Capsule Contract Manufacturing
Hard gelatin and HPMC (vegetarian) capsules filled with powders, pellets or mini-tablets, made under your brand by GMP-licensed manufacturers in India.
What matters in a hard capsule project
A hard capsule is a two-piece shell, filled on a machine with powder, granules, pellets or small tablets. The fill decides most of the project. Plain powder fills are routine. Delayed-release pellets, as used for omeprazole, esomeprazole and other acid-labile drugs, need pellet coating capacity or a reliable pellet supplier, and their dissolution has to be tested in acid and then in buffer.
The shell matters too. Gelatin is standard. HPMC shells suit vegetarian claims and moisture-sensitive fills, and some markets prefer them.
We shortlist plants that already fill your capsule type for your target market, and we share their approvals first.
Tell us this to get a quote
- Molecule(s) and strength
- Fill type: powder, granules, pellets (immediate, delayed or extended release), mini-tablets
- Shell: gelatin or HPMC, size, colour, printing
- Target market(s)
- Pack: blister, strip or bottle, pack size
- Annual volume and first-order quantity
- Your own formula and dossier, or the manufacturer's
What to check in a capsule manufacturer
Approvals for your market
WHO-GMP and a CoPP for most emerging markets; an inspection by your market's regulator for the EU, UK, US, Australia or PIC/S countries.
Pellet capability
Make the pellets in-house or buy them in? Both work, but bought-in pellets add a second supplier whose documents also go into your dossier.
Segregation
Beta-lactam antibiotics such as amoxicillin and cefalexin capsules must be filled in dedicated, segregated blocks. Ask which block your product runs in.
Moisture control
Gelatin shells go brittle when too dry and soft when too humid. Hygroscopic fills may need HPMC shells and Alu-Alu blisters. Ask for stability data on the pack you will use.
Dossier and bioequivalence
Check whether a CTD or ACTD dossier exists, who owns it, and whether bioequivalence data is available where your market needs it.
Fill weight control
Automatic fillers with in-line weight checks give tighter uniformity. Ask how fill weight is monitored during the run.
Gelatin or HPMC shell?
| Hard gelatin | HPMC (hypromellose) | |
|---|---|---|
| Source | Animal (bovine, porcine or fish) | Plant cellulose |
| Claims it supports | Halal with certified gelatin | Vegetarian and vegan, and halal |
| Moisture content of the shell | Higher; can pass moisture to sensitive fills | Lower; better for moisture-sensitive fills |
| Cost | Lower | Higher |
Changing the shell type on a registered product is usually a variation that needs regulator approval, so decide before registration.
How it works with PharmaTradz
You send the product, fill type, shell, market and volume.
Two or three plants that already fill that capsule type, with approvals and country of manufacture. Names under a confidential disclosure agreement when the requirement is firm.
Samples of an existing product, or development, dissolution and stability work for a new one.
Your brand, artwork and the dossier for your market.
Production and release with a batch-wise CoA; third-party pre-shipment inspection on request.
Scheduled batches with the same site, pellet source and documents.
Problems we see most often
Delayed-release pellets that fail acid resistance
Coating thickness or pellet quality varies from lot to lot. Ask for acid-stage dissolution results on several recent batches.
Brittle or sticky shells in storage
The shell has gained or lost too much moisture for the climate. Agree the pack against zone IVb stability data.
A second supplier hidden in the dossier
Bought-in pellets mean the pellet maker's documents and changes affect your registration. Ask who makes them before you file.
Have a capsule product in mind?
Send the molecule, fill type, shell, market and annual volume. We will tell you which manufacturers fit and what documents they hold.
Send your requirement Talk to our teamOther contract manufacturing
Building your own brand across several products? See white label and third-party manufacturing, or the CDMO and contract manufacturing guide hub.
