Private label supplement manufacturing for the US market
Manufactured in Mārupe, Latvia, European Union.
In the United States a dietary supplement is not approved by the FDA before sale: the brand on the label answers for it, and the importer verifies the foreign plant. PharmaEurope manufactures at an ISO 22000-certified plant in Mārupe, Latvia, registered with the US FDA as a food facility (13674831934): from 100 units on ready-made formulas, 500 bottles as the standard run, with the documents your importer’s verification is built on.
In short: we manufacture, test and document; your US importer files Prior Notice and keeps the supplier verification file; your brand is on the label and responsible under US law.
MOQ, production time and documents for the US market
The figures a US brand and its importer ask for before the first order.
| Item | Detail |
|---|---|
| Standard run | 500 bottles of capsules or tablets per product; 300 kg of finished blend for powders |
| First run | From 100 units on ready-made formulas |
| Production | 4 to 8 weeks from approved formula and label artwork |
| FDA | Food facility registration 13674831934: a registration, not an approval; renewed every two years, between October and December of even years |
| With every batch | Specification, Certificate of Analysis, site certificates: ISO 22000 MSC-22-1384, GMP-FS-01, HACCP-01 |
| Your US importer | Keeps the Foreign Supplier Verification Program file and files Prior Notice before every shipment arrives |
| Label | Designed and printed at the plant: Supplement Facts panel, “dietary supplement”, net quantity, your name and place of business, a US address or phone number for adverse event reports |
| Duty | Set by the HTS code of the product; tariffs on EU goods changed in 2025, so your customs broker confirms the current rate |
Does an EU plant have to meet US cGMP?
Yes. 21 CFR Part 111, the US current good manufacturing practice rule for dietary supplements, applies to foreign plants that make products for the US market as much as to domestic ones, and the FDA inspects foreign plants. ISO 22000, GMP and HACCP certification is a strong foundation, but US law judges compliance against Part 111 itself, so your importer verifies the plant through its supplier verification file. We supply the specification, the Certificate of Analysis for each batch and the site certificates, and visits and audits by customers can be arranged: your importer can see the plant.
“A batch does not leave the warehouse without a clean test report and a Certificate of Analysis. At the final stage we check the physical parameters — average weight, uniformity of mass and disintegration time; microbiological purity — yeasts and moulds within limits, no E. coli and no Salmonella — and heavy metals; the assay, meaning the real content of each active ingredient against what your label declares; and the seal — the induction membrane and the closure — so the product does not oxidise or take on moisture in transit.”
How do EU-made supplements get to the US?
1. Formula and label
We design the US label: Supplement Facts in US units, with vitamin D in micrograms, and your US contact for adverse event reports.
2. Production
4 to 8 weeks at our plant in Mārupe, Latvia. The batch is released with its Certificate of Analysis.
3. Export from the EU
FCA or DAP recommended for the US; EXW Mārupe on request. The invoice carries no EU VAT once the export is proven.
4. Arrival in the US
Your importer or its broker files Prior Notice before the goods arrive; the FDA can examine a shipment at entry.
5. On sale
In your own store, in retail or on Amazon US, with your brand as the company responsible for the product.
Questions about manufacturing supplements for the US market
Is the product FDA approved?
No dietary supplement is approved by the FDA before sale. The company named on the label is responsible for the safety of the product and for the truth of its claims. Our plant holds US FDA food facility registration 13674831934, which is a registration and not an approval or certification of the plant or its products.
Is ISO 22000 the same as US cGMP?
No. ISO 22000, GMP and HACCP are complementary systems, not a substitute for 21 CFR Part 111. Compliance with Part 111 is shown on its own terms, through specifications, testing and records, and your importer verifies it in its supplier verification file.
Who files Prior Notice and the FSVP file?
Your US importer. Dietary supplements have modified Foreign Supplier Verification Program requirements, set out in 21 CFR 1.511, that focus on the plant’s compliance with Part 111. Prior Notice is filed by the importer or its customs broker before each shipment arrives. We supply the documents both rely on.
What must the US label carry?
A Supplement Facts panel, the statement of identity with the words “dietary supplement”, the net quantity, and the name and place of business of the company responsible, plus a US address or phone number where adverse events can be reported. We design and print the label; the US contact details are your company’s.
Can the label carry structure/function claims?
Only with the FDA disclaimer printed on the label, and the company responsible must notify the FDA within 30 days of first marketing a product with such a claim. The notification is filed by your brand.
Can we sell on Amazon US?
Yes, as the seller of record. Amazon US asks dietary supplement sellers for test results from an accredited laboratory and for GMP documents, and verifies them through third-party organisations. We supply the Certificate of Analysis and the specification for every batch, and testing by an independent accredited laboratory can be arranged on request.
What is the minimum order for the US?
The same as for Europe: from 100 units on ready-made formulas, 500 bottles per product as the standard run, and 300 kg of finished blend for powders. The full table is on the minimum order quantities page.
Which formats can you make for the US market?
Capsules, tablets, softgels, effervescent tablets, powders, sachets, sports nutrition, syrups and vitamin oils, all made at the plant in Mārupe, Latvia. The full range is on the formats page.
Can you manufacture our own formula?
Yes. A formula developed from your brief starts from 500 bottles per product for capsules and tablets and 300 kg of finished blend for powders. It is turned into a sample first, and nothing is produced before you approve it. If the formula contains a new dietary ingredient, the US brand notifies the FDA at least 75 days before marketing it.
Which ready-made formulas start from 100 units?
Ready-made formulas in capsules, tablets and softgels start from 100 units in stock packaging. Effervescent tablets have a low minimum quoted per tube count, and powders start from 300 kg of finished blend. The catalogue is on the ready-made formulas page.
Do the 4 to 8 weeks include shipping to the US?
No. 4 to 8 weeks is production, counted from approval of the formula and the label artwork. Transit, Prior Notice and entry at the US port come on top of that.
Which documents do you give our importer?
A specification, the Certificate of Analysis for the batch and copies of the site certificates: ISO 22000 MSC-22-1384, GMP-FS-01 and HACCP-01. Your importer uses them in its supplier verification file, together with the plant’s FDA food facility registration 13674831934.
Can we get samples before ordering?
Yes. Samples of existing products are sent to companies that are seriously considering an order, so you can see the product, the pack and the label before the first batch.
Sources
- Dietary Supplement Health and Education Act of 1994; FDA, Dietary supplements: fda.gov.
- 21 CFR Part 111, current good manufacturing practice for dietary supplements: ecfr.gov.
- 21 CFR Part 1, subpart H (food facility registration), subpart I (Prior Notice) and subpart L (Foreign Supplier Verification Programs, section 1.511).
- 21 CFR 101.36 (Supplement Facts) and 101.93 (structure/function claims); 21 U.S.C. 379aa-1 (adverse event reporting).
Checked on 24 September 2026. Rules and rates change: your importer and customs broker confirm them for your product.
Tell us your formula and your market
Tell us the category, the serving size and how many units you need for the first run, and we will come back with the blend, the flavour options and a price for that quantity.