Sustained-Release Tablet Manufacturer for Global Brands

Our facility runs two rotary tablet presses with force feeders and pre-compression rollers. We produce sustained-release tablets at rates up to 150,000 tablets per hour. For matrix systems, we use high-shear granulation followed by fluid-bed drying. For coated tablets, we operate perforated pan coaters with 200 kg batch capacity. Every batch is monitored for weight variation, hardness, friability and thickness.

Pilot runs start at 1,000 units for feasibility. We scale up to 1,000 units for retail bottling. Process parameters are locked after the first three validation batches. This ensures your 10th order matches your first. We also offer blister packing and bottle filling in-house.

Sustained release is achieved through matrix or reservoir systems. For hydrophilic matrices, we use HPMC K100M, K4M or E4M, often blended with lactose or microcrystalline cellulose. Hydrophobic matrices rely on ethylcellulose or glyceryl behenate. Coated systems use Eudragit RS/RL or Surelease. We adjust polymer ratios to hit target release curves at 1, 2, 4, 8 and 12 hours.

We also work with active ingredients that are challenging: high-dose botanicals, hygroscopic vitamins and low-solubility compounds. Our lab tests drug-excipient compatibility and stability under accelerated conditions (40°C/75% RH for 6 months). This reduces the risk of dose dumping or premature release.

EUPHM operates a GMP-certified facility audited annually. We hold ISO 22000, HACCP and halal certifications. For vegan claims, we maintain separate production lines. Our quality team performs full in-process testing: weight, hardness, disintegration and dissolution. We retain samples for 24 months. Each shipment includes a certificate of analysis with raw data.

We are FDA-registered for dietary supplements. We do not claim FDA approval. For EU and UK clients, we provide documentation for novel food and health claim dossiers. Middle East clients receive halal certificates per batch. Lead times average 20–35 working days from purchase order to dispatch.

Every sustained-release tablet batch is tested against a written specification before release. Identity and potency are confirmed by HPLC, with assay limits typically 95.0–105.0% of label claim. Microbial limits follow USP <61> and <62>, heavy metals are screened by ICP-MS to <10 ppm total, and disintegration testing is performed on the immediate-release portion of coated systems where applicable. Dissolution testing runs at 1, 2, 4, 8 and 12-hour points using USP <711> apparatus, and results are compared against the approved reference profile.

In-process controls run throughout compression: weight variation every 30 minutes, hardness and thickness hourly, and friability at start and end of each run. For matrix tablets, the polymer blend uniformity is verified by near-infrared spectroscopy before compression. Coated sustained-release tablets receive additional checks on coating weight gain and appearance. Any batch outside the dissolution specification is held for investigation and is not released.

A certificate of analysis accompanies every shipment. It lists batch number, manufacturing date, expiry date, specification results for identity, assay, dissolution at each time point, microbial limits, heavy metals, and appearance. Retention samples of each batch are stored at 25°C/60% RH and 30°C/65% RH for the full shelf life plus 12 months. Stability protocols follow ICH Q1A(R2) with testing at 0, 3, 6, 9, 12, 18 and 24 months, and accelerated conditions at 40°C/75% RH for six months.

Sustained-release tablets can be packed in HDPE bottles with induction seals, blister packs (PVC/PVDC or alu-alu), stick packs or sachets. Bottle sizes range from 30 cc to 500 cc, with child-resistant closures available. Blister tooling is custom-made for tablet dimensions and can accommodate 6, 10 or 12 tablets per card. Stick packs are typically 2–5 g fill and are suited to single-dose formats. Cartons are printed to your artwork with lot number and expiry date applied by inkjet or laser coding.

For US dietary-supplement labels, we format the Supplement Facts panel to 21 CFR 101.36, including serving size, amount per serving, % Daily Value where applicable, and the statement of identity. We do not add structure/function claims unless you provide substantiation. For EU markets, we follow Regulation (EU) No 1169/2011 for food supplements. Lot and expiry coding follows your required format, and we retain coded samples for traceability.

Cartons are specified with 350–400 gsm board, and pallets are standard 1200 x 1000 mm or 1200 x 800 mm with stretch wrap and corner boards. We can apply Amazon FNSKU labels and poly-bag units for FBA compliance, and we provide retail-ready carton markings including ITF-14 barcodes where required. Packaging line checks verify label accuracy, code legibility and seal integrity at start, middle and end of each shift.

Sample requests are handled within 7–10 working days for standard formulations, or 15–20 working days if a new release profile requires development. Samples are supplied with a preliminary COA and a dissolution profile. Pilot batches start at 1,000 tablets per SKU, and commercial MOQs are typically 50,000 tablets per SKU for bottles or 100,000 tablets for blisters, depending on packaging format.

Mass production takes 20–35 working days after artwork approval and receipt of deposit. This includes granulation, compression, coating where required, packaging and QC release. Air freight to Europe or North America takes 5–8 days door-to-door, while sea freight takes 28–35 days port-to-port. We ship under EXW, FOB Shenzhen or Hong Kong, or DDP for selected destinations. DDP terms include customs clearance and final delivery.

Documentation provided with each shipment includes the commercial invoice, packing list, certificate of analysis, material safety data sheet where applicable, free-sale certificate, and certificate of origin. For plant-based ingredients we can supply phytosanitary certificates on request. All documents are issued in English, and we can arrange legalisation or embassy attestation for markets that require it, with lead time quoted per destination.