L-Theanine Capsule Manufacturer for Global Brands

Our Guangdong plant runs automated capsule filling lines with a daily capacity of up to 500,000 capsules. We fill sizes 0, 1 and 2, with fill weights from 100 mg to 400 mg of L-Theanine. Standard capsule shells are bovine gelatin; HPMC (vegan) shells are available at no extra tooling cost. We can add magnesium stearate or silicon dioxide as flow agents, or produce a clean-label formula with no excipients. For combination products, we blend L-Theanine with magnesium, GABA, melatonin or herbal extracts in the same capsule.

Every run starts with a 1,000-unit pilot batch for stability and dissolution testing. The pilot uses the same blend and fill parameters as the commercial run, so scale-up is predictable. We hold 200 kg of L-Theanine raw material in stock, which covers about 500,000 capsules at 400 mg. This reduces lead time on repeat orders to 20–25 working days. If you need a smaller trial, we can produce 500-unit sample batches for internal review before you commit to a full MOQ.

We source L-Theanine from two qualified suppliers in China and Japan. Both provide material with 98%–102% assay by HPLC, heavy metals below 10 ppm, and a residual solvent profile that meets USP <467> requirements. Each lot arrives with a certificate of analysis (COA), and we retain a third-party lab to verify purity, microbial limits and pesticide residues. The ingredient is water-soluble and stable in capsule form, with a typical shelf life of 24 months when stored below 25°C and 60% relative humidity.

For formulation, L-Theanine blends well with magnesium glycinate, GABA, 5-HTP and chamomile extract. It has a mild, slightly sweet taste and no aftertaste, so taste-masking is rarely needed. If you are developing a sleep or calm-focus product, we can adjust the ratio of L-Theanine to complementary ingredients and run a 2-week accelerated stability study. We also offer organic-certified L-Theanine for USDA or EU organic claims, subject to a 4-week sourcing lead time.

Our facility is GMP-certified and holds ISO 22000 and HACCP. We operate a documented quality management system with batch records for every run. Incoming raw materials are quarantined until QC release. In-process checks include capsule weight variation (target ±5%), disintegration time (under 30 minutes for gelatin, under 45 minutes for HPMC) and visual inspection for defects. Finished capsules are tested for assay, microbial limits, heavy metals and moisture. We retain samples for 2 years and can provide full documentation for your regulatory filings.

For markets in the EU and UK, we supply a technical file with ingredient specifications, allergen statements and a statement of no GMO. For the Middle East, we arrange halal certification through a recognised body. certification is available on request. We do not claim FDA approval, but our facility is FDA-registered and can be audited by your team or a third-party inspector. We also support label reviews to help you avoid non-compliant claims in your target market.

Every L-Theanine capsule batch is tested at three points: incoming raw material, in-process blend, and finished capsules. Raw material is sampled per lot and screened for identity by FTIR, potency by HPLC against a 98% specification, microbials (total plate count, yeast and mould, E. coli, Salmonella), heavy metals (lead, arsenic, cadmium, mercury) and residual solvents where the supplier's route requires it. Finished capsules are tested for assay, uniformity of mass, disintegration and, where you specify, dissolution.

A Certificate of Analysis accompanies each shipment. It lists the product name, lot number, manufacture and expiry dates, the specification range and the measured result for each test, the method reference and the signature of the releasing QC officer. If your regulatory team needs a specific template, we can align the COA format to your requirements before the first production run rather than after.

Retention samples of every lot are held for at least two years beyond the expiry date, stored under labelled conditions. A stability protocol runs on the finished capsule at 25°C/60% RH and 40°C/75% RH, with assay, moisture, disintegration and microbial checks at 0, 3, 6, 12, 18 and 24 months. Accelerated data supports the shelf-life claim you print; real-time data is added to the file as it accrues.

Deviation handling is documented. If an in-process check falls outside the specification, the batch is quarantined, an investigation is opened and the disposition is recorded before release. Buyers who audit the facility can review the deviation log, the retention sample register and the stability file during the visit. We do not release a lot on a verbal approval; the signed batch record is the release gate.

Capsules can be packed in HDPE bottles from 30 to 180 count, in blister packs, or in single-serve sachets for stick-pack formats. Bottles take induction seals, desiccant or cotton, and child-resistant or standard closures depending on your market. Blisters use PVC/PVDC or alu-alu where moisture protection matters. Cartons are printed to your artwork and can carry a QR code linking to your label or batch page.

For the US market we prepare labels against the FDA dietary supplement requirements: statement of identity, net quantity, supplement facts panel with the L-Theanine amount per serving, other ingredients in descending order, and the address of the distributor or manufacturer. We do not write your claims; we check that the panel structure and the mandatory elements are present before printing. Lot number and best-by date are inkjet-coded on the bottle, carton and, where space allows, the capsule-side of the label.

Carton and pallet specifications are agreed before production. Standard export cartons are double-wall corrugated, with a gross weight typically under 15 kg for manual handling. Pallets are 1,200 x 1,000 mm or 1,200 x 800 mm, stretch-wrapped and corner-boarded, with a packing list showing carton count, net and gross weight and dimensions. Pallet height is kept within the limits your warehouse or Amazon fulfilment centre accepts.

For Amazon sellers we apply FNSKU labels, poly-bag or shrink-wrap where required, and a carton label that matches the shipment plan. We can print and apply FNSKU labels in-house or leave the cartons neutral for your own labelling. Retail compliance for the EU, UK and other markets is handled case by case: we confirm the label elements you supply and flag anything missing, but the regulatory responsibility for the claims and the notification remains with the brand owner.

Samples of a standard L-Theanine capsule formulation are dispatched in 7 to 10 working days, including the label mock-up if you supply artwork. Custom fill weights, custom excipient systems or a new capsule colour add roughly 5 working days for the trial batch. Sample costs are quoted per order and are usually credited against the first mass-production invoice.

Mass production runs 20 to 35 working days after sample approval and receipt of the deposit, depending on capsule count, packaging format and whether the artwork is new. A 1,000 unit order typically ships within the shorter end of that window; larger runs and blister or sachet formats sit at the longer end. We confirm the production slot in writing once the deposit clears.

Air freight suits pilot and mid-size orders and takes roughly 5 to 10 days door to door, depending on the destination airport and customs clearance. Sea freight is cheaper per kilogram for pallet volumes and takes 25 to 40 days to Europe or North America, plus clearance. We quote EXW, FOB and DDP; DDP is common for Amazon sellers who want the shipment delivered to a fulfilment centre with duties prepaid.

Each shipment is accompanied by the COA, a material safety data sheet, and a free-sale certificate where your market requires one. For plant-derived capsule shells or organic claims we supply the supporting certificates on request. Phytosanitary certificates are not normally relevant to a synthesised amino acid, but we will obtain one if your importing authority asks for it. Shipping documents are issued within 3 working days of dispatch.