OEM · ODM · Contract Manufacturing

Manufacturing Services Built Around Your Red Yeast Rice Vision

From precision fermentation to finished capsules, Twin Horse provides integrated OEM and ODM services for brands that refuse to compromise on quality, traceability, or science.

Our Capabilities

Six integrated services, one accountable partner

Every engagement is led by a dedicated project manager and supported by in-house microbiologists, formulation chemists, and regulatory specialists. You brief the vision — we handle cell to capsule.

OEM Manufacturing

Full-scale production of red yeast rice extract capsules, tablets, and powders using your existing formula and our certified facilities.

  • Monacolin-K content matched to spec
  • Capacity from 50,000 to 10M units monthly
  • Multi-format: capsules, tablets, sachets

Custom Formulation

Our R&D team develops proprietary blends combining red yeast rice with coenzyme Q10, berberine, policosanol, or your preferred actives.

  • Synergistic ingredient pairing
  • Bioavailability optimization
  • Stability & shelf-life testing

Bulk Ingredient Supply

Standardized red yeast rice powder and extract for distributors, nutraceutical brands, and functional food manufacturers worldwide.

  • 25kg drums, 500kg super sacks
  • Citrinin-free guarantee <50 ppb
  • Full Certificate of Analysis per batch

Private Label Production

Launch your own red yeast rice brand with low minimums, custom packaging design support, and end-to-end supply chain management.

  • MOQ from 5,000 units
  • Custom label & carton design
  • Multi-region regulatory support

Quality Testing & Analysis

In-house HPLC, mass spectrometry, and microbiology laboratories verify Monacolin-K potency, citrinin levels, and contaminant profiles for every batch.

  • HPLC quantification per USP standards
  • Heavy metals, microbes, pesticides
  • Third-party verification available

Regulatory & Compliance

Navigate FDA, EFSA, TGA, Health Canada, and NMPA frameworks with our regulatory affairs team. We prepare dossiers, structure claims, and manage filings.

  • GRAS, NDI, Novel Food dossiers
  • Label compliance for 40+ markets
  • Adverse event monitoring setup
Engagement Workflow

From brief to shipment in as little as 12 weeks

Our process is engineered for transparency. You see the lab notes, the pilot batches, the regulatory documents — every milestone is shared, signed, and stored.

01

Discovery & Brief

We align on target Monacolin-K potency, dosage form, target cost per unit, regulatory destination, and brand positioning. Output: signed specification sheet.

02

R&D & Pilot Batch

Our formulators produce 1–5kg pilot samples in your requested format. You receive COAs, stability data, and a sensory evaluation report within 3–4 weeks.

03

Scale & Validate

Full production run with in-process quality checkpoints. Every batch tested for potency, citrinin, microbial load, and dissolution before release.

04

Pack, Document, Ship

Custom packaging, market-specific labeling, regulatory dossier, and global logistics — door-to-door with temperature monitoring and full traceability.

Why Twin Horse

A manufacturing partner with scientific depth, not just a press in a warehouse

Most contract manufacturers buy raw extract, blend it, and encapsulate. We cultivate our own Monascus purpureus strains, control the fermentation curve, and ship a product where every gram is traceable back to a specific fermentation tank on a specific date.

That difference shows up in your COA — and in your customers' trust.

18+

Years of fermentation science

Our strain library and proprietary solid-state fermentation process deliver consistent Monacolin-K yields batch after batch.

<50ppb

Citrinin on every certificate

Industry-leading citrinin control using strain selection and process optimization — verified by HPLC on every single production lot.

40+

Regulatory markets served

From FDA dietary supplements to EFSA novel foods to TGA listed medicines — we have the dossiers, the relationships, and the experience.

Partner Voices

What brands say after a year of production

We measure success in reorder rates — and ours sits above 92%. Here's how a few of our long-term partners describe the working relationship.

Twin Horse's in-house fermentation is the difference. Our previous co-packer sourced generic extract and we saw 30% potency drift between batches. Since switching in 2022, our consumer complaints about inconsistent effect have dropped to near zero.
Dr. Maren Reuter Head of Product, CardioVita GmbH · Germany
The regulatory team prepared our FDA NDI notification in eight weeks and walked it through to clearance without a single deficiency letter. That alone saved us a six-month launch delay. We now have three SKUs in production with Twin Horse.
James Tanaka Founder, PureHeart Wellness · California, USA
Common Questions

Considerations before we begin

A few questions we hear often during the first conversation. If yours isn't here, our team will answer it within one business day.

What is your minimum order quantity?

For private label finished capsules, MOQ starts at 5,000 units. For bulk powder or extract, 25kg is our standard drum minimum. Custom formulation projects begin at a 50kg pilot batch.

Can you match a specific Monacolin-K percentage?

Yes. We routinely produce 0.4%, 1.5%, 2.0%, 2.5%, and 3.0% standardized extract. Custom potencies up to 5.0% are possible with extended lead time. Each batch ships with a third-party-verified COA.

How do you handle citrinin contamination?

Strain selection, controlled substrate, and real-time HPLC monitoring keep citrinin below 50 ppb on every batch — well under the strictest global thresholds. We publish the exact figure on every Certificate of Analysis.

Do you provide formulation samples?

After signing an NDA and a brief discovery call, we ship 100–500g development samples for sensory and analytical evaluation at your facility, free of charge for qualified projects.

Which certifications do you hold?

cGMP, ISO 22000, ISO 9001, HACCP, USDA Organic, EU Organic, Kosher, and Halal. Our facility is FDA-registered and inspected annually by EU and Canadian authorities.

What is the typical lead time?

Private label production: 6–10 weeks from approved artwork. Custom formulation: 12–16 weeks including pilot. Bulk ingredient: 2–4 weeks for in-stock specifications, 6–8 weeks for custom potency runs.

Bring us your spec — or just your ambition

Tell us what you need to launch, scale, or reformulate. We'll come back with a feasibility note, a price range, and a realistic timeline within two business days.

Start a Project Brief