Prostate Softgel Manufacturer for Retail and Private Label

EUPHM runs softgel lines with rotary die encapsulation, which handles oil suspensions and self-emulsifying systems. For prostate products, the typical fill is saw palmetto CO2 extract at 160 mg or 320 mg, pumpkin seed oil at 500 mg, lycopene at 5-15 mg, and zinc or selenium in oil-dispersible form. Fill weights from 500 mg to 1,500 mg are available, and we can adjust the gelatin shell to a vegan HPMC shell where the market requires it. Batch sizes start at 1,000 units per SKU for retail bottling.

The softgel format also removes the need for binders, glidants and coatings. That keeps the label shorter and reduces the risk of ingredient interactions during compression. For brands selling into the EU, the UK or the Middle East, we can match country-specific label claims and restricted-ingredient lists during formulation review, before samples are produced.

A prostate softgel usually combines two or three actives. Saw palmetto extract is standardised to 85-95% fatty acids and sterols, and is dosed at 160 mg or 320 mg per softgel. Lycopene from tomato extract is oil-soluble and is typically dosed at 5-15 mg. Zinc is included at 5-15 mg, often as zinc oxide or zinc citrate dispersed in the oil phase. Vitamin D3 and vitamin E are added at 10-25 mcg and 10-30 IU respectively. Pumpkin seed oil is used at 500-1,000 mg when it is the primary carrier oil.

We can also build combination formulas with nettle root extract, pygeum or boron. Because these actives have different solubility profiles, the formulation team confirms carrier oil, emulsifier and antioxidant levels before the first sample batch. Stability testing at 40°C and 75% RH runs alongside the sample stage, so the softgel that reaches your warehouse performs the same as the one approved in the lab.

EUPHM operates a GMP-certified facility with ISO 22000 and HACCP systems. Incoming raw materials are tested for identity, potency and heavy metals. Each prostate softgel batch is tested for fill weight, disintegration, peroxide value and microbiological limits. Certificates of analysis are issued per batch. For halal or vegan claims, we source certified raw materials and keep the relevant documentation on file for your QA team.

Shipping is arranged from Guangdong to the US, EU, UK and Middle East. We provide commercial invoices, packing lists, certificates of origin and, where required, health certificates for customs clearance. Mass production takes 20-35 working days after PO and artwork sign-off. For repeat orders, we hold approved formulations and artwork on file so reorders skip the sample stage and move straight to production scheduling.

Prostate softgels can be packed in HDPE bottles (30, 60, 90 or 120 counts), blister packs (10 or 12 per card), stick packs or sachets. Bottles are induction-sealed and can include a desiccant canister. Labelling follows the destination market. For the US, the FDA dietary supplement label requires a supplement facts panel with serving size, amount per serving, percent daily value where established, and a list of other ingredients. Allergen statements, storage conditions and a ‘keep out of reach of children’ warning are included where applicable. Lot and expiry codes are inkjet-printed on the bottle, carton and shipper.

Cartons are specified with dimensions, board grade and print process (offset or digital). Pallet configurations are provided for each SKU, including cartons per layer, layers per pallet and total cartons per pallet, with a standard 1,200 x 1,000 mm pallet or as required. For Amazon FNSKU and retail compliance, we can apply FNSKU labels, poly-bag units, and provide pack-out data. We do not manage Amazon seller accounts, but we prepare shipments to meet FBA requirements when instructed.

Sampling starts with a formulation brief and target dose. Sample lead time is 7-10 working days for standard formulations, including softgel samples and a draft COA. Mass production takes 20-35 working days after purchase order and artwork sign-off. MOQ is 1,000 units per SKU for retail bottling and 1,000 units for pilot runs. For new dies or custom shapes, add 10-15 working days for tooling.

Shipping options include air freight (5-10 days door-to-door) and sea freight (25-40 days port-to-port). Incoterms offered are EXW, FOB and DDP. DDP is available for the US, EU, UK and Middle East, with duties and taxes handled by our freight partners. Documents provided with each shipment include COA, MSDS, free-sale certificate, and phytosanitary certificate where relevant. Commercial invoice, packing list and bill of lading or airway bill are issued as standard.

Every prostate softgel batch is tested against a written specification before release. Incoming saw palmetto extract is assayed for fatty acid content (typically 85-95%), pumpkin seed oil for peroxide value and linoleic acid, lycopene for total carotenoids, and zinc for elemental content. Identity is confirmed by FTIR or HPLC fingerprint against a retained reference standard. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella, with limits set to USP <2021> or EU Pharmacopoeia as applicable.

In-process checks run at the softgel line: fill weight is verified every 30 minutes across a 10-capsule sample, seam integrity is inspected visually and by leak test, and shell thickness is measured on a destructive sample every two hours. After drying and polishing, finised softgels are tested for disintegration (target under 30 minutes in purified water at 37°C), potency of each active, and heavy metals (lead, cadmium, arsenic, mercury) by ICP-MS. Pesticide residues and residual solvents are tested when the extract supplier's risk profile requires it.

The certificate of analysis (COA) issued with each batch states the batch number, manufacture and expiry dates, specification limits, test methods and actual results for every parameter. A retention sample of at least 200 softgels per batch is held for the full shelf life plus six months. Stability follows a bracketed protocol: 0, 3, 6, 12, 18 and 24 months at 25°C/60% RH and 30°C/65% RH, with accelerated conditions at 40°C/75% RH for six months. Assay, disintegration and microbial tests are repeated at each interval.

Deviations are documented and investigated under a CAPA procedure before batch release. If a potency result falls outside the 95-105% label claim range, the batch is held, re-sampled and re-tested in duplicate. Only the QA manager can authorise release, and the signed COA is emailed to the buyer before shipment. Buyers can request the batch manufacturing record and deviation log for audit purposes.

Prostate softgels are typically packed in HDPE bottles with induction-seal liners and child-resistant caps for the US market, or in blister packs and stick packs for EU pharmacy channels. Bottle sizes range from 30 to 180 counts, with desiccant sachets added when the formula includes hygroscopic actives. Blister options include PVC/PVDC and aluminium-aluminium for moisture-sensitive formulas. Stick packs and sachets are available for single-dose formats, filled at up to 60 units per minute on the sachet line.

For US dietary supplements, the label must carry the statement of identity, net quantity of contents, supplement facts panel with serving size and per-serving amounts, other ingredients list, and the manufacturer or distributor name and address. The FDA disclaimer is required if structure-function claims are used. Lot number and best-by date are inkjet-coded on the bottle, carton and shipper, in a format agreed at artwork approval. EU labels require the nutrition declaration, allergens, and the food business operator address.

Cartons are specified to a minimum 200-test corrugated board for export, with pallet configuration of 48 or 60 cartons per layer and up to 1,200 kg per pallet. Shrink-wrap and edge protectors are standard. For Amazon FBA, we apply FNSKU labels on each unit, poly-bag or bubble-wrap as required, and print the FBA box labels with the correct shipment ID. Retail compliance checks cover barcode scannability (EAN-13 or UPC-A) and label placement tolerances of ±2 mm.

Artwork is proofed against a pre-press checklist before plate making. Buyers receive a PDF proof and a physical label proof for sign-off. Any change to the supplement facts panel or claims requires a new proof cycle, typically three working days. We keep approved artwork files for two years so repeat orders can be run without re-proofing unless regulations change.