Vetting a patch manufacturer: the twelve questions that matter

Twelve questions, and what makes them work is that each has a specific answer: an address, a certificate number, a sheet count, a line item on a quote. A manufacturer who can make your product answers all twelve from memory. One who cannot answers in adjectives, and the adjectives are the answer.

We are one of the manufacturers you may be vetting, so our own answers are in here. Where we do not publish something, we say so rather than dressing it up.

Is this the factory, or a reseller?

1. Where does the coating physically happen? Not where the company is registered, not where the sales office is, and not where the samples ship from. The address of the coating line. A transdermal patch is made by coating a formulation onto film, and the company that does that is the manufacturer; everyone else in the chain is a reseller, whatever the website says. There is nothing wrong with buying through one, provided you know you are, because the margin, the lead time and the accountability all change when you do.

Our answer: England and Plzeň, Czech Republic.

2. What construction do you make, and for how long have you made it? There are three ways to build a patch. In a matrix, the formulation is held within the adhesive layer itself. In a reservoir, it sits in a separate compartment behind a membrane. Multilayer systems combine the two. The answer tells you what the factory is set up to do, and a manufacturer who has to look it up is not a manufacturer.

Our answer: matrix, with the formulation held within the adhesive layer itself, and we have been manufacturing patches in this way for more than twenty-five years.

3. Which quality credentials do you hold, stated separately, and can I see the certificate? The three you will hear are ISO 9001, GMP and FDA registration, and they certify three different things. ISO 9001 is a quality-management standard: it says the processes are documented, audited and repeatable, and it says nothing about the product. GMP (current Good Manufacturing Practice, cGMP in the US) covers the manufacturing conditions themselves: facility, hygiene, batch records, traceability. FDA registration means the facility is listed in an FDA database. A registered facility is open to inspection at any time; the FDA does not specifically approve or license ANY non-medicinal products for sale.

Two answers should worry you. The first is any phrase that runs them together, “ISO 9001, GMP equivalent” is the common one, and it stretches a management standard to cover a practice standard. The second is FDA registration presented as a product approval, which is either careless or relies on you not knowing the difference.

Then ask for the certificate: the number, the issuing body and the expiry date. Certification bodies are slow to answer verification requests from third parties, so the document itself, with a date on it, is the practical check.

Our answer: ISO 9001; cGMP compliant; FDA registered.

Can I check what I am told?

4. What comes with a batch, and whose laboratory produced it? Ask what documentation arrives with an order (a certificate of analysis at minimum, a batch record on request) and then ask which laboratory produced the numbers on it. In-house testing is normal and not a warning sign on its own. In-house testing with no route to independent confirmation is the thing to establish before you have several thousand units in a warehouse.

5. What does a sample prove, and how long does it take? Sampling is where launch timelines die, because buyers plan for production and forget that the sample stage has its own lead time and its own limits. Ask what a sample physically is. Ours, on a formula developed for you, is three US Letter sheets (8.5 × 11 in) of coated patch film, uncut and unprinted, for ingredient and adhesive testing and nothing else. It takes 3 to 4 weeks, and it cannot show you your artwork, your patch shape or your finish. On an existing formulation there is no coating trial to wait for, because the coating has already been done. Separately, and by request, we can produce mockup (non active) print samples to allow you to see how your patch would look.

If a manufacturer offers a finished, printed, die-cut sample of a formula that does not yet exist, ask how. It is a different thing from a coating trial and should be scheduled and priced as one.

6. Who owns the formula, and can a competitor buy the same one? On our stock formulations the answer is always that a competitor can. That is what stock means, and a manufacturer implying otherwise is selling exclusivity it does not have. On a formula developed for you, the answer belongs in writing before development starts, not on the final invoice, and should cover who owns it, whether the manufacturer may sell it to anyone else, and what happens to it if you leave.

Our answer: the “Ready Made Collection” and “Your Brand, Our Formula” use existing formulations, and a competitor can buy the same formula and put a different name on it. On “Your Brand, Our Formula” the print is exclusive to you; the formula is not. “Full Bespoke” is developed for you and exclusive to you.

What will a first order actually cost?

7. Is the minimum per order or per SKU, and what is the MOQ? Suppliers in this category are not consistent about this either, and between them this can make the largest difference in what a first order costs.

Per order means one minimum split across several products.

Per SKU means each product carries the full minimum on its own.

Our answer is published. “Ready Made Collection”, 500 sheets, per order and splittable across SKUs. “Your Brand, Our Formula”, 3,000 sheets per SKU.

Full Bespoke is per SKU, set by patch size, from 40,000 (larger size patches) to 750,000 (tiny patches). Bespoke runs are based on a MOQ of 300 square metres of coated film.

8. What is in the quote, and what is not? Buyers in this category report add-ons of anywhere between a quarter and two-thirds on top of the quoted unit price. Tooling, print plates, proofs, packaging print minimums that trap more cash than the MOQ does, shipping, and a deposit. None of these is improper. All of them belong on the quote. Ask for every line item in writing, and ask specifically whether the packaging carries a minimum of its own, separate from the patch minimum, because it often does.

We give pricing, lead times and minimums in writing before you commit to anything. That is the standard to hold anyone to.

9. How is artwork proofed, and on what? A design signed off on a proof and coming back several colour shades out is named by buyers as a reason for firing a manufacturer, and it is avoidable. Ask what a physical proof is. A PDF on a screen shows you layout. It does not show you colour on coated film, colour on board or colour on pouch film, and those three surfaces take ink differently. Ask whether the proof you sign is printed, on what, and what “approved” commits each side to.

We print up to six colours on the patch itself, and we print the backing sheet and the pack. Ask us this question too.

What happens after the first order?

10. What is the reorder lead time, as distinct from the first-order one? A first order is a project: sampling, artwork, proofs, packaging tooling. A reorder should be a purchase order. Ask for the reorder lead time separately, and ask what is retained between orders (artwork files, plates, the formulation record, the packaging specification) so the second run is not a second project. Manufacturers quote first-order lead times readily and reorder times rarely, and the reorder figure is the one that decides whether you can keep a listing stocked.

11. If a batch is questioned, how far back can you trace it? GMP means batch records exist; the question is how they work when something goes wrong. From a single pack in a customer’s hand, can the manufacturer identify the batch, the date, the coating run and the raw-material lots behind it, and how long does that take? Ask who you call, and whether that person will still be there in a year. Account-manager turnover appears in nearly every account of a brand leaving a manufacturer, usually alongside missed dates and unanswered email rather than any single failure.

12. Will you tell me early if I am not a fit? The most-cited complaint about manufacturers in this category, for a decade, is silence: quotes that take a month, enquiries that go unanswered and, worse, a slow yes to an order the factory was never set up to produce. So ask directly. What is your minimum, which of your tiers does my order fall into, and if I am below it, will you say so now?

Our answer: for custom production formulas we are a bulk manufacturer and are not set up for small runs, and we would rather say that in the first conversation than the fourth. We have our stock range with smaller MOQs, but if 500 sheets is beyond what you can sell through, we will tell you, and you will not have lost a month finding out.

The twelve on one page

	Ask	The answer you want	The answer that should worry you
1	Where does the coating physically happen?	An address	“We work with partner facilities”
2	What construction, and for how long?	Matrix, reservoir or multilayer, without checking	A brochure
3	Which credentials, stated separately?	ISO 9001, GMP and FDA registration as three things, with certificates	“ISO 9001, GMP equivalent”; registration as approval
4	What comes with a batch, and whose lab?	A certificate of analysis and a named laboratory	“We test everything in-house”, and nothing further
5	What does a sample prove, and how long?	What it physically is, what it cannot show, and a number of weeks	A finished patch for a formula that does not exist yet
6	Who owns the formula?	In writing, before development	“We can sort that out later”
7	Per order or per SKU, in what unit?	Sheets, with the format named	A patch count with no format
8	What is in the quote, and what is not?	Every line item, including packaging minimums	A unit price
9	How is artwork proofed, and on what?	Printed, on the real substrate (by request)	A PDF
10	Reorder lead time, separately?	A figure, and a list of what is retained	The first-order figure again
11	How far back can you trace a batch?	Pack to batch to coating run to raw-material lots	“We have never had a problem”
12	Will you tell me early if I am not a fit?	Yes, and a minimum	Silence

Short answers

How do I check a manufacturer is actually the factory? Ask for the address of the coating line, as distinct from the registered office, and ask what construction it makes. Manufacturers answer both without hesitation; resellers answer the first with a company name and the second with a brochure.

Is FDA registered the same as FDA approved? No. Registration is a facility listing in an FDA database; a registered facility is open to inspection at any time. The FDA does not approve or license non-medicinal products for sale. We are FDA registered, and that is all the phrase means.

What should come with a batch? A certificate of analysis at minimum, with the laboratory that produced it named, and a batch record on request. Establish which lab before the first order, not after a disputed result.

Is the minimum per order or per SKU? It varies by supplier and by route, and it is the biggest swing in first-order cost. Ours is per order and splittable on the Ready Made Collection, 500 sheets, and per SKU on the other two routes: 3,000 sheets on Your Brand, Our Formula, and from 100,000 to 750,000 patches on Full Bespoke depending on patch size.

Why don’t manufacturers publish prices? Because prices move with patch size, format and volume, and a published figure goes stale fast. We are one of the ones that quote per enquiry. The standard to hold anyone to is a written quote, before commitment, listing every line item.

What is the one question most buyers forget? The reorder lead time. First-order lead times are quoted readily; the reorder figure is the one that determines whether a listing stays stocked.