Prostate Capsule Manufacturer for Saw Palmetto and Botanical Blends

Our encapsulation suite runs three automatic filling lines with a combined capacity of 1.2 million capsules per shift. We handle powder blends, granulates and small-pellet fills. For prostate formulas, we typically blend saw palmetto extract with pygeum, nettle root, zinc and selenium. We use a 500-litre V-blender and a 300-litre ribbon blender to achieve uniformity. Each blend is sampled at three points and tested for uniformity by HPLC. We can fill 500 mg to 1,200 mg per capsule with a fill weight tolerance of ±3%. This matters for dosage-sensitive ingredients like saw palmetto, where label claims often sit at 320 mg per serving.

We also run low-moisture fills for hygroscopic ingredients. The plant maintains a relative humidity below 45% in the filling rooms. This prevents clumping and extends shelf life. For vegan and vegetarian brands, we stock HPMC and pullulan shells in sizes 0 to 2. We can also produce two-piece capsules with enteric coating for delayed release. Changeover between SKUs takes 4 to 6 hours, including line clearance and cleaning. That keeps small batch runs practical without long downtime. We can produce 1,000 to 50,000 units per SKU per run.

Saw palmetto extract is the anchor ingredient in most prostate formulas. We source it at 85% fatty acids and 0.5% phytosterols, standardised by GC. Pygeum africanum extract comes in at 13% phytosterols. Nettle root extract is standardised to 0.8% silica. Zinc is usually zinc gluconate or zinc citrate at 15 mg per capsule. Selenium is often selenomethionine at 200 mcg. We can combine these in a single blend or split them across two capsules for dosage flexibility. We also work with lycopene, pumpkin seed oil powder and beta-sitosterol.

Ingredient interactions matter. Zinc and selenium compete for absorption if not properly buffered. We adjust the blend matrix with microcrystalline cellulose and magnesium stearate at 1-2% to keep flowability without affecting dissolution. For oil-based ingredients like pumpkin seed oil, we use a powdered carrier or a two-piece capsule with a liquid fill. We test every incoming lot for heavy metals, pesticides and microbials. We also run accelerated stability studies at 40°C and 75% RH for 3 months. That gives you real data for shelf-life claims, not assumptions.

Our facility is GMP-certified and holds ISO 22000 and HACCP. We are FDA-registered for dietary supplements. We also carry halal and certifications for relevant lines. Every batch of finished capsules is tested for potency, disintegration, microbial limits and heavy metals. We retain samples for 2 years. Certificates of analysis are issued per batch. We can also provide allergen statements, GMO-free declarations and country-of-origin documentation. For EU buyers, we supply documentation for novel food and health claim review. For Middle East buyers, we provide halal certificates per shipment.

We ship from Shenzhen and Hong Kong ports. Typical lead time for mass production is 20-35 working days after sample approval. We handle bottling, labelling and cartoning in-house. Bottle sizes range from 30 cc to 120 cc. We can apply induction seals, child-resistant caps and tamper-evident bands. MOQ for retail bottling is 1,000 units per SKU. For pilot runs, we can produce 500 units. We work with freight forwarders for air and sea shipments. We also support Amazon FBA prep and direct-to-3PL delivery. Payment terms are 30% deposit, 70% before shipment.

Every prostate capsule batch is sampled at three points: incoming raw material, in-process blend, and finished capsules. Identity testing uses HPLC or TLC for saw palmetto extract and pygeum, confirming fatty acid and phytosterol profiles against reference standards. Potency assays quantify total fatty acids or sterols to within 95-105% 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 tested by ICP-MS, and disintegration is checked at 37°C in water for gelatin and HPMC shells.

A Certificate of Analysis (COA) is issued per batch and includes the product name, batch number, manufacturing date, expiry date, tests performed, specification limits, results, and the analyst and QA sign-off. We retain samples for 24 months beyond the expiry date in a temperature-controlled archive. Stability follows a bracketed protocol: 0, 3, 6, 12, 18 and 24 months at 25°C/60% RH, with accelerated conditions at 40°C/75% RH for 6 months. Parameters monitored include potency, moisture, microbial count and dissolution where applicable.

Blend uniformity is verified by taking ten random samples from the mixer and assaying each for the marker compound. Acceptance criteria require a relative standard deviation of 5% or less. Capsule fill weight is checked every 15 minutes on the filling line, with a target of ±5% of the nominal weight. Any out-of-specification result triggers a deviation report, root cause investigation, and a decision on rework or rejection. Batch records are kept for five years and are available for buyer review during audits.

For buyers requiring third-party verification, we can arrange testing at an ISO 17025-accredited external laboratory at cost. Typical turnaround for a full panel is 7-10 working days. We do not release any batch without a completed COA and QA release signature. Documentation is provided in English as standard, with bilingual English-Chinese versions available on request.

Prostate capsules can be packed in HDPE bottles (60, 90, 120, 180 or 240 count), blisters (10, 12 or 15 capsules per blister, with aluminium or PVC/PVDC backing), stick packs (single-dose powder or granule, not applicable to capsules), or sachets for sample sizes. Bottles are induction-sealed and fitted with child-resistant or standard caps. We stock white, amber and opaque HDPE bottles in 100 ml, 150 ml, 200 ml and 300 ml sizes. Blister tooling is available for common capsule sizes (0, 00, 1).

For the US market, labels must include the statement of identity, net quantity of contents, supplement facts panel, ingredient list, allergen declaration, and the manufacturer/distributor name and address. The FDA does not pre-approve labels, but we check that all mandatory elements are present and that structure/function claims carry the required disclaimer. For the EU, we verify that the label complies with Regulation (EU) No 1169/2011 and the nutrition and health claims regulation. Lot and expiry coding is applied by inkjet or laser, with format YYYYMMDD and a best-before date calculated from stability data.

Cartons are specified as 5-ply corrugated with a minimum burst strength of 200 psi. Each carton holds 12, 24 or 48 bottles depending on size. Pallets are standard 1200 x 1000 mm or 1200 x 800 mm, stretch-wrapped and strapped, with a maximum height of 1.8 m. We can print and apply Amazon FNSKU labels, and we follow Amazon's packaging requirements for poly bags (suffocation warning) and sets. Retail-ready packaging with display-ready trays is available for club stores and pharmacies.

Before mass production, we provide a digital label proof for buyer sign-off. Physical proofs can be supplied at cost. We maintain a library of dielines for common bottle and carton sizes. If the buyer supplies artwork, we check resolution (minimum 300 dpi), bleed (3 mm) and colour mode (CMYK). We do not alter label content without written approval. Packaging components are inspected for dimensional accuracy and print quality against the approved proof.

The minimum order quantity is 1,000 units per SKU for retail bottling, and 500 units for pilot runs. Samples are typically ready in 7-10 working days after receipt of raw materials and label artwork. Sample costs are credited against the first mass production order. Mass production takes 20-35 working days after sample approval, depending on capsule type, packaging format and whether new tooling is required. We confirm the schedule in a proforma invoice before production starts.

For delivery, we offer EXW, FOB (Shenzhen or Hong Kong), and DDP for select destinations. Air freight is used for urgent orders or small volumes (typically under 500 kg), with transit times of 5-10 days to the US or EU. Sea freight is more economical for larger orders, with transit times of 25-40 days depending on port. We provide a packing list, commercial invoice, and bill of lading. For DDP shipments, we handle customs clearance and duties, and provide a delivery note.

Documents provided with each shipment include the Certificate of Analysis, Material Safety Data Sheet (MSDS) where applicable, and a free-sale certificate for markets that require it. For botanical ingredients, a phytosanitary certificate can be arranged if the destination country mandates it. We also provide a certificate of origin. All documents are issued in English. Buyers are responsible for confirming import requirements in their own market, including any registration or notification obligations.

We recommend booking sea freight at least 45 days before the required delivery date to allow for production, documentation, and port handling. For air freight, allow 30 days. We can consolidate orders from multiple SKUs into a single shipment to reduce freight costs. Our logistics team provides tracking information and responds to queries within one business day. We do not ship without a signed proforma invoice and receipt of the agreed deposit.