Iron Tablet Manufacturer for Your Brand

Iron Tablet Manufacturer for Your Brand

EUPHM produces iron tablets in a GMP-certified facility in Guangdong, China. We handle formulation, blending, compression, coating, and packaging for brands in the US, EU, UK, and Middle East. MOQ starts at 1,000 units per SKU.

Iron Tablet Manufacturer for Your Brand

Overview

Sourcing iron tablets requires a manufacturer that understands both dosage precision and regulatory demands. Our plant runs dedicated compression suites for iron-based products, with fill weights from 100 mg to 1,200 mg. We support ferrous fumarate, ferrous sulfate, ferrous bisglycinate, and carbonyl iron. Every batch is tested for potency, dissolution, and heavy metals before release. Lead times run 20-35 working days for mass production after sample approval. Certifications include GMP, ISO 22000, HACCP, plus halal, and where applicable.

Key specifications
MOQ1,000 units per SKU
Fill weight range100 mg to 1,200 mg per tablet
Sample lead time7-10 working days
Mass production lead time20-35 working days after sample approval
CertificationsGMP, ISO 9001, ISO 22000, HACCP, NSF/ANSI 455-2, halal, FDA-registered
Monthly tablet capacityUp to 120 million tablets across compression lines

Iron Tablet Manufacturing Capability

Our compression suite includes 12 rotary tablet presses with force feeders and automatic weight control. We run dedicated tooling for iron blends to prevent cross-contamination with non-iron products. Typical output is 180,000 to 400,000 tablets per shift, depending on tablet size and coating requirements. We offer film coating, sugar coating, and enteric coating for delayed release. In-process checks every 15 minutes monitor weight variation, hardness, and thickness. Batch records are retained for five years and available for audit.

We handle a range of iron salts and complexes. Ferrous fumarate at 200 mg elemental iron, ferrous sulfate at 65 mg, ferrous bisglycinate at 25 mg, and carbonyl iron at 45 mg are common. Tablets can be immediate-release, sustained-release, or enteric-coated. We also produce chewable and effervescent formats. Tooling changes take 2-4 hours. Changeover cleaning follows a validated protocol with swab testing for iron residue. This keeps your product compliant with EU and US contaminant limits.

Formulation and Ingredient Options

Iron tablets often combine iron with vitamin C, B12, folate, or copper to improve absorption or reduce side effects. We can source these actives from approved suppliers with full traceability. Vitamin C at 40-120 mg per tablet is common for enhanced uptake. We also offer sustained-release matrices using hypromellose or ethylcellulose. For sensitive stomachs, we can formulate with ferrous bisglycinate, which is gentler than ferrous sulfate. Flavour systems for chewables include berry, citrus, and mint. All excipients are non-GMO and allergen-controlled.

We work with you on taste, mouthfeel, and disintegration time. Immediate-release tablets typically disintegrate within 15 minutes. Enteric-coated tablets resist stomach acid for 2 hours. We can adjust hardness from 6 to 12 kp to match your packaging and shipping needs. Colourants can be natural or synthetic, including iron oxide pigments. We provide formulation sheets with full ingredient breakdowns, overage calculations, and suggested dosage. Our R&D team can develop a prototype in 5-7 working days from your target profile.

Quality Control and Regulatory Compliance

Every batch of iron tablets is tested for assay, uniformity of dosage units, dissolution, and moisture. We use HPLC, ICP-MS, and UV-Vis spectroscopy. Heavy metal testing covers lead, cadmium, arsenic, and mercury at limits below 1 ppm. Microbial testing includes total aerobic count, yeast, mould, E. coli, and Salmonella. We release only after all specifications pass. Certificates of analysis are issued per batch. Our facility is FDA-registered and GMP-certified. We also hold ISO 22000 and HACCP certification.

For market entry, we provide documentation for US, EU, UK, and Middle East submissions. This includes technical files, stability data, and free sale certificates. We can arrange halal certification for your SKU. Labelling support covers FDA, EFSA, and GCC health claims. We do not claim FDA approval. Our team helps with product registration timelines. Shipping is available FOB Shenzhen or CIF to major ports. MOQ is 1,000 units for retail bottling for market testing.

Iron Tablet Quality Control and Batch Documentation

Every iron tablet batch is sampled at three points: incoming raw material, in-process compression, and finished goods. Raw material identity is confirmed by FTIR against a reference standard, and potency is assayed by ICP-OES or titration depending on the iron salt. Microbial testing covers total aerobic count, yeast and mould, E. coli, and Salmonella, with limits set to USP <2021> and <2022>. Heavy metals are screened for lead, arsenic, cadmium, and mercury to EU and US pharmacopoeial limits. Disintegration testing follows USP <701> at 37°C in purified water, with iron tablets typically required to disintegrate within 30 minutes.

In-process checks run every 30 minutes during compression: weight variation within ±5% of target, hardness within a defined range for the chosen tooling, and friability below 1.0% after 100 drops. These records are retained in the batch manufacturing record, which is reviewed by QA before release. Finished tablets are tested for potency, uniformity of dosage units, dissolution where applicable, and moisture content. A certificate of analysis (COA) is issued per batch and includes the batch number, manufacturing date, expiry date, test parameters, specifications, results, and the analyst and QA signatories.

Retention samples are kept for the shelf life plus 12 months, stored under labelled conditions at 25°C/60% RH and 30°C/65% RH for stability studies. The stability protocol covers 0, 3, 6, 12, 18, and 24 months, with accelerated conditions at 40°C/75% RH for 6 months. Iron tablets are prone to oxidation and moisture uptake, so packaging compatibility is assessed alongside the stability programme. If a customer requires a shorter lead time, a 6-month accelerated study can support a 24-month shelf life claim, subject to the regulatory pathway in the destination market.

Documentation packages are prepared in English as standard, with translated labels and COAs available for EU, Middle East, and Southeast Asian markets. Batch records, deviation reports, and change controls are retained for five years and are available for audit. Customers can request a batch-specific COA before shipment, and a representative sample from the same batch can be couriered for third-party verification. This level of traceability is what retail buyers and importers need when they place iron tablet orders under their own brand.

Packaging, Labelling and Retail Readiness

Iron tablets can be packed in HDPE bottles from 30 cc to 500 cc, blister packs in PVC/PVDC or alu-alu, stick packs, and sachets. Bottle fills range from 30 to 300 tablets, with induction seals and child-resistant closures available. Blister formats suit pharmacy and travel retail, while stick packs and sachets work for single-dose iron supplements. Desiccant canisters or silica gel sachets are added where the formulation is moisture-sensitive. Cartons are printed on 300-350 gsm board with lot number and expiry date inkjet-coded or laser-etched on the base.

For the US market, labels must include the statement of identity, net quantity, supplement facts panel with iron content as a percentage of daily value, other ingredients, directions, warnings, and the manufacturer or distributor name and address. The FDA does not pre-approve labels, but the supplement facts format and nutrient units must follow 21 CFR 101.36. For the EU, Regulation (EU) No 1169/2011 and the Food Supplements Directive apply, with iron content declared per portion and a warning not to exceed the stated dose. We prepare print-ready artwork for customer approval and retain a signed proof before printing.

Lot and expiry coding is applied to each primary unit, carton, and shipper. Cartons are packed in corrugated shippers with a maximum of 12 bottles per shipper for 100 cc bottles, and pallets are configured to 1,200 x 1,000 mm or 1,200 x 800 mm depending on the destination. Shrink wrap and corner boards protect the load for sea freight. For Amazon sellers, we can apply FNSKU labels and poly-bag units where required, and we can pack to Amazon's carton weight and dimension limits. Retail compliance checks cover barcode scannability, country of origin marking, and allergen statements where applicable.

Artwork review typically takes 3-5 working days, and packaging materials add 7-10 working days to the production schedule if they are new to us. Existing bottle and closure tooling can reduce this to 3-5 working days. We do not print claims that are not supported by the formulation or the agreed certificate of analysis. If a customer requires organic or halal logos, the relevant certificate number must be supplied and verified before the artwork is released for print.

Iron Tablet MOQ, Lead Times and Delivery Terms

Sampling starts with a formulation brief and a target dose. Prototype tablets are produced within 7-10 working days, and the sample is couriered for customer review. If the sample requires adjustment, a second round adds 5-7 working days. Once the sample is approved in writing, mass production is scheduled for 20-35 working days, depending on packaging complexity and whether the iron salt is in stock. Pilot runs from 1,000 units are available for market testing, while standard MOQ is 1,000 units per SKU. Monthly capacity is up to 120 million tablets across compression lines.

Air freight is typically 5-8 working days door to door for 100-300 kg shipments, while sea freight runs 25-40 days depending on the destination port. For urgent retail launches, air freight is cost-effective for smaller volumes, while sea freight suits full pallet orders. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for selected markets. DDP pricing includes duties and delivery to the customer's warehouse, but it requires a confirmed HS code and a valid import entity in the destination country. We do not arrange customs clearance without the correct importer of record.

Shipping documents include the commercial invoice, packing list, bill of lading or airway bill, certificate of analysis, material safety data sheet (MSDS), and a free-sale certificate where required by the destination authority. For plant-based or organic lines, a phytosanitary certificate or organic transaction certificate can be provided if the raw material supplier has issued the underlying documentation. Certificates of origin can be issued for preferential tariff treatment under applicable trade agreements. Documents are sent electronically before shipment and in hard copy with the cargo where required.

Payment terms are typically 30% deposit with the balance against the bill of lading copy, and we accept T/T and irrevocable L/C at sight for larger orders. Production slots are confirmed only after the deposit is received and artwork is approved. If a customer needs to split shipments across multiple SKUs, we can consolidate cartons on a single pallet to reduce freight cost. Delivery performance is tracked per order, and any delay beyond the agreed window is communicated with a revised schedule and a root-cause summary.

Formats and Packaging Options

Immediate-release tablets

Standard compression for rapid disintegration. Suitable for ferrous sulfate and fumarate. Fill weights 100-800 mg. Hardness 6-10 kp. Typical disintegration under 15 minutes.

Sustained-release tablets

Matrix or coated systems for gradual iron release. Reduces peak dose side effects. Fill weights 300-1,200 mg. Release profile over 4-8 hours. Common for ferrous bisglycinate.

Enteric-coated tablets

Acid-resistant coating for release in the intestine. Reduces stomach irritation. Fill weights 200-900 mg. Coating weight gain 2-5%. Disintegration after 2 hours in acid.

Chewable and effervescent

Flavoured chewables or effervescent tablets for paediatric or adult use. Fill weights 150-1,000 mg. Sugar-free and natural flavour options. Packed in tubes or blister packs.

From Brief to Batch

  1. 01

    Inquiry and specification

    Share your target formula, fill weight, coating, and packaging. We review feasibility and send a quotation within 2 working days.

  2. 02

    Sample development

    Our R&D team prepares a prototype. You receive samples in 7-10 working days. We adjust until you approve the formulation and sensory profile.

  3. 03

    Quotation and contract

    We finalise pricing, MOQ, lead time, and payment terms. A manufacturing agreement is signed. You provide purchase order and artwork.

  4. 04

    Raw material sourcing

    We order iron actives and excipients from approved suppliers. All materials arrive with certificates of analysis. Quarantine and sampling occur on receipt.

  5. 05

    Production and QC

    Blending, compression, coating, and packaging run on dedicated lines. In-process controls every 15 minutes. Finished tablets tested for assay, dissolution, and microbes.

  6. 06

    Release and shipping

    Batch records and certificates of analysis are issued. We pack and ship FOB Shenzhen or CIF. Lead time 20-35 working days after sample approval.

Why EUPHM

Dedicated iron lines

Separate compression suites and tooling prevent cross-contamination. Validated cleaning with swab testing for iron residue. Meets EU and US contaminant limits.

Flexible MOQ and pilot runs

Start with 1,000 units for market testing. Scale to 1,000 units per SKU for retail. Volume discounts from 10,000 units.

Full certification support

GMP, ISO 9001, ISO 22000, HACCP, NSF/ANSI 455-2 and halal certification; FDA facility registration for US-bound shipments.

Questions buyers ask.

What is the MOQ for iron tablets?+

MOQ is 1,000 units per SKU for retail bottling. Pilot runs start at 1,000 units for market testing. For effervescent or chewable formats, MOQ may be 5,000 units due to tooling and packaging setup.

How long does production take?+

Sample lead time is 7-10 working days. Mass production runs 20-35 working days after sample approval and receipt of purchase order. Shipping time depends on destination. We ship FOB Shenzhen or CIF to major ports.

Can you formulate with ferrous bisglycinate?+

Yes. We produce tablets with ferrous bisglycinate at 25 mg elemental iron, as well as ferrous fumarate, ferrous sulfate, and carbonyl iron. We can combine with vitamin C, B12, folate, or copper for absorption or tolerance.

What certifications do you hold?+

Our facility is GMP-certified, ISO 22000, and HACCP. We also arrange halal, and vegan certification for your SKU. We are FDA-registered. We do not claim FDA approval.

Do you provide certificates of analysis?+

Yes. Every batch is tested for assay, uniformity, dissolution, moisture, heavy metals, and microbes. A certificate of analysis is issued per batch. Batch records are retained for five years and available for audit.

What iron forms can you compress into tablets, and do you offer chelated iron?+

We compress ferrous fumarate, ferrous sulfate, ferrous bisglycinate, and carbonyl iron. Ferrous bisglycinate is a chelated form and is available for gentle-on-the-stomach positioning. Carbonyl iron is used where a lower elemental iron content per tablet is required. We can combine iron with vitamin C, folic acid, or B12 in the same tablet, subject to compatibility and stability testing. The choice of salt affects tablet weight, colour, and dissolution, so we confirm the form during sampling.

Can you provide a COA and stability data before I place a bulk order?+

Yes. A representative COA from a recent batch of the same formulation can be shared during sampling, and a batch-specific COA is issued after production. Stability data from ongoing studies at 25°C/60% RH and 30°C/65% RH can be provided for the agreed shelf life, with accelerated data at 40°C/75% RH for 6 months. If your market requires a specific shelf life claim, we review the available data and advise whether a new stability study is needed before labelling.

Do you handle labelling artwork and Amazon FNSKU requirements?+

We prepare print-ready artwork based on your label content and review it against US or EU labelling rules before printing. For Amazon sellers, we can apply FNSKU labels, poly-bag units, and pack to Amazon carton weight and dimension limits. We retain a signed proof before print. We do not create claims or supplement facts values without your approval, and we do not print certification logos unless the certificate number is supplied and verified. Artwork review typically takes 3-5 working days.

Have a product in mind?

Send us the brief and we will come back with a formulation direction, indicative price and a realistic lead time — usually within one working day.