Softgel Contract Manufacturing
Soft gelatin capsules made under your brand by GMP-licensed manufacturers in India, for pharmaceutical or nutraceutical use and for export to regulated and emerging markets.
What a softgel project needs that a tablet project does not
A softgel is a one-piece sealed capsule, usually holding an oil, a solution or a suspension. It is made on a rotary-die machine: two ribbons of warm gelatin are formed, the fill is injected between them, and the dies seal and cut each capsule in one step. The capsules are then dried for several days until the shell reaches its target moisture.
That process is why fewer plants make softgels than tablets, and why the questions are different. The fill has to be compatible with the shell, the shell has to suit the climate and the buyer (gelatin type, halal, vegetarian), and every change-over means a new gel mass and die set, so minimum runs are larger.
We shortlist softgel manufacturers whose approvals, shell options and fill experience match your product and your market, and we share those approvals before you commit to anything.
Tell us this to get a quote
- Active ingredient(s), strength and fill type (oil, solution, suspension, paste)
- Shell: bovine, porcine or fish gelatin, halal-certified, or plant-based
- Capsule size, shape and colour, and any printing
- Target market(s) and whether it is a medicine or a supplement there
- Pack: blister type or bottle, pack size
- Annual volume and first-order quantity
- Your own formula and dossier, or the manufacturer's
What to check in a softgel manufacturer
Approvals for your market
A WHO-GMP certificate and CoPP from the Indian regulator cover most emerging markets. Regulated markets need the site itself inspected by that market (EU-GMP, US FDA, UK MHRA, TGA, or a PIC/S member).
Fill experience
Oils and oil solutions are routine. Suspensions, hydrophilic fills (PEG-based), and fills with a lot of water or extreme pH need a plant that has made them before, because they can soften, harden or leak through the shell.
Shell options
Bovine, porcine or fish gelatin, halal-certified gelatin for Muslim-majority markets, and starch-carrageenan shells for vegetarian claims. Not every plant runs all of them on the same lines.
Stability in hot, humid climates
Softgels can stick or leak at high temperature and humidity. Ask for real-time data at 30°C/75% RH (ICH zone IVb) if you sell into Africa, South-East Asia or Latin America, and agree the pack (Alu-Alu or PVC/PVdC blister, or bottle) on that basis.
Dossier and documents
A ready CTD or ACTD dossier for common molecules saves months. Check who owns it, and that stability, process validation and the batch record match the registered formula.
Capacity and lead time
Encapsulation lines run in campaigns. Ask how often your product can be scheduled, the drying time built into the lead time, and the minimum run per strength.
Medicine or supplement? It changes the licence and the paperwork
| Pharmaceutical softgel | Nutraceutical softgel | |
|---|---|---|
| Typical products | Vitamin D3 (cholecalciferol) prescription strengths, calcitriol, isotretinoin, nifedipine, progesterone, dutasteride, ciclosporin | Omega-3 fish oil, vitamin E, multivitamins, CoQ10, lycopene, evening primrose oil |
| Licence in India | Drug manufacturing licence from the State Licensing Authority, under the Drugs and Cosmetics Rules | FSSAI licence under the 2022 nutraceutical and health-supplement regulations |
| GMP standard | Revised Schedule M (from 2023); WHO-GMP for export | FSSAI hygiene and GMP rules; many export plants also hold WHO-GMP or NSF/GMP certification |
| Export documents | CoPP, GMP certificate, CTD/ACTD dossier, CoA | Free sale or health certificate, CoA, ingredient specifications, sometimes a CoPP-style certificate |
The same molecule can fall on either side depending on strength and the importing country. Vitamin D3 at high strength is a medicine in many markets and a supplement in others. We check how your target market classifies it before quoting.
How it works with PharmaTradz
You send the product, market and volume. If it is a supplement in one market and a medicine in another, we flag it now.
We match two or three manufacturers and share their approvals, shell options and country of manufacture. Manufacturer names can be disclosed under a confidential disclosure agreement when the requirement is firm.
Samples from existing products, or development and stability batches for a new formula. The fill and shell are fixed here.
Your brand, artwork and the dossier for your market. In regulated markets the site and dossier go through registration before commercial supply.
Production, drying, inspection and release with a batch-wise CoA. Pre-shipment inspection by a third party can be arranged.
Scheduled campaigns against your forecast, with the same site, formula and documents each time.
Problems we see most often
Leaking or sticky capsules on arrival
Usually heat and humidity in transit or storage, a pack that does not protect enough, or a fill that migrates into the shell. Agree the pack against zone IVb stability data before the first order.
Capsules that will not dissolve
Shell gelatin can cross-link over time, often triggered by aldehydes in the fill or packaging, and the capsule then fails dissolution. Ask what the manufacturer's stability data shows at the end of shelf life, not just at release.
A halal or vegetarian claim the paperwork cannot back
The claim has to be supported by the gelatin supplier's certificate and by the plant's line segregation. Ask for both before artwork goes to print.
Have a softgel product in mind?
Send the molecule or formula, strength, market and annual volume. We will tell you plainly 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. Related guide: Private-label nutraceutical contract manufacturing.
