Vitamin B12 Tablet Manufacturer for Your Brand

Our Guangdong plant runs two rotary tablet presses dedicated to vitamin tablets, with a combined capacity of 120 million tablets per month. For B12, we use direct compression or wet granulation depending on dosage and excipient profile. Low-dose B12 (0.5–100 mcg) requires precise blend uniformity, so we use a 500-litre V-blender with a 1:10,000 dilution step and in-process sampling every 15 minutes. High-dose tablets (500–5,000 mcg) are compressed on a 35-station press at 30–60 tablets per minute. Tooling is available in round, oval, and caplet shapes from 6 mm to 13 mm. We can run film coating, sugar coating, or uncoated tablets. Packaging options include HDPE bottles, blister packs, and stick packs. Bottle filling lines handle 30, 60, 90, 120, and 180 counts.

Changeover between B12 and other vitamin products follows a validated cleaning protocol with swab testing for cross-contamination. The plant operates 22 hours per day, 6 days per week. For orders above 500,000 tablets, we can dedicate a press to your SKU for the full production window. Lead time for mass production is 20–35 working days after sample approval, depending on coating and packaging requirements. We provide a production schedule within 48 hours of order confirmation.

Vitamin B12 is available in several forms: cyanocobalamin, methylcobalamin, adenosylcobalamin, and hydroxocobalamin. Cyanocobalamin is the most stable and cost-effective for tablets, with a typical overage of 10–20% to meet label claims through 24-month shelf life. Methylcobalamin is less stable under light and heat; we recommend film coating and opaque packaging to maintain potency. We can combine B12 with other B vitamins, folic acid, iron, or intrinsic factor. Excipient selection matters: microcrystalline cellulose and dicalcium phosphate are common diluents, while magnesium stearate and silicon dioxide improve flow. For vegan claims, we use plant-based magnesium stearate and avoid gelatin. Sugar-free options use sorbitol or xylitol. We can also produce sublingual tablets that dissolve under the tongue in 30–60 seconds.

Flavour systems include mint, cherry, and unflavoured. We test compatibility between B12 and any active or excipient using accelerated stability studies at 40°C/75% RH for 3 months. If you have an existing formula, we can match it or suggest adjustments for better compression or stability. All formulations are documented with a master batch record and bill of materials. We do not use titanium dioxide or any EU-banned colours. For organic certification, the B12 must come from a certified organic source, and we audit suppliers accordingly.

Every batch of B12 tablets is tested for potency, uniformity of dosage units, disintegration, and microbial limits. We use HPLC for B12 quantification and USP <711> for dissolution. The facility is GMP-certified, ISO 22000, and HACCP-compliant. We are FDA-registered for dietary supplements. Certifications for halal and vegan are maintained through annual audits. Heavy metals testing (lead, cadmium, arsenic, mercury) is performed on every incoming raw material lot and finished product. We retain samples for 2 years after production. Certificates of analysis are issued per batch and include all test results. For US customers, we provide a letter of guarantee and can support FDA prior notice filing. For EU customers, we provide documentation for novel food and health claim compliance where applicable.

We also offer third-party testing through SGS or Eurofins at your request. Stability protocols follow ICH guidelines: 25°C/60% RH for 24 months, with 6-month accelerated data. If a batch fails any specification, we investigate root cause and either rework or reject. Our quality team has 12 staff, including 3 chemists. We maintain a deviation log and CAPA system. For logistics, we ship FOB Shenzhen or Yantian, with air freight for urgent orders. Typical sea freight to US West Coast is 18–22 days; to EU ports, 25–30 days. We handle export documentation, including certificate of origin and health certificate.

Every batch of Vitamin B12 tablets is sampled at three points: incoming raw material, in-process compression, and finished goods. Identity testing on cyanocobalamin and methylcobalamin uses HPLC against a certified reference standard. Potency is assayed by HPLC with acceptance at 95.0–105.0% of label claim at release. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella. Heavy metals (lead, arsenic, cadmium, mercury) are tested by ICP-MS against ICH Q3D limits. Disintegration testing follows USP <701> with a 15-minute limit for uncoated tablets and 30 minutes for film-coated.

Batch records are compiled during production and reviewed by QA before release. The Certificate of Analysis (COA) issued with each lot includes product name, batch number, manufacture and expiry dates, tablet weight, hardness, disintegration time, potency result, microbial results, heavy metals results and a statement of conformity. If you require additional tests such as dissolution profiling or residual solvents, these can be added to the specification and reported on the COA. Retention samples of each batch are held for the full shelf life plus six months under controlled conditions at 25°C/60% RH.

Stability protocols follow ICH Q1A(R2). Accelerated testing runs for six months at 40°C/75% RH with testing at 0, 1, 2, 3 and 6 months. Long-term testing runs at 25°C/60% RH for the proposed shelf life, typically 24 months, with testing every three months in the first year and every six months thereafter. Results are documented in a stability report that supports the expiry date printed on your label. For methylcobalamin, which is light-sensitive, we recommend amber bottles or opaque blister foil and include photostability data in the stability package.

Deviation and out-of-specification (OOS) investigations are documented under written SOPs. If a batch fails potency or disintegration, an OOS report is opened, root cause investigated and corrective action recorded before any re-test or re-work decision. You receive a copy of the OOS report if it affects your order. Annual product quality reviews summarise batch trends and are available on request for brand owners who need supplier qualification documentation.

Vitamin B12 tablets can be packed in HDPE bottles with induction seals and child-resistant or standard caps, in blister packs using PVC/PVDC or alu-alu foil, in stick packs, or in sachets. Bottle sizes range from 30 cc to 500 cc, with counts from 30 to 500 tablets. Blister cards are available in 10, 14, 21 or 30-tablet formats. For methylcobalamin, alu-alu blister or amber HDPE is recommended to limit light exposure. We can apply desiccant canisters or silica gel sachets where humidity sensitivity requires it.

Labels are printed to your artwork and must include the FDA dietary-supplement label elements if the product is sold in the United States: statement of identity, net quantity of contents, supplement facts panel, list of ingredients, allergen statement where applicable, and the name and place of business of the manufacturer, packer or distributor. Lot number and expiry date are inkjet-coded on the bottle or carton, and we can add a best-by date format to suit your market. For Amazon FNSKU labelling, we apply the FNSKU barcode over the existing barcode or on a separate label as specified. Retail compliance checks include barcode scannability (UPC-A or EAN-13) and carton marking.

Cartons are specified to your dimensions with a 3-ply or 5-ply corrugated board. Standard export cartons hold 12, 24 or 48 bottles, with a maximum gross weight of 15 kg for manual handling. Palletisation is 1,200 x 1,000 mm or 1,200 x 800 mm, stretch-wrapped and corner-protected, with a maximum height of 1,800 mm including pallet. We can print lot number, expiry date, carton count and country of origin on each carton. For retail-ready packaging, shelf-ready trays and display cartons can be quoted separately.

Sample lead time is 7–10 working days from receipt of your formulation brief and artwork for standard stock bottles. Custom blister or stick-pack samples add 5–7 working days. Mass production runs 20–35 working days after sample approval and receipt of a deposit. The production window includes tablet compression, coating where required, packaging, in-process testing and QA release. Peak season (August to November) can extend lead times by 5–10 working days, so early booking is advised.

Shipments are arranged by air or sea. Air freight from Guangdong to the US or EU typically takes 5–8 days door to door, while sea freight takes 25–35 days port to port. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for most destinations. DDP pricing includes freight, insurance, customs clearance and duties, and is available for the US, EU, UK, Canada and Australia. For FOB shipments, we provide the booking confirmation, packing list and commercial invoice within three working days of vessel departure.

Documents provided with each shipment include the Certificate of Analysis, Material Safety Data Sheet (MSDS) where applicable, free-sale certificate, and phytosanitary certificate for plant-derived excipients where the destination country requires it. A certificate of origin can be issued on request. For EU deliveries, we provide the necessary statements for the food supplement directive, including allergen and novel food status where relevant. All documents are issued in English and can be legalised or apostilled if your market requires it.