Biotin Tablet Manufacturer for Global Supplement Brands

Our rotary tablet presses run biotin at 500,000 tablets per day on a single shift. We maintain tooling for 6 mm to 12 mm round, oval, and caplet shapes. For biotin, common configurations include 8 mm round, 9 mm oval, and 10 mm caplet. Compression force is adjusted per batch to achieve a hardness of 8–12 kp, which balances dissolution and shipping durability.

We run pilot batches from 500 tablets for R&D, then scale to commercial runs. Changeover between biotin SKUs takes 2–4 hours, including full cleaning of the press, hopper, and deduster. For brands launching multiple dosages, we schedule sequential runs to reduce downtime. All tooling is inspected for wear every 50,000 tablets.

Biotin is a low-dose active, typically 0.1–1% of tablet weight. That makes blend uniformity critical. We use a 500 L V-blender with a 15-minute pre-blend for biotin and excipients, followed by a 20-minute final blend. Uniformity is verified by sampling 10 locations; acceptance criteria are 90–110% of label claim with RSD ≤ 5%.

We can combine biotin with zinc, selenium, collagen, silica, or vitamin C. For clean-label SKUs, we use microcrystalline cellulose, dicalcium phosphate, and vegetable magnesium stearate. Coating options include film, enteric, and colour. We do not use titanium dioxide unless required by the destination market. All actives are tested for identity and potency before release to production. Typical excipient load is 30–50% of tablet weight.

Every biotin batch is tested for assay, uniformity, disintegration, and hardness. We retain samples for 24 months. The facility is GMP-certified, ISO 22000, and HACCP. For halal and we source certified excipients and maintain separate production slots. and vegan claims are supported by supplier declarations and finished-product testing where required.

For US, EU, UK, and Middle East markets, we provide documentation: certificate of analysis, MSDS, allergen statement, and GMO-free declaration. Our team can review label claims for compliance with FDA 21 CFR 111, EU Directive 2002/46/EC, and GCC standards. We do not claim FDA approval; our facility is FDA-registered. Shipping is coordinated from Shenzhen or Hong Kong, with air and sea options.

Every biotin tablet batch undergoes a defined QC schedule. Incoming biotin raw material is tested for identity by FTIR and assay by HPLC before release to production. During compression, in-process checks every 30 minutes monitor tablet weight, hardness, thickness, and friability. After coating (where applicable), finished tablets are sampled for potency, microbial limits (total aerobic count, yeast and mould, E. coli, Salmonella), heavy metals (lead, arsenic, cadmium, mercury), and disintegration time. These tests follow USP or EP methods as agreed, and results are recorded against the batch record.

A certificate of analysis (COA) is issued for each batch and includes the product name, batch number, manufacturing date, expiry date, specification limits, test methods, and actual results. The COA also states the dosage of biotin per tablet and confirms compliance with the agreed specification. Where a customer requires it, we include additional tests such as zinc or collagen assay for combination products. Retention samples of each batch are stored under controlled conditions for the shelf life plus 12 months, allowing re-testing if a market query arises.

Stability testing follows a standard protocol: accelerated conditions at 40°C/75% RH for six months and real-time conditions at 25°C/60% RH for the declared shelf life. We test appearance, potency, disintegration, and microbial limits at 0, 3, 6, 12, 24, and 36 months as applicable. For biotin tablets, potency loss is typically minimal, but we verify that the tablet matrix protects the active through the declared period. Stability data packages are available to support your regulatory submission, and we can customise the protocol to meet destination-country requirements.

Biotin tablets can be packed in HDPE bottles with induction seals and child-resistant or standard caps, in blister packs (PVC/PVDC or alu-alu), in stick packs, or in single-serve sachets. Bottle sizes range from 30 to 500 counts, with desiccant options for humidity protection. Blister packs are available in 10, 14, or 21 tablet formats. For stick and sachet formats, we fill 2 to 5 grams per unit, suitable for powder blends or coated tablets. Labelling follows FDA dietary supplement requirements: statement of identity, net quantity, supplement facts panel, ingredient list, allergen statement, and manufacturer/distributor information.

Lot and expiry coding is applied by inkjet or laser on the bottle, blister, or carton, with formats matching your market. We maintain coding records for traceability. Carton specifications are agreed per order: typical dimensions, corrugated board grade, and pallet configuration. Standard pallets are 1,200 x 1,000 mm or 1,200 x 800 mm, with stretch wrapping and corner boards. For Amazon FNSKU labelling, we can apply labels and poly-bag units as required, and we follow retail compliance guidelines for Walmart and other chains, including carton marking and SSCC labels where specified.

Retail-ready packaging includes tamper-evident seals, lot-specific expiry dates, and barcodes (UPC or EAN) verified by scanner before dispatch. We can also provide digital assets such as label proofs and dielines for your design team. For markets requiring bilingual labels or specific regulatory statements, we review the artwork against destination requirements and flag any missing elements before printing. Packaging materials are food-grade and meet EU and US contact regulations, and we can supply migration test reports on request.

The sampling timeline for biotin tablets is 7 to 10 working days after receipt of a signed sample request and specification. This includes raw material testing, pilot blending, compression, and QC release of the sample batch. Sample quantities are typically 100 to 300 tablets, depending on dosage and size. Once you approve the sample and confirm packaging artwork, mass production begins. The standard production window is 20 to 35 working days, depending on order volume, packaging complexity, and whether custom tooling is required. We provide a production schedule with milestones at order confirmation.

For delivery, we offer EXW, FOB, and DDP terms. FOB shipments typically depart from Shenzhen or Hong Kong ports. Air freight is available for urgent orders, with transit times of 3 to 7 days to major hubs, while sea freight takes 20 to 35 days depending on destination. We coordinate with your freight forwarder or arrange shipping through our partners. For DDP, we handle customs clearance and delivery to your door, with duties and taxes included in the quoted price. All shipments are palletised and shrink-wrapped, and we provide packing lists and commercial invoices.

Documentation provided with each shipment includes the certificate of analysis, material safety data sheet (MSDS) where applicable, free-sale certificate, and phytosanitary certificate for plant-derived ingredients if required by the destination country. We also supply a certificate of origin and, for organic products, the organic transaction certificate. Additional documents such as halal certificates are included when the order is produced under those certifications. We retain copies of all shipping documents for two years and can provide replacements if needed.