Probiotics Tablet Manufacturer for Retail and Private Label

Probiotic powder is sensitive to moisture and heat, so we run tableting in a controlled suite held below 30% relative humidity. Two rotary tablet presses handle 250–1,200 mg fill weights, with output of 80,000–150,000 tablets per shift depending on size and hardness. Direct compression is standard for most strains; we use a granulation step only when a formula needs it for flow or content uniformity.

Every batch is weighed and blended under nitrogen where the formula allows. Compression force is logged per tablet, and we check weight variation, hardness, friability and disintegration against the agreed specification before the batch moves to coating or bottling. For chewable probiotics, we adjust the compression profile to keep the tablet soft enough to chew without crumbling in the bottle.

We work with lyophilised probiotic powders from established suppliers, including Lactobacillus, Bifidobacterium, Streptococcus and Bacillus strains. Overages are standard practice: if the label claims 10 billion CFU at end of shelf life, the formula is built with 12–15 billion CFU at manufacture, depending on the strain and the stability data. We can also add prebiotics such as inulin or FOS, plus excipients like microcrystalline cellulose, magnesium stearate and silicon dioxide.

Flavour and sweetener systems for chewable tablets include natural fruit powders, stevia, monk fruit and xylitol. For coated tablets, we use a thin film coat to reduce moisture ingress and mask any fermented note from the strains. We do not use animal-derived gelatine in probiotic tablets unless a client specifically requests it; most formulas are vegan by default.

Each probiotic tablet batch is tested for identity, potency, moisture content, microbial limits and heavy metals. CFU counts are run at release and again at intervals during stability testing, so the label claim holds through the declared shelf life. We retain samples for 24 months and can supply certificates of analysis, safety data sheets and allergen statements before shipment.

The facility is GMP-certified and holds ISO 22000 and HACCP. halal and vegan certifications are available depending on the ingredient list and the target market. For US and EU buyers, we provide documentation to support FDA-registered facility status and EU food contact compliance for bottles and closures. Shipping is arranged FOB Shenzhen or Yantian, with air freight for pilot runs.

Every probiotic tablet batch is tested at three stages: raw material receipt, in-process compression, and finished release. Identity testing by 16S rRNA sequencing or strain-specific PCR confirms each culture matches the declared strain. Potency is measured by plate count at release, with a specification of 100% of label claim at the time of manufacture. Microbial safety testing covers total aerobic count, yeast and mould, E. coli, Salmonella, and Staphylococcus aureus. Heavy metals (lead, cadmium, arsenic, mercury) are tested per ICP-MS against USP <232> limits. Disintegration testing follows USP <701> with a 30-minute limit for uncoated tablets.

The certificate of analysis (COA) for each batch lists strain identity, potency at release, microbial results, heavy metals, disintegration, appearance, average weight, hardness, and moisture content. Moisture is critical for probiotics and is specified at ≤3.0% for tablets. A retention sample of at least 200 tablets per batch is stored under controlled conditions (25°C/60% RH) for the shelf life plus one year. Stability protocols follow ICH Q1A(R2) with testing at 0, 3, 6, 12, 18, and 24 months under long-term conditions, and accelerated testing at 40°C/75% RH for six months. Potency overage is set at 30–50% above label claim to ensure the declared CFU count is maintained through expiry.

Documentation provided with each shipment includes the COA, a batch manufacturing record summary, and a declaration of allergen status. For markets requiring it, we supply a certificate of free sale and a phytosanitary certificate where applicable. All records are retained for five years and are available for audit by the brand owner or a third-party auditor. Our quality system is GMP and ISO 22000 certified, and we can provide a quality agreement covering testing responsibilities, deviation handling, and change control.

Probiotic tablets can be packed in HDPE bottles with induction seals and desiccant, blister packs (PVC/PVDC or alu-alu), stick packs, or sachets. Bottle sizes range from 30 to 120 tablets, with standard 60cc and 100cc HDPE bottles. Blister packs are available in 10, 14, or 21 tablet configurations. Stick packs and sachets are typically 2–5 g fill and are suited for powder or chewable formats. We can apply shrink bands, tamper-evident seals, and child-resistant closures where required. Desiccant options include silica gel canisters or molecular sieve sachets, with moisture barrier specifications provided for each format.

For the US market, labels must include the supplement facts panel with CFU counts at expiry, other ingredients, allergen declarations, and the DSHEA disclaimer. We can generate print-ready artwork from your content or work with your designer. Lot number and expiry date are inkjet-printed or laser-coded on the bottle, blister, or carton. Expiry dating is typically 18–24 months from manufacture, supported by stability data. Cartons are specified with dimensions, board grade (typically 300–350 gsm), and printing method (offset or digital). Pallet configurations are standard 1200x1000 mm or 1200x800 mm, with stretch wrapping and edge protectors.

For Amazon FBA, we apply FNSKU labels and poly-bag or shrink-wrap units as required. Retail compliance for the EU includes the address of the food business operator, nutrition declaration, and language requirements per member state. We do not provide regulatory advice but can supply the technical file and label review against your provided market requirements. Packaging materials are food-grade and meet EU 10/2011 and FDA 21 CFR 174-190 where applicable.

Sample lead time is 7–10 working days after receipt of a signed sample request and specification. Samples are provided free of charge for standard formulations; custom strain blends may incur a development fee, which is credited against the first production order. Mass production lead time is 20–35 working days after sample approval and receipt of a deposit. This window includes raw material procurement, tableting, coating (if applicable), packaging, and quality testing. Delays can occur if strain-specific raw materials are out of stock; we will notify you within 5 working days of order confirmation if this is the case.

Shipping options include air freight (5–10 days door-to-door) and sea freight (25–40 days port-to-port). We work with EXW, FOB Shenzhen or Hong Kong, and DDP terms. For DDP, we handle customs clearance and duties for most major markets, including the US, EU, UK, and Australia. Air shipments are typically used for pilot runs or urgent orders, while sea shipments are cost-effective for full container loads (FCL) or less-than-container loads (LCL). We provide a packing list and commercial invoice for each shipment.

Documents provided with each shipment include the COA, material safety data sheet (MSDS) if required, certificate of free sale, and phytosanitary certificate for relevant plant-derived ingredients. For halal certification, we provide the certificate from the certifying body. We do not provide a certificate of origin unless requested; this can be arranged through the local chamber of commerce. All shipments are palletised and stretch-wrapped, with desiccant added to containers for sea freight to control humidity.