5-HTP Capsule Manufacturer for Global Supplement Brands

Our encapsulation suite runs two automatic lines with a combined output of 120,000 capsules per hour. For 5-HTP, we use hydroxypropyl methylcellulose (HPMC) or gelatin shells in sizes 0 to 3. The plant operates under controlled temperature (18-22°C) and relative humidity (45-55% RH) to protect 5-HTP from moisture uptake. We granulate 5-HTP with microcrystalline cellulose or dicalcium phosphate before encapsulation to improve flow and weight uniformity. Weight variation stays within ±5% across a 100,000-capsule batch.

Batch sizes range from 50,000 to 500,000 capsules. Changeover between SKUs takes 4-6 hours, including line clearance and equipment sanitation. We run 5-HTP campaigns separately from high-potency or allergen-containing products to prevent cross-contact. If your formula includes complementary ingredients such as vitamin B6, magnesium or L-theanine, we blend them in a V-blender for 15 minutes at 12 rpm. Every batch gets an in-process check at 30-minute intervals for fill weight, lock length and appearance.

5-HTP (5-hydroxytryptophan) is extracted from Griffonia simplicifolia seeds. Standardised material typically contains 98% 5-HTP. It is hygroscopic and degrades with light and oxygen exposure. We recommend amber or opaque HPMC capsules and a nitrogen flush during packaging. Common excipients include microcrystalline cellulose (20-30% w/w), magnesium stearate (0.5-1.5%) and colloidal silicon dioxide (0.5-1%). If you want a clean-label product, we can compress 5-HTP with rice hull or acacia fibre instead of magnesium stearate.

Dosage forms go beyond standard capsules. We can produce delayed-release capsules with an enteric coating for targeted intestinal release, or vegetarian capsules for EU and Middle East markets. For a 100 mg 5-HTP capsule, typical total fill weight is 350-450 mg. We also offer 5-HTP in powder stick packs or tablets if your brand requires multiple formats. Flavour masking is available for chewable or powder formats using natural mint or berry systems. Stability testing at 40°C/75% RH for 6 months is standard before we lock a formula.

Every 5-HTP batch is tested for identity, potency, heavy metals, microbial limits and residual solvents. We use HPLC for 5-HTP assay and ICP-MS for lead, cadmium, mercury and arsenic. Microbial testing covers total aerobic count, yeast and mould, E. coli and Salmonella. We retain samples for 24 months. Certificates of Analysis (CoA) are issued per batch. For EU clients, we provide documentation for novel food or traditional food status where applicable. For US clients, we supply a facility registration number and can support your FDA prior notice filing.

Our facility holds GMP, ISO 22000 and HACCP certifications. Halal certificates are available for specific production runs. and vegan certification can be arranged if your formula qualifies. We prepare technical data sheets, allergen statements and nutritional panels. For the Middle East, we can provide halal certificates from recognised bodies and coordinate third-party testing for GCC conformity. Audit support includes on-site inspections and document review. We do not claim FDA approval; our facility is FDA-registered as a dietary supplement manufacturer.

We offer high-density polyethylene (HDPE) bottles from 30 cc to 500 cc, with induction seals and child-resistant or standard closures. Blister packs are available in PVC/PVDC or aluminium-aluminium for moisture-sensitive formats, and stick packs or sachets are available for powder blends or single-serve capsules. Bottle filling runs at up to 120 bottles per minute on the automatic line, with in-line checkweighers and metal detection. Cartons are specified to your artwork, typically 24 or 48 bottles per shipper, and pallets are built to 1,200 mm × 1,000 mm or 1,200 mm × 800 mm depending on destination.

For US retail, we support FDA dietary-supplement label elements: statement of identity, net quantity of contents, supplement facts panel with serving size and percent daily value, ingredient list in descending order of predominance, and the mandatory disclaimer for structure/function claims. We do not write claims for you, but we check that the label you supply contains the required elements before printing. Lot and expiry coding is applied by inkjet or laser at the filling line, with format options such as YYYYMMDD or best-before date, and the code is recorded in the batch record for traceability.

Amazon and other marketplace sellers need FNSKU labels applied over the barcode or printed on the carton. We can apply FNSKU labels, poly-bag units and insert your retail-ready carton markings. For EU retail, we check that the label includes the food business operator address, allergen statements where applicable and nutrition declaration if required. We do not provide regulatory advice for each market, but we can confirm what is printed on the artwork you approve and keep a signed approval record before the print run.

Packaging materials are specified with food-contact compliance declarations. Bottles and closures are supplied with food-grade certificates, and blister films with migration test data. If you need child-resistant packaging for the US market, we use closures tested to 16 CFR 1700.20 and keep the test reports on file. Carton strength is typically 32 ECT or 44 ECT depending on pallet height, and we can run drop tests to ISTA 1A on request before mass production.

The minimum order quantity for 5-HTP capsules is 1,000 units per SKU for retail bottling, with a 1,000-unit pilot run available for new brands that need market samples. Sample production takes 7 to 10 working days after artwork and specification approval, and the sample is shipped by courier at your cost. Mass production runs 20 to 35 working days after sample approval, depending on capsule size, packaging format and whether the label is printed in-house or supplied by you. We confirm the production window in the proforma invoice.

Shipping options are air freight and sea freight. Air freight from Shenzhen or Hong Kong to US and EU hubs typically takes 5 to 10 days door to door for 100 kg to 500 kg shipments. Sea freight to Los Angeles or Rotterdam takes 25 to 40 days port to port, with full container load or less-than-container load options. We can quote EXW, FOB Shenzhen or Hong Kong, and DDP for select destinations where our forwarder provides door delivery and customs clearance. Incoterms are stated on the proforma invoice and confirmed before production.

Documents provided with each shipment include the commercial invoice, packing list, certificate of analysis per batch, material safety data sheet (MSDS) for the finished capsules, and a free-sale certificate issued by the local authority where required by the destination country. For plant-based capsules we can supply a vegan statement, and for markets that require it, a halal certificate covering the capsule shell and the 5-HTP ingredient. Phytosanitary certificates are not normally applicable to encapsulated 5-HTP, but we can arrange one if your import authority requests it.

Payment terms are typically 30% deposit with the balance against the bill of lading, or 100% before shipment for orders under 5,000 units. We accept bank transfer and can discuss letters of credit for orders above 20,000 units. Production scheduling is confirmed only after deposit and artwork approval, so the 20 to 35 working day window starts from the later of those two dates. If you need a shorter window, ask about our express line, which can compress production to 15 working days for an additional fee.