Nutraceutical Manufacturing in Europe: What a Food Supplement Contract Manufacturer Does, from Brief to Batch
Nutraceutical manufacturing in Europe is food supplement manufacturing: EU law has no nutraceutical category, and nutraceuticals sold in dose form as food supplements fall under Directive 2002/46/EC as foods, not medicines. Pharma Manufacture makes them at its factory in Mārupe, Latvia, from 150 units of a ready-made tablet or capsule formula, with production from 4 weeks, and releases every batch with a Certificate of Analysis.
| Parameter | Pharma Manufacture |
|---|---|
| Legal category in the EU | Food supplements, Directive 2002/46/EC; not medicinal products |
| Factory | “Kargo k-1”, Mārupe, LV-2167, Latvia; more than 50 people; four production lines |
| Forms | Tablets, hard capsules (gelatin or vegan HPMC), softgels, effervescent tablets, drink cubes, powder sachets, drops, syrups, shots, sports nutrition powders |
| Formulas | 350 ready-made in the catalogue, or your own formula |
| Minimum order | From 150 units for a ready-made tablet or capsule formula; from 80,000 powder sachets; other forms quoted within 24 hours |
| Lead time | From 4 weeks; about 8 weeks for a typical run, from confirmed order and technical brief |
| Release | Tablets, capsules and softgels held in quarantine until microbiological testing and heavy metals limit control clear them; metal detection; a Certificate of Analysis for every batch |
| Certificates | GMP-FS-01 and HACCP-01, valid to 17 May 2027; ISO 22000:2018 MSC-22-1384, valid to 7 January 2029 |
What follows is the frame a buyer needs before choosing a factory: what the law calls the product, what a contract manufacturer does and what stays with the brand, which forms are made in Mārupe, and what comes with each batch. The factory itself, with its certificates and lines, is on the manufacturing page.
Key Takeaways
- “Nutraceutical” is a market word. The EU legal category is the food supplement: a food in dose form that supplements the normal diet, under Directive 2002/46/EC.
- The directive does not apply to medicinal products, and a supplement’s label, presentation and advertising must not attribute to it the property of preventing, treating or curing a human disease.
- A contract manufacturer makes, tests and releases the batch; the brand on the label places the product on the market, files any national notification and answers for the label and the claims.
- At Pharma Manufacture a ready-made tablet or capsule formula starts from 150 units and takes from 4 weeks; your own formula starts higher and adds a formula calculation and a validation batch.
- Every released batch ships with a Certificate of Analysis, and the batch number on the pack leads back to it, to a sample kept at least three years and to records kept 10 years.
What is nutraceutical manufacturing, and what does EU law call it?
Nutraceutical manufacturing is the making of concentrated nutrients and other substances in measured doses, and in the EU those products are food supplements. Directive 2002/46/EC defines food supplements as foodstuffs that supplement the normal diet and are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form (Article 2(a)).
The dose forms the directive names are the ones a supplement factory runs: capsules, pastilles, tablets, pills, sachets of powder, ampoules of liquids, drop dispensing bottles and similar forms of liquids and powders taken in measured small unit quantities. “Nutrients” in the directive means vitamins and minerals (Article 2(b)), and only the vitamins and minerals in its Annex I, in the forms listed in Annex II, may be used to make food supplements (Article 4(1)).
The word “nutraceutical” does not appear in the directive as adopted. A buyer searching for a nutraceutical manufacturer in Europe is, in legal terms, looking for a food supplement manufacturer, and the product will be sold under the name “food supplement” (Article 6(1)).
Food supplement or medicine: where does a nutraceutical sit in EU law?
On the food side. Directive 2002/46/EC concerns food supplements marketed as foodstuffs and presented as such, and it does not apply to medicinal products as defined by Directive 2001/83/EC (Article 1). The line is drawn by what the product is and how it is presented, and the label is where it shows first.
| Question | Food supplement under Directive 2002/46/EC |
|---|---|
| Name on the label | “Food supplement” (Article 6(1)) |
| Disease claims | Labelling, presentation and advertising must not attribute the property of preventing, treating or curing a human disease (Article 6(2)) |
| Vitamins and minerals allowed | Those in Annex I, in the forms in Annex II (Article 4(1)) |
| Maximum amounts | Provided for in Article 5, but no single EU maximum is set; limits differ by country |
| Mandatory label items | Nutrient categories, daily portion, warning not to exceed it, not a substitute for a varied diet, out of reach of young children (Article 6(3)) |
| Placing on the market | A member state may require a notification with a model of the label (Article 10) |
| Health claims | Regulation (EC) No 1924/2006, with the authorised claims in Regulation (EU) No 432/2012 |
| Delivery to the consumer | Pre-packaged only (Article 1(1)) |
For a buyer, the practical difference is this. A product built as a food supplement goes to market through a notification where the country requires one, not through a medicine’s route, and every health claim on the pack has to be permitted under Regulation (EC) No 1924/2006. Pharma Manufacture makes food supplements; how the label text is built is covered in supplement label design for the EU.
Which nutraceutical forms does Pharma Manufacture make?
Ten, across four production lines for tablets and capsules, powders, effervescent products and liquid forms. Each form has its own minimum, because a different part of the product sets it: the formula for tablets and capsules, the tube for effervescent tablets, the laminate roll for sachets.
| Form | What is made | Minimum order | Lead time |
|---|---|---|---|
| Tablets | Direct compression; round 7.5, 9, 11 and 13 mm, oval 16×8 to 22×10 mm | From 150 units, ready-made formula | From 4 weeks |
| Hard capsules | Gelatin or vegan HPMC, sizes #1, #0, #00 | From 150 units, ready-made formula | From 4 weeks |
| Softgels | Oval #3, #8, #10, #20; gelatin, glycerin and water shell | Set by size and fill, quoted within 24 hours | From 4 weeks |
| Effervescent tablets | In tubes, 26 ready-made formulas; brand by IML, offset or label | Set by the tube, quoted within 24 hours | From 4 weeks |
| Drink cubes | Compressed effervescent cube, each in its own blister | Set per product | Quoted with the minimum |
| Powder sachets | 4 to 12 g, three-layer laminate printed with your brand | From 80,000 sachets | About 8 weeks |
| Drops | 20–30 ml amber glass bottles with a dropper | Set by bottle, closure and formula | From 4 weeks |
| Syrups | Amber glass bottles of about 200–250 ml | Set by bottle, closure and formula | From 4 weeks |
| Shots | One serving per pack | Set by bottle, closure and formula | From 4 weeks |
| Sports nutrition powders | Proteins, creatine, amino acids, complexes; 30+ ready-made formulas; jars or doypacks | Set by the pack, quoted within 24 hours | From 4 weeks |
Tablets are compressed on an IMA PREXIMA 300 rotary press, capsules filled on an IMA PRACTICA 100, blisters formed and sealed on an Uhlmann B 1240, bottles counted on a Cremer CF 1220 and cartons closed on an IMA IC 150; the makers’ data is on the equipment page. The formulas by form are on the tablets, capsules and softgels page, the effervescent tablets page, the powder sachets page and the liquid forms page. Why the minimum moves with the form is explained in which supplement form starts with the smallest order.
Ready-made formula or your own: which route fits?
A ready-made formula is the shorter route; your own formula is built to your brief. The trade-off is a longer lead time and a higher minimum in exchange for a formula built around your product.
| Ready-made formula | Your own formula | |
|---|---|---|
| Starting point | One of 350 catalogue formulas | Your ingredients and dose per serving, or a concept the R&D team works through with you |
| First check | Recipe, sourcing and paperwork already exist | Formula calculation: can it be produced, and in which form |
| Doses | Checked against the rules of the country of sale | Checked against the rules of the country of sale |
| Before the run | Approval of a sample | A validation batch, made once for a new formula |
| Minimum order | From 150 units in tablets or capsules | Higher, because development and the validation batch are paid for once |
| Lead time | From 4 weeks | Longer; planned around the quote |
The in-house R&D team of pharmacists, biochemists, dieticians and nutritionists also adapts catalogue formulas; an adapted formula follows the same route as a custom one. The fuller comparison is in how to choose a supplement form and formula.
From brief to batch: how a nutraceutical order runs at Pharma Manufacture
Nine steps for a first order; a repeat of an existing formula in existing packaging is mostly a question of scheduling. The lead time is counted from step five, when the factory has both the confirmed order and the technical brief.
| Step | You | Pharma Manufacture |
|---|---|---|
| 1. Enquiry | Name the product or send your full list | Replies within 24 hours with a price list |
| 2. Formula | Choose a catalogue formula or send yours | Formula calculation; R&D checks doses against the rules of the country of sale |
| 3. Samples | Ask for samples of ready-made formulas | Sends them on request |
| 4. Pack and label | Choose the pack; supply or approve the label text | Designer prepares the artwork; label design help is part of the service |
| 5. Order | Confirm the order and the technical brief | Lead time starts |
| 6. Raw materials | Sampled and tested against specification before use | |
| 7. Production and packing | Approve a sample of your product before the run | Weighing and sieving, blending in V-type mixers with in-process samples, then pressing, encapsulation or filling, and packing |
| 8. Release | Finished tablets, capsules and softgels wait in quarantine until microbiology and heavy metals control clear them; metal detection; Certificate of Analysis | |
| 9. Delivery | Give the delivery address | Delivers to your warehouse anywhere in the EU, or you collect in Mārupe |
Two things move the date more often than the run itself: raw material availability and how quickly the artwork is approved. A formula built from scratch adds development and a validation batch before step seven. What a factory needs in the first message is in what a manufacturer needs to quote your first order.
Which documents come with every batch?
A Certificate of Analysis for the released batch, whatever the order size. The batch number and expiry date printed on the blister and the carton link each pack to its batch and its certificate.
| Document or record | What it covers | Kept or valid |
|---|---|---|
| Certificate of Analysis | Your batch, released after microbiological testing and heavy metals control | One per released batch |
| GMP-FS-01 | Food Supplements Europe Guide to Good Manufacturing Practice | 28 April 2026 to 17 May 2027 |
| HACCP-01 | Regulation (EC) No 852/2004 on the hygiene of foodstuffs | 28 April 2026 to 17 May 2027 |
| ISO 22000:2018 MSC-22-1384 | Food safety management system | 8 January 2026 to 7 January 2029 |
| EU Certificate of Conformity | Packing materials, with a quality analysis per batch of material | Per batch of material |
| Retained sample | Every finished batch | The product’s shelf life and at least three years |
| Manufacturing data | Full traceability through the supply chain | 10 years |
The three plant certificates, GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384, were issued by BM Certification SIA in Riga, and their printed scope is manufacturing and packaging of food supplements in tablets, capsules and powders; for a form the scope line does not name word for word, ask which document covers its line before the certificate goes into your file. Scans are on the certificates page.
A batch that fails release stays in quarantine and does not ship. If a defect is found after delivery, the batch number leads to the production record, the Certificate of Analysis and the retained sample of that batch.
What stays with the brand: notification, label and claims
Placing the product on the market is the brand’s job. In private label, the business whose name is on the label files any national notification and answers for the label under Regulation (EU) No 1169/2011 and for every claim under Regulation (EC) No 1924/2006. Pharma Manufacture supplies the batch documents for that file.
The notification is national. Article 10 of Directive 2002/46/EC lets a member state require the manufacturer or the person placing the product on its market to notify the competent authority by sending a model of the label, and each country runs its own procedure. Doses are national too: Article 5 provides for maximum amounts of vitamins and minerals, but the EU has set no single maximum, so the formula is checked for the country of sale. That is why the market belongs in the first message to a factory, before the formula and the label are fixed. Who files what, country by country, is on who files the notification in your country.
Frequently asked questions
Is a nutraceutical a food supplement or a medicine in the EU?
In the EU a nutraceutical in dose form is sold as a food supplement under Directive 2002/46/EC; the directive does not apply to medicinal products as defined by Directive 2001/83/EC. Its label must not attribute to it the property of preventing, treating or curing a human disease. Pharma Manufacture makes them as food supplements at its factory in Mārupe, Latvia.
Which nutraceutical forms does Pharma Manufacture produce?
Tablets, hard capsules in gelatin or vegan HPMC, softgels, effervescent tablets in tubes, drink cubes, powder sachets of 4 to 12 g, drops, syrups, shots and sports nutrition powders. All are made in Mārupe, Latvia, on four production lines for tablets and capsules, powders, effervescent products and liquid forms.
What is the minimum order for nutraceutical manufacturing?
At Pharma Manufacture a ready-made tablet or capsule formula starts from 150 units and powder sachets from 80,000. For effervescent tablets, softgels, liquids, drink cubes and sports powders the pack and the formula set the minimum, quoted within 24 hours. Your own formula starts higher than a ready-made one.
How long does a nutraceutical order take?
From 4 weeks, and about 8 weeks for a typical run, counted from the moment Pharma Manufacture has your confirmed order and technical brief. Powder sachets take about 8 weeks, because the laminate with your design is printed first. A custom formula adds development and a validation batch.
What certificates does Pharma Manufacture hold?
GMP-FS-01 and HACCP-01, valid to 17 May 2027, and ISO 22000:2018 MSC-22-1384, valid to 7 January 2029, issued by BM Certification SIA in Riga. Scans with numbers and dates are on the certificates page.
Who registers or notifies the product in my country?
The brand or its local importer, as the business placing the product on the market. Where a member state requires a notification under Article 10 of Directive 2002/46/EC, it is filed with a model of the label. Pharma Manufacture supplies the Certificate of Analysis and the certificate copies for that file.
Can I audit the factory before ordering?
Yes. Pharma Manufacture is audited every year by customers and by government bodies, and the certification body re-audits the GMP and HACCP certificates every year; the ISO 22000 certificate runs to 7 January 2029. A buyer audit is arranged through the sales team at sales@pharmamanufacture.eu.
Send the form, the formula and the market
Pharma Manufacture makes nutraceuticals as food supplements in Mārupe, Latvia, two minutes from Riga International Airport, and holds GMP, ISO 22000 and HACCP certificates. Name the form, a catalogue formula or your own, the pack and the country of sale, and the reply comes within 24 hours with a price list and the lead time. The full range is on our products, and if you are comparing factories, these nine questions help. Request a price list.
Sources
Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, Articles 1, 2, 4(1), 5, 6 and 10, text as adopted (Official Journal L 183, 12.7.2002); later amendments exist and were not read, so this is not the consolidated text: https://www.legislation.gov.uk/eudr/2002/46/contents/adopted (PDF read 2026-11-02)
Directive 2002/46/EC on food supplements, status in force checked 30 October 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32002L0046
Regulation (EU) No 1169/2011 on the provision of food information to consumers, status in force checked 30 October 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32011R1169
Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, status in force checked 30 October 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R1924
Regulation (EU) No 432/2012, list of permitted health claims, status in force checked 30 October 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R0432
Regulation (EC) No 852/2004 on the hygiene of foodstuffs, status in force checked 30 October 2026: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004R0852
Pharma Manufacture, manufacturing: factory, staff, production lines, certificates with dates and issuing body, quality control, traceability, R&D, audits: https://pharmamanufacture.eu/private-label-food-supplement-manufacturer-uk/ (page source of 2026-10-30)
Pharma Manufacture, our products: forms, minimum order and lead time by form: https://pharmamanufacture.eu/our-products/ (page source of 2026-10-30)
Pharma Manufacture, tablets, capsules and softgels; equipment; effervescent tablets; powder sachets; liquid forms; drink cubes; sports nutrition: https://pharmamanufacture.eu/food-supplement-tablets-and-capsules/ and https://pharmamanufacture.eu/equipment/ (page sources of 2026-10-30)
Pharma Manufacture, buyer questions: documents and Certificate of Analysis, lead time, your own formula, samples, failed batches, notification in your country: https://pharmamanufacture.eu/buyer-questions/ (page sources of 2026-10-30)
