HPMC Capsule Manufacturer for Your Supplement Brand

Our plant operates eight automated encapsulation lines dedicated to HPMC capsules. Each line can fill 60,000 to 90,000 capsules per hour, depending on fill weight and powder flow. We use capsule filling machines from reputable suppliers, with inline weight checks every 15 minutes. This ensures fill weight variation stays within ±5% for most formulations. For low-dose actives, we can add a pre-blending step to improve content uniformity.

We handle both powder and pellet filling. For powder blends, we use a ribbon blender or V-blender to achieve homogeneity. For pellets, we use a gravity-fed system to avoid segregation. After filling, capsules go through a metal detector and checkweigher before bottling. We can also print batch numbers and expiry dates directly on the capsule or on the label. Our team works with your formulation or helps you develop one from scratch.

HPMC capsules have a low moisture content (typically 4–6%), which makes them suitable for hygroscopic ingredients that would degrade in gelatin capsules. They also resist cross-linking, so there is no risk of pellicle formation with reactive actives like aldehydes. We have experience encapsulating probiotics, herbal extracts, vitamins, minerals, amino acids, and mushroom powders. For oily or liquid ingredients, we can use a liquid filling system or convert to a powder blend with an absorbent carrier.

If your formula contains acidic ingredients (e.g., vitamin C, betaine HCl), HPMC is a better choice than gelatin because it does not react with the fill. We also offer enteric-coated HPMC capsules for delayed release in the intestine. For vegan claims, we ensure no animal-derived ingredients are used in the capsule shell or the fill. We can source organic-certified HPMC shells if your product requires USDA organic or EU organic status.

Every batch of HPMC capsules we produce is tested for appearance, fill weight, disintegration, and microbial limits. We follow USP <2040> and Ph. Eur. methods for disintegration. Our in-house lab can run HPLC for potency assays if you provide a validated method. We retain samples from each batch for two years. For export to the US, we are an FDA-registered facility (not FDA-approved). For the EU, we comply with EC No 1935/2004 for food contact materials and can provide a declaration of compliance.

We also support halal certification through third-party auditors. If your brand needs a vegan claim, we provide a statement that the capsule shell and fill contain no animal derivatives. Our documentation package includes certificate of analysis (CoA), material safety data sheets (MSDS), and certificate of origin. For Middle East markets, we can arrange halal certification from a recognised body. We handle all export paperwork, including commercial invoice, packing list, and bill of lading.

Every HPMC capsule batch is tested at three stages: incoming shell inspection, in-process fill checks, and finished-product release. Incoming shells are verified for dimensions, colour, and moisture content (typically 3–6% w/w). During filling, we check fill weight every 30 minutes against your target, with an acceptance range of ±5% for most products. After filling, samples are sent to our in-house lab for identity, potency, microbial limits, heavy metals, and disintegration testing. Disintegration for HPMC capsules is typically 10–15 minutes in purified water at 37°C, depending on shell thickness and fill.

Microbial testing follows USP <61> and <62> methods, with total aerobic count limits of 10³ CFU/g and absence of specified pathogens in 10 g. Heavy metals are screened by ICP-MS for lead, cadmium, arsenic, and mercury, with results reported against ICH Q3D oral limits. Potency testing is performed only when your formula contains an active marker ingredient, using HPLC or titration methods validated for that compound. Identity testing uses FTIR or HPLC fingerprinting against a reference standard. All results are recorded in a batch record that traces shell lot, excipient lots, and operator ID.

The certificate of analysis (COA) issued with each batch includes product name, batch number, manufacturing date, expiry date, fill weight, capsule size, and test results with specification limits and pass/fail status. It also lists the method used for each test and the signature of the QC manager. We retain samples of every batch for 12 months beyond the assigned shelf life, stored under controlled conditions (25°C/60% RH or 30°C/65% RH). Stability protocols follow ICH Q1A(R2) guidelines, with testing at 0, 3, 6, 12, 18, and 24 months for long-term studies and 0, 3, and 6 months for accelerated conditions.

For products requiring halal certification, we provide separate documentation confirming that the HPMC shells and any excipients meet the relevant religious standards. If your formula includes probiotics or sensitive ingredients, we can adjust the fill environment to below 30% RH and use nitrogen flushing. Batch records and COAs are available in English and can be translated into other languages on request. We do not release any batch without a completed COA and a signed release by the quality assurance team.

We offer primary packaging in HDPE bottles (30, 60, 90, 120, 180, or 250 cc) with induction seals and child-resistant caps, blisters (PVC/PVDC or alu-alu), stick packs, and sachets. Bottle filling lines run at speeds up to 60 bottles per minute, with desiccant options for hygroscopic formulas. Blister lines accommodate 10, 12, or 14 capsules per card. For stick packs, we fill 2–5 g of powder or granules, but HPMC capsules are not suitable for stick packs unless the capsule is placed inside a larger sachet. We can also supply bulk capsules in double polyethylene bags inside fibre drums for customers who fill and package in their own facility.

For the US market, we design labels to include the statement of identity, net quantity of contents, ingredient list, and the Supplement Facts panel with all required nutrients, % Daily Value, and serving size. We also include allergen declarations (e.g., “contains no milk, egg, fish, shellfish, tree nuts, wheat, peanuts, soybeans”) and the mandatory “Distributed by” or “Manufactured for” statement. For the EU, labels comply with Regulation (EU) No 1169/2011 and the Food Supplements Directive 2002/46/EC, including the “food supplement” wording and recommended daily portion. We do not provide legal review, but we can format your approved artwork and flag missing elements.

Lot and expiry coding is applied by inkjet or laser on the bottle base, label, or carton, with formats such as YYMMDD and best-before dates. We can also add a GS1 DataMatrix or linear barcode (UPC-A or EAN-13) as required by retail customers. For Amazon FNSKU labelling, we print and apply the FNSKU barcode over the original barcode or on a separate label, and we can poly-bag bottles with a suffocation warning if needed. Cartons are typically 12, 24, or 48 bottles per shipper, with pallet configurations of 48–60 cartons per standard 1200×1000 mm pallet, stretch-wrapped and edge-protected for export.

Retail-ready packaging includes tamper-evident seals, lot-specific expiry dates, and a batch number that links to the COA. We can insert your leaflet or patient information sheet, and we offer shrink-wrapping for multi-packs. For blisters, we print the lot and expiry on the foil or carton. All packaging materials are food-grade and meet EU 10/2011 and FDA 21 CFR 174-186 requirements. We do not print prices or retailer-specific stickers unless you provide the artwork. Before mass production, we supply a packaging mock-up or digital proof for your approval, and we retain a reference sample of each packaging component for traceability.

Sample lead time for HPMC capsules is 7–10 working days after we receive your formula, shell specification, and packaging artwork. Samples are provided free of charge for standard shells and fill weights, but you cover the courier cost. If your formula requires a new shell colour or a custom size, add 5–7 days for tooling and colour matching. We send samples with a preliminary COA and a stability summary based on accelerated data. For pilot runs, the minimum order is 1,000 capsules per SKU, and we can supply them in bulk or in small bottles for your own testing.

Mass production starts after you approve the sample and pay the deposit (typically 30% advance, 70% before shipment). The production window is 20–35 working days for standard orders, depending on shell availability and packaging complexity. Bottling and labelling add 5–7 days; blister packing adds 7–10 days. If your order exceeds 100,000 capsules, we may schedule it in multiple batches to meet the lead time. We provide a production schedule within 3 working days of order confirmation, and we update you weekly on progress.

Shipping options include air freight (5–10 days door-to-door) and sea freight (25–35 days port-to-port). We work with Incoterms EXW, FOB Shenzhen or Hong Kong, and DDP for select destinations. For DDP, we handle customs clearance and duties, but we need your company name and tax ID for the import declaration. We provide a commercial invoice, packing list, bill of lading or airway bill, COA, MSDS (if applicable), and a free-sale certificate for each shipment. For products containing plant-derived ingredients, we can arrange a phytosanitary certificate if your country requires it. We do not ship without a signed order confirmation and payment as agreed.