Biotin Softgel Manufacturer for Global Brands

Our Guangdong plant runs 12 softgel filling lines with a combined capacity of 500,000 softgels per day. We use rotary die encapsulation for consistent fill weights from 250 mg to 1,500 mg. Biotin is suspended in fractionated coconut oil or MCT oil, then filled into gelatin or vegan shells. Inline checks monitor shell thickness, seam integrity, and fill accuracy every 30 minutes.

For biotin softgels, we offer oval, oblong, and round shapes in sizes 5 to 20. Drying tunnels control temperature and humidity to prevent sticking or leakage. We can add enteric coating for delayed release or a matte finish for premium retail. Packaging options include HDPE bottles, blister packs, and sachets, with labelling in English, Arabic, or EU languages.

Biotin is available as D-biotin, the biologically active form. Typical doses range from 1,000 mcg for daily maintenance to 10,000 mcg for high-potency formulas. We can combine biotin with other oil-soluble actives such as vitamin D3, vitamin E, or omega-3. For water-soluble ingredients, we use suspension technology to keep them evenly distributed in the oil base.

Shell options include bovine gelatin, fish gelatin, and vegan HPMC. For halal certification, we source gelatin from certified suppliers and maintain full traceability. We also offer organic biotin softgels using certified oil and shells. Flavour masking is available for unflavoured or mildly flavoured softgels. All raw materials arrive with certificates of analysis and are quarantined until QC release.

The facility is GMP-certified and holds ISO 22000 and HACCP. We are FDA-registered for dietary supplements. Each batch of biotin softgels is tested for potency, fill weight, disintegration, and microbial limits. Heavy metals and residual solvents are tested per USP methods. We retain samples for 24 months and provide a certificate of analysis with every shipment.

For international orders, we handle export documentation, including certificate of origin, health certificates, and halal certificates. Shipping is available FOB Shenzhen or Yantian, or CIF to major ports. Air freight takes 5–10 days to the US or EU; sea freight takes 25–35 days. We support private label and white label packaging with your artwork.

Every biotin softgel batch is tested at three points: incoming raw material, in-process fill weight, and finished product. Identity and potency of biotin are confirmed by HPLC against a reference standard, with acceptance at 90.0–110.0% of label claim. Microbial testing covers total aerobic count, yeast and mould, E. coli, and Salmonella, with limits set to USP <2021> and <2022>. Heavy metals (lead, arsenic, cadmium, mercury) are screened by ICP-MS to USP <232> limits. Disintegration testing follows USP <2040>, with a typical result of 12–18 minutes for a 500 mg gelatin softgel.

A Certificate of Analysis (COA) is issued for each batch and includes lot number, manufacturing date, expiry date, biotin content, fill weight average and range, microbial results, heavy metals, disintegration time, appearance, and a statement of conformity to the agreed specification. We retain a sealed sample of every batch for the full shelf life plus six months. Stability is monitored on the first three commercial batches at 25°C/60% RH and 40°C/75% RH, with testing at 0, 3, 6, 12, 18, and 24 months. Accelerated data supports a 24-month shelf life declaration; real-time data is added to the file as it accumulates.

Batch records are retained for five years and are available for review during customer or third-party audits. If you need a specific microbial limit, a narrower potency range, or a custom disintegration specification, these are written into the master batch record before the first production run. We do not release a batch until the QC manager signs the COA and the retention sample is logged. For brands selling on Amazon or entering the EU, the COA and batch record package is the primary document set requested by retailers and importers.

Biotin softgels can be packed in HDPE bottles (60, 90, 120, 180, or 250 count), blister packs (10, 30, or 60 count), or single-serve sachets. Bottles use induction seals, child-resistant caps where required, and a desiccant canister for humidity control. Labelling follows the US FDA dietary supplement format: statement of identity, net quantity, supplement facts panel with biotin mcg and %DV, other ingredients, directions, warnings, and manufacturer/distributor contact. We print lot number and expiry date on the bottle, carton, and shipper in a single pass, with a minimum 24-month expiry at pack-out.

Cartons are specified to your retail requirements: typical dimensions are 65 x 65 x 110 mm for a 90-count bottle, with 24 bottles per shipper and 48 shippers per pallet (1,152 bottles). Pallet footprints are 1,200 x 1,000 mm or 1,200 x 800 mm to suit EU and US warehouse systems. For Amazon FNSKU compliance, we apply the FNSKU label over the barcode, poly-bag the unit if required, and print the expiration date in the Amazon-specified format. We can also supply the product in unbranded white-label bottles if you handle labelling in your own market.

Artwork proofing is a formal step: you supply the label file, we return a PDF proof with dieline, barcode placement, and text legibility check. We do not print until you sign off. If you need a US agent or EU responsible person statement on the label, we can include the address block you provide. For retail chains that require a GS1 barcode, we verify the barcode with a scanner before the run. Packaging materials are food-grade and meet EU 10/2011 and US 21 CFR 177 requirements for direct food contact.

The sample timeline starts with a 7–10 working day turnaround for a pilot batch of 1,000 softgels. You receive the sample with a draft COA and a packaging mock-up. Once you approve the sample and sign the artwork proof, mass production runs 20–35 working days, depending on bottle count and whether blister or sachet packing is required. The MOQ is 1,000 units per SKU for retail bottling. For a first order, we can split the MOQ across two fill strengths, for example 1,000 mcg and 5,000 mcg, provided the total volume meets the line minimum.

Shipping is arranged by air or sea. Air freight from Guangdong to the US or EU typically takes 5–8 days door-to-door for 200–500 kg; sea freight takes 25–35 days port-to-port. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for most destinations. DDP includes customs clearance and duty, which simplifies the first order for new brands. For repeat orders, FOB is usually more cost-effective. We provide a packing list, commercial invoice, and bill of lading or airway bill with every shipment.

The document pack includes the COA, MSDS, free-sale certificate, and, where relevant, phytosanitary certificate for botanical components. For EU customers, we provide the statement of compliance for food-contact materials and the manufacturing site's GMP certificate. If your customs broker needs a specific declaration, send the template before booking and we will complete it. We do not release goods until the balance payment clears and the shipping documents are checked against the order.