stored below 77 °F; HPMC tolerates up to 86 °F.

FSC‑certified cartons, recyclable PET, carbon‑neutral energy offsets, and supplier vetting against modern‑slavery indices.

On request, we specify grass‑fed, hormone‑free bovine gelatin with full traceability.

Yes—verified free of animal derivatives and eligible for Kosher & Halal certification.

PLA bio‑resin bottles and compostable pouches are available at higher MOQs.

Closed‑loop capture of dust fines, solvent‑free cleaning, and a campus‑wide recycling rate > 90 %.

21 CFR 111 (cGMP), 101 (labelling), 117 (food safety), plus FTC advertising guidelines.

Yes—our regulatory team drafts FDA‑compliant labels and Amazon/DSHEA disclaimers.

ICH accelerated (40 °C/75 % RH) and real‑time (25 °C/60 % RH) studies with quarterly data points.

Separate weigh‑rooms, validated cleaning, and ELISA swab verification (< 5 ppm).

Yes, please contact for more information. 

Email sales@highland-labs.com or call +1 (503) 300-5400

Target formula, capsule size, annual volume, preferred packaging, and launch date.

Yes—our in‑house studio delivers retail labels, Amazon A+ content, and lifestyle renders.

Our capacity exceeds one billion capsules per year with incremental batch‑size options.

You’ll have a dedicated account manager plus an R&D scientist for technical questions.

About 10 minutes at 37 °C under fasting conditions.

Yes—appropriate certificates are provided with each lot.

Delayed‑release shells are inherently acid‑resistant; enteric coating adds a protective polymer layer after encapsulation.

We offer TiO₂‑free shells that comply with EU 2022/63.

Bulk tamping density (g/cc) × shell volume (cc) = theoretical fill weight.

Relative humidity below 30 %; we humidify rooms and use foil liners to prevent moisture loss.

Yes—in-state‑compliant SKUs with cannabinoid potency and contaminant testing.

Upon request, we include real‑time temp/RH data loggers in export pallets.

All standard excipients are USP grade and tested < 5 ppm gluten.

24 months when validated with delayed‑release shells and silica‑gel desiccant packs.