Vitamin B12 Oral Spray Manufacturer for Global Brands

Our Guangdong plant runs two dedicated oral spray lines. Each line fills 8,000-12,000 bottles per shift, depending on bottle size and pump type. We handle 15 ml, 20 ml and 30 ml PET or glass bottles with crimp-on or screw-on pump actuators. Changeover between SKUs takes 4-6 hours, including cleaning and line clearance. For pilot runs, we use a semi-automatic line that fills from 1,000 units, so you can test the market before committing to full-scale production.

Every batch passes through an in-line checkweigher and a vision system that inspects fill volume and pump placement. We hold a 2-3% overfill allowance to meet label claims at end of shelf life. The facility is FDA-registered and operates under GMP, ISO 22000 and HACCP. If your formula needs a specific spray angle or fine mist, we can source custom actuators with 3-6 week tooling lead time.

Vitamin B12 is available in four common forms: methylcobalamin, cyanocobalamin, adenosylcobalamin and hydroxycobalamin. Methylcobalamin is the most requested for oral sprays because it is the active coenzyme form. We can formulate at 500 mcg, 1,000 mcg or 1,500 mcg per actuation. The base is typically purified water, glycerin, natural flavouring and a preservative system. For vegan and halal claims, we use plant-derived glycerin and avoid animal-derived excipients.

Our formulation team can adjust sweetness, pH and viscosity to match your target sensory profile. We run stability studies at 25°C/60% RH and 40°C/75% RH for 3-6 months to confirm potency and spray performance. If you have an existing formula, we can replicate it under a confidentiality agreement. If you need a new one, we provide 2-3 prototype iterations within 10 working days.

Each batch of B12 oral spray is tested for potency, microbial limits, heavy metals and dose uniformity. We retain samples for 24 months. The facility holds GMP, ISO 22000 and HACCP certifications. Halal, vegan and certifications are available for relevant formulas. Our QC team releases batches only after all tests pass, and we provide a certificate of analysis with every shipment.

For export, we ship from Shenzhen and Hong Kong ports. Standard lead time for mass production is 20-35 working days after sample approval and receipt of deposit. We handle labelling compliance for the US, EU, UK and Middle East, including allergen statements and supplement facts panels. Air freight takes 5-10 days to the US or EU; sea freight takes 25-40 days. We can arrange DDP terms if needed.

Every batch of vitamin B12 oral spray is tested against a written specification before release. Identity is confirmed by HPLC against a certified reference standard, and potency is assayed to ensure the declared mcg per actuation is within 90-110% of label claim. Microbial limits follow USP <61> and <62> or Ph. Eur. 5.1.4, with total aerobic count below 100 cfu/ml and absence of specified pathogens. Heavy metals are screened by ICP-MS against ICH Q3D limits, and spray performance is checked for dose uniformity and actuation count.

Testing occurs at three points: incoming raw materials, bulk solution before filling, and finished packaged units. Bulk solution is held no longer than 24 hours before filling to limit degradation. Finished units are sampled from the start, middle and end of each filling run to confirm homogeneity. Retained samples of every batch are stored at 25°C/60% RH and 30°C/65% RH for the full shelf life plus 12 months, so any future query can be investigated against the original material.

The certificate of analysis (COA) issued with each batch lists batch number, fill volume, B12 form and potency, microbial results, heavy metals, dose uniformity, spray count, appearance and pH where relevant. It also states the release date and the specification version used. A stability protocol covering 0, 3, 6, 12, 18 and 24 months is available for products intended for EU or US markets, with accelerated data at 40°C/75% RH for 6 months to support shelf-life claims.

B12 oral sprays are filled into 15 ml, 20 ml or 30 ml PET or glass bottles with metered pump actuators. Standard closures include a tamper-evident overcap and a clear shrink band. For brands expanding into unit-dose formats, we also fill stick packs and sachets, though the spray format remains the primary line. Cartons can be printed with lot number, expiry date and a scannable barcode. We hold bottle and actuator tooling for common neck sizes, which shortens sampling time for repeat orders.

For US dietary-supplement labels, we structure the Supplement Facts panel to 21 CFR 101.36, including the B12 form, amount per serving, percent daily value and the required footnote. EU labels follow Regulation (EU) No 1169/2011 and the Food Supplements Directive, with nutrition declaration, allergen statement where applicable and the name and address of the food business operator. Lot and expiry coding is applied by inkjet or laser to the bottle base and carton, in a format agreed at artwork approval.

Retail-ready packing includes Amazon FNSKU labels applied over the barcode or on the carton, poly-bagged units where required, and carton dimensions that meet typical marketplace prep rules. Master cartons are specified with gross weight, dimensions and case pack count, and pallets are built to 1,200 x 1,000 mm or 1,200 x 800 mm with stretch wrap and edge boards. We can supply dielines and artwork templates so brand owners can complete label design before the first production run.

Sampling starts with a formulation brief and artwork draft. We provide unlabelled or plain-labelled samples in 7-10 working days, and a fully labelled pilot batch in 15-20 working days once artwork is approved. Pilot runs from 1,000 units are available for market testing, while standard MOQ is 1,000 units per SKU. Mass production runs 20-35 working days from receipt of deposit and approved artwork, depending on bottle and actuator availability.

Air freight is typically used for pilot batches and time-sensitive launches, with transit of 5-10 days to the US or EU. Sea freight suits full-pallet orders, with transit of 25-35 days to US west coast ports and 30-40 days to EU ports. We quote EXW, FOB Shenzhen or Hong Kong, and DDP for buyers who prefer a landed-cost price. DDP includes import clearance and duties but requires a valid product registration or notification where the destination market demands one.

Shipping documents include the commercial invoice, packing list, certificate of analysis, material safety data sheet (MSDS) for the finished spray, and a free-sale certificate where required by the destination authority. For plant-derived excipients we can provide phytosanitary certificates or statements of origin. Halal and vegan certificates are issued by third-party bodies and are arranged at order confirmation, not after production, so lead times remain predictable.