Small Lots & OEM

You can bring us the product form, not only the material. Through our health-food OEM/ODM affiliate (TENMARU SEIYAKU Co., Ltd.), material selection, formulation design and manufacture run through one point of contact — including at the stage where only the claim is settled.

1. The dose decides the dosage form

The order is claim → component amount → material quantity → dosage form. Starting from the other end leads to a dead end.

Scale of the daily doseTypical materialsForms that fit
μg to a few mgGlucosylceramide (1.2 mg), vitamin DComfortably in a tablet or capsule
Tens of mgLutein 10 mg + zeaxanthin 2 mgTablet, softgel
Tens of mgBilberry-derived anthocyanins 43.2 mgTablet, capsule
Hundreds of mg to 1 gGABA, collagen peptide (low end)Tablet count rises; powder is easier
Several gramsInulin 4.5 g, collagen peptide 2–5 gNot realistic as a tablet. Powder, stick, beverage

Inulin shows this plainly. The most common notified dose is 4.5 g, which will not fit in a tablet. The same dataset also holds a substantial number of 750 mg designs, which leave the form open. By the time the dose is set, the form is largely decided.

2. Material properties constrain the process

  • Oil-soluble — carotenoids such as lutein and astaxanthin suit softgels or emulsified preparations; for tableting, choose a prepared form
  • Hygroscopic — the free base of L-carnitine is hygroscopic, which affects tablet hardness and storage stability. Choosing a salt form can avoid it
  • Particle size — tableting needs flow and fill behaviour; powder filling needs resistance to segregation. The same substance is often offered in several particle-size grades
  • Heat resistance — spore-forming bacteria tolerate heat, which is precisely why they are designed in at 100 million cells. The design assumes that resistance, so changes to heat conditions call for a check
  • Weighing precision — for materials dosed in small amounts, a premix reduces weighing error by an order of magnitude

3. Starting from trials and small lots

We take enquiries from trial and small-lot volumes. If scale-up is in view, settling these at the trial stage saves work later.

  • Whether a single lot can cover the run, and continuity of specification across lots
  • Lead time and minimum order quantity at scale
  • The format required for specifications and COAs (share it in advance if the recipient is fixed)
  • Regulatory confirmation — particularly for imported materials and the human/animal distinction

4. If a function claim is intended

Choose a material that can be identified as the functional ingredient from the selection stage. Substituting later is expensive.

  • For bacteria, choose a material whose name carries the strain — a generic name cannot be designed on
  • For extracts, fix the content basis first
  • Set the target against live comparable notifications and their doses
  • Confirm early that the dose and the intended form can coexist

See Regulatory Support for detail.

What to tell us

  • The claim direction — the material may be undecided
  • Target component amount — if set; otherwise we propose one
  • Intended dosage form — if undecided, we work back from the dose
  • Whether a function claim is in view — it changes material selection
  • Expected quantity and schedule

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