Your brand, your artwork, our sterile line
You keep the market and the name on the carton. We fill it, test it and release it, and the paperwork that comes back is the kind an auditor asks for.
- Injectable formats
- 4
- Therapeutic groups
- 11
- Supplying
- 15 yrs
Why almost nobody builds their own injectable line any more
A sterile injectable facility is the most expensive thing to build in this industry and the hardest to keep qualified once it is built. Grade A laminar flow over the fill, validated sterilisation, environmental monitoring that never stops, an analytical laboratory that can release the batch and a quality head who signs for it. All of that has to be paid for whether the line runs one shift a month or three a day.
Contract manufacturing separates the two halves of the business. You own the brand, the artwork, the market and the customer. We own the plant, the licence and the batch record, and we carry the cost of keeping them qualified across everybody who books time on the line.
The practical effect is that a brand can launch a range without a plant, and an established company can add capacity without a capital cycle. What you are actually buying is not floor space. It is a documented batch you can stand behind in front of a purchase committee or a drug inspector.
What you keep
- Your brand name and trademark
- Your artwork, carton and leaflet
- Your market, pricing and customers
- Your product permissions where you hold them
What we can fill for you
Injectables only, which is the whole of what this site is licensed and equipped for. Counts are the products currently listed in each format.
Dry Powder Injection · 70 listed
Sterile dry powder filled into vials under Grade A laminar flow, reconstituted at the bedside. The bulk of the antibiotic range sits here.
IV Infusion · 11 listed
Large-volume parenterals in 100ml and 300ml presentations, terminally sterilised and released against a full sterility and pyrogen panel.
Liquid Injectable · 10 listed
Solution-filled ampoules and vials for molecules that stay stable in liquid, including the tray-packed emergency range.
Lyophilised Injectable · 5 listed
Freeze-dried cake presentations for heat-labile molecules where a dry powder fill would not hold potency across shelf life.
How an order moves through the plant
Five stages, each of which ends with something you can see rather than a status update.
Brief and feasibility
You send the molecule, the strength, the pack and the volume. We come back on whether it fits this licence and this line, and what the honest lead time is. If it does not fit, you hear that first rather than last.
Quotation and booking
A rate against the batch size, with the pack cost broken out so you can see what is formulation and what is packing. Line time is booked against a written date rather than a queue position.
Artwork and pack development
Your artwork is checked against the mandatory declarations before it goes to print, not after. Vial, ampoule, label, carton, leaflet and shipper are all settled at this stage so nothing holds the batch at packing.
Manufacture and release
The batch is made against a batch manufacturing record and held until the analytical results are in. Nothing ships on a promise that testing will follow.
Dispatch with documents
The consignment travels with its certificate of analysis and dispatch paperwork. You get the documents at the same time as the stock, not a fortnight later when somebody asks for them.
What comes back with every batch
This is the part that separates a manufacturing partner from a supplier. A delivery note proves stock moved. None of the rest of this can be produced after the fact.
Certificate of analysis, batch specific
Against the release specification for that product, signed off before dispatch, carrying the batch number printed on the carton in your hand.
Batch manufacturing record reference
The manufacturing and packing record for your batch is retained here and referenced on request, which is what an audit or a market complaint traces back through.
Sterility and pyrogen results where the format requires it
Terminally sterilised infusions and aseptically filled vials carry different panels. You get the one that applies to the product rather than a generic sheet.
Stability commitment across the shelf life
The expiry printed on your carton is supported by stability data held here, which is what a regulator asks to see when they ask how you arrived at it.
Dispatch and transport documentation
Invoice, packing list and, where the molecule needs it, the cold chain record for the leg we control.
What to check in any contract manufacturer
Ask all five of these of everyone you shortlist, including us. A partner who cannot answer them in writing is one you find out about during your first market complaint.
Before you send a brief
It depends on the format and the molecule, because a lyophilisation cycle and a large volume infusion run have very different economics. Send the product and the pack and you will get a real number rather than a slab.
We manufacture against permissions held for the site and its products. Where you are bringing your own brand into a molecule we already make, that is straightforward. A molecule that is new to this site is a longer conversation and we will say so before you plan a launch around it.
Either. Most brands leave the vial, carton and leaflet with us and supply only the approved artwork, because the pack then arrives already matched to the fill. If you have your own printer, that works too.
The molecule, yes. Your brand, your artwork and your pack, never. That distinction is the one worth being precise about with any contract manufacturer.
Send a brief and get a real lead time
Molecule, strength, pack and volume is enough to start. You will get feasibility and an honest date before you get a sales call.