5-MTHF Supplement Manufacturing Solutions
KS Nutripharma is a 5-MTHF (5-methyltetrahydrofolate) supplement manufacturer for OEM, ODM, and private-label programs. We develop finished capsules, tablets, and powder blends for prenatal vitamins, women’s multis, and methylation-focused SKUs — with a locked potency basis and COA release.
Two CoAs that both say “5-MTHF” can still be different products. Lock the finished serving, format, and assay basis before you compare price. The salt form follows that brief.
Already have a 5-MTHF CoA? Send it. We check whether the assay is salt-weight or free-acid before quoting, so the quoted potency matches a product we can manufacture.
| What to confirm before we quote | Typical project answer |
|---|---|
| 1. Target product | Finished supplement or bulk ingredient |
| 2. 5-MTHF form | Calcium / glucosamine / monosodium / “recommend” / branded input if required |
| 3. Potency | mcg free acid per serving + assay basis (salt vs free acid) — or “recommend” |
| 4. Formula direction | Single-ingredient or co-actives (B12, B6, iron, and so on) |
| 5. Format | Capsules · tablets · powder / stick packs · premix. Other formats after feasibility |
| 6. Quantity | First PO + annual forecast |
| 7. Target market | Country, channel, and price tier |
Missing a few fields is fine. Send what you have — we can recommend the rest.
Have a formula: Send BOM / RFQ · Have a CoA: Send Your 5-MTHF CoA for Comparison · Need a grade: Get a 5-MTHF Specification Recommendation
cGMP · ISO 9001 · ISO 22000 · HACCP · FSSC 22000 · Halal · Kosher · In-house lab + third-party pathways (SGS / Eurofins) · Batch COA · Traceable release
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Custom 5-MTHF Supplement Formulation for Private Label SKUs
The cards below are base formula directions, not fixed SKUs. Serving size, co-actives, dosage form, and label basis can all be customized to your product brief. KS Nutripharma’s formulation team and R&D center will match the formula to your target channel and destination market, then lock the appropriate 5-MTHF grade against the approved BOM.
Already have a BOM? Send it for formulation review.
Still selecting your formula? Choose the closest formula architecture, and we can refine the actives, dosage, format, and 5-MTHF grade with you before sampling.
Have a formula: Send BOM / RFQ
Need a 5-MTHF grade recommendation: Get a Specification Recommendation
Best for: A clean folate SKU with one declared active.
Commercial positioning: Premium standalone folate for women’s wellness or methylation-focused lines.
Core actives: 5-MTHF.
What to lock: Free-acid mcg per serving, capsule vs tablet, and whether the label will state DFE.
Manufacturing note: Keep the brief single-ingredient if iron, B12, or a mineral stack may be added later — those neighbors change the process file.
Typical formats: Capsules first; tablets when pack density leads.
Best for: Methylation / B-vitamin SKUs.
Commercial positioning: Two-active B-vitamin capsule or tablet.
Core actives: 5-MTHF + vitamin B12.
What to lock: B12 form (methylcobalamin, adenosylcobalamin, or cyanocobalamin) and both serving numbers.
Manufacturing note: Two low-dose actives in one fill. Uniformity is the work.
Typical formats: Capsules; tablets after blend-uniformity review.
Best for: A B-complex with 5-MTHF as the folate source.
Commercial positioning: Methylation-support B-complex.
Core actives: 5-MTHF + vitamin B6 + vitamin B12.
What to lock: B6 salt (including whether you want P5P), B12 form, and fill weight.
Manufacturing note: Moisture-sensitive stack. Name the salts on the RFQ so compatibility is reviewed before sampling.
Typical formats: Capsules; tablets for volume programs.
Best for: Pre-conception and pregnancy SKUs inside a women’s wellness assortment.
Commercial positioning: Prenatal or women’s nutrition SKU where folate is specified as 5-MTHF.
Core actives: 5-MTHF; iron and other prenatal nutrients as specified.
What to lock: Destination market, whether iron is in the same unit, and the folate number on the label.
Manufacturing note: Nutrient list, iron form, and label population set the manufacturing path.
Typical formats: Capsules; tablets when the multi must stay compact.
Best for: Prenatal / women’s nutrition SKUs that need both folate and iron in one serving.
Commercial positioning: Combined folate-and-iron unit for maternal-nutrition assortments.
Core actives: 5-MTHF + iron.
What to lock: Iron salt. Chelated forms such as ferrous bisglycinate are often evaluated when oxidation and GI tolerance are in the brief. Mineral stacks can be reviewed alongside calcium supplement programs when calcium is also on the BOM.
Manufacturing note: Iron, moisture, and 5-MTHF in the same blend need a development check. A capsule BOM is re-validated before a tablet run.
Typical formats: Capsules first; tablets after compatibility and compression.
Best for: A folate slot inside a women’s multivitamin or a multi-active daily SKU.
Commercial positioning: Daily multi where 5-MTHF is one slot among minerals and B-vitamins.
Core actives: 5-MTHF plus the multi stack (B-vitamins, minerals, and others as specified).
What to lock: Which actives share the unit, serving size, and format.
Manufacturing note: 5-MTHF is a micro-dose in a dense mineral blend. Cascade dilution and finished-product assay lead the file.
Typical formats: Tablets for compact multis; capsules when fill weight allows.
5-MTHF Capsules Manufacturer, Tablets, Powder & Premix
Most 5-MTHF projects start as capsules. Tablets win when volume and pack density lead. Powders and premixes serve different downstream applications and should be specified separately from the start.
Gummies, softgels, chewables, and liquids are quoted after a feasibility review. Heat, moisture, and low-pH systems can reduce 5-MTHF potency.
- 5-MTHF capsule manufacturer path
Best for: Premium, prenatal, and most first SKUs.
Why it is usually first: Two-piece capsules (HPMC / gelatin) avoid drying ovens and compression heat. HPMC shells are often preferred when the blend is hygroscopic.
What to lock: Fill weight, moisture in the shell, and the low-dose premix. Uniformity is designed in the premix before filling.
Manufacturing note: This is the fastest start for a private-label 5-MTHF SKU when heat load has to stay low. - 5-MTHF tablet manufacturer path
Best for: Multivitamins and high-volume programs.
Why tablets can beat capsules: Compact unit and better unit cost at scale when the channel wants a dense multi.
What to lock: Blend uniformity, hardness, and compression at sample — before a tablet MOQ is meaningful. Direct compression is evaluated first.
Manufacturing note: Direct compression avoids the water and heat of wet granulation. - Powder / stick packs
Best for: Drink mixes and sachets.
Why: Flexible serving weight for a different selling format than capsules or tablets.
What to lock: Blend uniformity, moisture uptake, and barrier film.
Manufacturing note: Specify powder as its own SKU from the start, including stick-pack film and desiccant. - Premix
Best for: Downstream manufacturers and multi integration.
Why: Documented dilution makes later blending easier — when the premix itself is uniform.
What to lock: Carrier, particle-size match, and the dilution ratio on the spec.
Manufacturing note: 5-MTHF is a micro-dose active. Specify a premix when the serving is too small to disperse directly in the main blend. How that premix is made — and how the finished unit is tested — is covered in the OEM risks section below.
If the RFQ only asks “can you fill 5-MTHF capsules,” these are the four issues that still reject batches.
Low-dose uniformity. A typical serving is hundreds of micrograms of 5-MTHF in several hundred milligrams of fill. The active can sit well under 0.2% of capsule weight. The failure mode is hot spots, cold spots, and a finished assay that drifts from the labeled serving. What we use against the BOM: ordered / cascade dilution, particle-size matching, humidity control during blend, transfer and hopper controls, and stratified sampling (blend uniformity, then content uniformity).
Raw CoA vs finished-product assay. Finished units are assayed against the agreed method. The incoming salt CoA supports identity and input potency. HPLC sample prep typically includes an antioxidant (often ascorbic acid) to protect the analyte during extraction.
Moisture, oxygen, heat, and light. Loss is oxidation-led; heat, light, and water speed it up. Direct compression, dry granulation, or premix-to-fill are evaluated before wet granulation.
Compatibility. Iron, unchelated mineral salts, acidic ingredients, and hygroscopic materials (certain citrates, choline salts) need a development check in the same blend. Folate, folic acid, 5-MTHF, and DFE also follow the destination market — name the country before the formula is locked.
A PO line for 5-MTHF needs salt, hydrate, assay basis, isomer, and carrier locked before you compare kilograms.
Salt form | What you are buying | Where it usually fits | What to confirm on the CoA |
|---|---|---|---|
| Calcium salt, anhydrous | (6S)-5-MTHF calcium · CAS 151533-22-1 · ~92.4% free acid | Capsules, tablets, dry premixes | Hydrate stated as anhydrous; assay basis |
| Calcium salt, trihydrate | Same CAS family · ~83.3% free acid | Solid orals when the file specifies the trihydrate | Water of hydration in the serving math |
| Glucosamine salt (1:2) | CAS 1181972-37-1 · ~56.2% free acid | Higher-solubility powders; liquid / softgel feasibility | Same free-acid target needs more salt by weight |
| Monosodium salt | EU Novel Food (EU 2024/1037) · ≥95% as 5-MTHF, Na 4%–5% | EU-scoped SKUs that accept this source | Market authorization for this salt — scoped per destination |
Other salts (including magnesium) are quoted when supply and the destination file support them.
If the brief requires a branded input, name it on the RFQ. Default quoting is by chemical form and specification.
Same “5-MTHF” on three CoAs can still be three quotes
What the CoA actually describes | Why the kilograms still need normalizing |
|---|---|
| Supplier A — calcium salt, salt-basis assay | Higher free-acid yield per gram of salt |
| Supplier B — glucosamine salt, free-acid basis | More salt mass per labeled serving |
| Supplier C — branded input and a carrier | You are buying a branded system plus carrier |
Cost per labeled serving can still be higher at a lower $/kg.
Do not compare 5-MTHF by weight alone. Compare free-acid contribution, salt form, assay basis, and the finished-product specification. Send the current CoA and we will normalize the numbers before you compare price.
Have a CoA: Send Your 5-MTHF CoA for Comparison
Salt weight, free-acid 5-MTHF, and DFE are three different numbers. The correct calculation depends on the salt form, assay basis, and destination market.
Raw material weight × assay × free-acid equivalence = actual 5-MTHF (free acid)
Then apply the DFE rule for that market.
| Salt form | Free-acid share (approx.) | Salt needed for 400 mcg free acid at 99% assay |
|---|---|---|
| Calcium, anhydrous | ~92.4% | ~437 mcg salt / serving |
| Calcium, trihydrate | ~83.3% | ~485 mcg salt / serving |
| Glucosamine (1:2) | ~56.2% | ~719 mcg salt / serving |
| Monosodium | Use the 5-MTHF assay on the CoA (EU spec typically ≥95% as 5-MTHF) | Use that assay as the only conversion factor |
A 99% anhydrous calcium salt on a salt-weight CoA is about 91.5% free acid. When one supplier quotes salt-basis and another quotes free-acid, normalize both to free acid before you compare serving cost.
United States. Supplement Facts declare folate in mcg DFE (21 CFR 101.36). Conversion for L-5-MTHF is expected to stay at or below 1.7. Illustration only: 400 mcg free-acid 5-MTHF × 1.7 = 680 mcg DFE. Final copy stays with the brand and counsel.
European Union. EFSA 2022 uses 1.7 below 400 mcg/day supplemental 5-MTHF and 2.0 at or above 400 mcg/day. Use the EU factor on EU labels only.
Other markets. Send the destination file. UK, Canada, and Australia are scoped from that file.
Mainstream briefs usually sit in the hundreds of micrograms of free-acid 5-MTHF per serving (400 mcg and 1,000 mcg are common starting points). Strengths such as 5 mg, 7.5 mg, or 15 mg are a destination-market and documentation decision. Confirm that file before the formula is locked.
What you will receive with the batch?
As scoped on the project: batch COA, approved specification, finished-product test results, traceability from input lot to production batch, packaging specification, sample approval, and release documentation. In-house release is standard. SGS or Eurofins can be added when the RFQ requires a third-party pack. Methods: Quality Control.
What buyers should check on the file?
Identity and salt form · assay and basis (salt vs free acid) · (6S) isomer vs D-isomer · related substances · moisture · heavy metals and microbiology per destination market · residual solvents when required · particle size when uniformity is in scope · finished-unit content uniformity · stability files for raw material and finished product kept separate.
Limits follow the approved specification and destination market. Content uniformity follows the agreed pharmacopoeia for that file.
We develop to the documentation requirements of the market you name. Brand owners confirm finished-label compliance with local counsel.
| Market | What to settle before the formula is locked |
|---|---|
| United States | Dietary-supplement path (DSHEA). Folate in mcg DFE on Supplement Facts; L-5-MTHF conversion expected to stay at or below 1.7. Brand owner owns structure/function wording. 7.5 mg / 15 mg needs its own documentation path. |
| European Union | Calcium and glucosamine salts are established folate sources. Monosodium salt is a Novel Food (EFSA 2023; EU 2024/1037). DFE follows EFSA 2022, including the intake-bracket change. |
| UK, Canada, Australia | Separate files. Send destination, claim pathway, and whether you need NPN / TGA / GB documentation support. |
| China | 2017 approval covers (6S)-5-methyltetrahydrofolate calcium as a nutritional fortifier for formulated milk powder (excluding infant and maternal milk powder) and solid beverages. Glucosamine salt quality standard: GB 1903.75-2025. Export dietary supplements follow a different file than GB 14880 food categories. |
Tell us the target market before we lock the grade.
Need a grade: Get a 5-MTHF Specification Recommendation
For 5-MTHF, the pack is part of the formula.
Bulk ingredient: foil bag or drum, with desiccant and inert-gas flush as the grade requires.
Finished SKUs: bottles, blisters, sachets, and cartons as scoped.
Pack direction | When it is the right job |
|---|---|
| HDPE / PET + induction seal + desiccant | Usual start for capsules and tablets |
| Alu-Alu blister | Higher barrier — humid routes, premium count |
| Foil stick / sachet (optional nitrogen) | Powders and premixes |
| Amber / light-protective pack | When light exposure is in the risk file |
| Clear plastic, no barrier | High moisture and light risk — other options are evaluated first |
Finished-product shelf life is established from formulation, packaging, storage, and stability data. Store unopened material cool, dry, and protected from light.
Indicative starting ranges. Final MOQ is confirmed after the formula, packaging, testing scope, and production requirements are locked. Typical lead times sit with the process stages below.
Typical MOQ by Product Format
5-MTHF bulk ingredient
Typical start: Project-dependent, quoted by kg / lot
What usually drives the minimum: Salt form, specification, and bulk pack.
Capsules
Typical start: ~3,000–5,000 units
What usually drives the minimum: Capsule size, fill weight, and finished pack.
Tablets
Typical start: ~5,000–10,000 units
What usually drives the minimum: Compression at sample, tablet spec, and pack.
Powder/granules — bulk
Typical start: Quoted by kg
What usually drives the minimum: Specification and drum / bag.
Powder — retail/stick
Typical start: Often from ~10,000 units
What usually drives the minimum: Film, fill weight, and moisture barrier.
Gummies / softgels
Typical start: Project-scoped
What usually drives the minimum: Heat/moisture feasibility, tooling, and pack.
Bulk kilograms and finished units are different production stages — quote them on separate lines.
Have a formula: Send BOM / RFQ
The seven fields in the opening table are enough for a first technical reply — typically within two business days. Missing fields can be recommended after we see the market, format, and serving target. A locked BOM with in-stock inputs and a specified pack moves faster than a new flavored powder or a gummy feasibility project.
01 — Brief. Market, label number, format, pack, volume.
02 — Grade and formula review. Salt, assay basis, compatibility. Duration is project-dependent — destination market, serving target, and whether a BOM or CoA is already in hand.
03 — Sample. You approve a prototype before pilot metal is committed. Typical: 7–15 days*, driven by formula complexity, input availability, and pack specification.
04 — Pilot. Blend uniformity, fill or compression, QC. Typical: 15–25 days*, plus any feasibility work (for example gummies or softgels).
05 — Mass production. Batch manufacture, testing, pack. Typical: 30–45 days*, driven by order volume, packaging, testing, and production schedule.
06 — Release and ship. COA, batch records, dispatch.
Subject to formula, pack, testing, and schedule.
| Path | What you provide | What you can receive |
|---|---|---|
| OEM | Locked BOM and specification | Manufacturability review, then production against the approved spec |
| ODM | Market, format, potency target or “recommend,” volume | Grade, formula architecture, and production spec |
| Private label | Brand, pack, and a custom or agreed formula | Finished SKU under your brand |
| Bulk ingredient | Salt form, assay basis, and pack | Qualified 5-MTHF material for downstream manufacturing |
Have a formula: Send BOM / RFQ · Need a grade: Get a 5-MTHF Specification Recommendation
KS Nutripharma manufactures finished 5-MTHF capsules, tablets, and powder blends on the same program as formulation development and in-house release. Stick packs are quoted when barrier film and moisture control are specified. Gummies and softgels run on existing lines; for 5-MTHF they are scoped after a feasibility review.
Bulk 5-MTHF is available as an ingredient PO when you are blending downstream. It is quoted separately from a finished SKU — different MOQ, pack, and release file — so each stage sits on its own line.
Since 2007, KS Nutripharma has operated five bases totaling 81,000+ m², with 2 R&D centers, 12 automated production lines, and 260+ professionals, supporting 500+ brand projects in 60+ export markets.
- cGMP · ISO 9001 · ISO 22000 · HACCP · FSSC 22000 · Halal · Kosher.
- Site-level capacity: Manufacturing Capacity.
Get a 5-MTHF Supplement Manufacturer Quote You Can Put on a PO
Send the market the SKU will sell into, the number you want on the label, and whether that number is salt weight, free acid, or DFE. Those three fields let quotes line up. If the formula is still open, say so. We will tell you what to lock so you are comparing a manufacturable finished product.
A market, a serving target, and a format are enough to start. If you already have a CoA or a BOM, send that. We check whether you are pricing the same 5-MTHF before you spend a sampling cycle.
- Have a formula: Send BOM / RFQ
- Have a CoA: Send Your 5-MTHF CoA for Comparison
- Need a grade: Get a 5-MTHF Specification Recommendation
