FREQUENTLY ASKED QUESTIONS

Contract manufacturing of patches and topical preparations.

The questions buyers ask before a first meeting, answered directly. If something here is unclear for your project, write to services@3mast.com.tw.

01The company and its credentials

What does Three Mast manufacture?

We manufacture medicated patches and topical preparations on a contract basis for OEM and ODM clients. The company was founded in 1982 in Tainan, Taiwan, and has focused on topical dosage forms since then. The suitable format for a given project is decided from the formulation rather than chosen in advance.

What GMP certification does Three Mast hold?

Both of our plants in Tainan hold GMP certificates from Taiwan’s Ministry of Health and Welfare under the GMP standard for traditional Chinese medicine (certificates (C)0000066 and (C)0000109). Our Yongke plant also holds a Certificate of GMP Compliance from Australia’s TGA for non-sterile dermal patches, assessed against the PIC/S GMP Guide (certificate MI-2024-CE-10010-1, valid to May 2027). We provide certificate copies on request as part of project due diligence.

Have your products been manufactured for regulated markets outside Taiwan?

Yes. Three Mast is listed as the manufacturer for Australian listed medicines AUST L 522687 and AUST L 522689. Being listed as a manufacturer on the ARTG record is a manufacturing credential; it is not a certification claim, and we describe it only in those terms.

Where are your manufacturing sites?

We operate two production sites in Tainan, Taiwan. Site visits and audits by prospective clients are arranged case by case. We do not publish internal line layouts, control interfaces or process parameters.

02Making a multi-ingredient topical

What limits the number of ingredients in one topical product?

Compatibility, not capacity. Every additional botanical extract, essential oil or functional excipient multiplies the ways a batch can fail — discolouration, phase separation, adhesion loss, pH drift, or the loss of the volatile compounds that define how a product feels on skin. Standardising one molecule is a known problem; keeping a dozen of them stable, adherent and reproducible to the end of shelf life is a different discipline.

Why do thin patches often lose their sensory effect?

Because the process cannot retain the volatiles, not because the formula lacks them. Compounds that carry cooling or warming sensation evaporate during coating and drying. Retaining them is a matter of coating temperature, drying profile, order of addition, and in some cases encapsulation — which is why the same formulation can feel completely different coming off two different lines.

How do you choose a delivery format for a multi-ingredient formulation?

The formulation decides the format. Lipophilic components and hydrophilic components will separate if forced into the wrong matrix, so we route them by polarity before anything else is fixed. We tell clients at proposal stage which direction a given ingredient set points to, rather than selling a preferred format and adapting the formula to it.

Can sensory attributes be written into a specification?

Yes. Onset time, intensity and duration of sensory effect can be defined, measured and accepted as specification items, alongside assay and adhesion. Treating sensory performance as a specification rather than an outcome is what makes a product reproducible across batches.

Can the duration of wear be designed?

Yes. Matrix viscosity, mass layer thickness and backing permeability determine how quickly the actives are released, so an eight-hour product and a short, high-intensity product are two different manufacturing problems. We design them separately rather than sharing one formulation across both.

03Working together

Do you require a minimum order quantity?

We do not set a fixed MOQ in advance. Each project is assessed across four dimensions — target market, sales channel, product and dosage form, and development and manufacturing scope — and the workable quantity falls out of that assessment. Packaging decisions, particularly printed materials, usually drive the floor more than the production run itself.

What are the stages of an OEM project?

Inquiry, sampling, trial production, then mass production. Lead time depends on the dosage form, the packaging route and the regulatory pathway in the destination market, so we give a schedule after the formulation and market are defined rather than quoting a standard duration.

Who holds the product registration in an OEM project?

The client holds the market authorisation. We manufacture to the agreed specification and provide the manufacturing and quality documentation required to support the client’s filing. Regulatory status — medicine, cosmetic or general merchandise — is determined by the destination market, not by the factory.

Can you support overseas registration documentation?

Yes, within the manufacturing scope. We provide specifications, manufacturing and quality documentation, and stability data to support a client’s submission. We do not act as the applicant, and we do not advise on claim strategy in the destination market.

What claims can be made on the finished product?

Only what the destination market permits for the product’s regulatory category — and that is the client’s decision, not ours. We do not state or imply therapeutic effect in any material we produce. Where a format is often misdescribed, we are explicit about what it does: microneedle delivery reaches the stratum corneum only, and ultra-thin patches provide physical covering and moisture retention.

What should I prepare for a first inquiry?

Target market, sales channel, product concept, and intended quantity and timing — those four are enough to start. Please do not send complete formulations or end-customer names in a first inquiry; we will tell you when a confidentiality agreement is in place and what level of detail is useful at that point.

NEXT STEP

Market, channel, product concept, quantity and timing.
That is enough to start a conversation.

services@3mast.com.tw How we work