API CDMO / Custom Synthesis
We develop and manufacture your API — from route to first GMP batch
Custom API synthesis and process development in India for a molecule you own. Route scouting through tech transfer, under NDA, in the same building that runs the reactor.
What this service covers
Custom API development for the molecule that is not on anyone's catalogue
CDMO — contract development and manufacturing — is for buyers who need an API that we, and often anyone else, do not make off the shelf. You own the target; we develop a route to it, prove that route at scale, and hand you a process with the analytical data to file behind it.
This is deliberately different from our API Manufacturing service, which is per-kilogram supply of our own eight molecules. Custom synthesis is a development project with its own scope, timeline and pricing.
You bring the target API — patented, off-patent or novel — and we develop a manufacturing route to it.
This is development work, priced by project. It is not the per-kilogram bulk supply of our own eight molecules.
Structures, routes and specifications are handled under NDA before any technical discussion begins.
The team that scouts the route runs the scale-up and the first GMP campaign in the same building.
Our capabilities
Route scouting to tech transfer, in four stages
Literature and freedom-to-operate review, then candidate synthetic routes assessed for cost, safety and impurity fate.
Reaction optimisation at lab scale, analytical method development and an early impurity profile.
Pilot batches to confirm the route behaves at volume, with in-process controls defined against the batch record.
Documented transfer into the GMP block — or to your own site — with the analytical package to support it.
Why Apex for CDMO
What a development partner should carry, not just a plant
These commitments are specific to custom development — our API manufacturing and contract manufacturing pages promise different things, because they are different jobs.
We develop with the plant in mind, so the process that works in the lab is the one that survives at scale.
The impurity profile is characterised during development, not explained to your auditor afterwards.
The molecule, the route and the data are yours. We do not add your compound to our own catalogue.
No hand-off between a lab that designed the route and a plant that has never seen it.
Developed and manufactured under one GMP system
CDMO & custom synthesis FAQs
How is a CDMO project different from your API manufacturing service?
API manufacturing is bulk supply of the eight molecules we already make, priced per kilogram. A CDMO project is development work on a molecule you own — we build the route, characterise the process and transfer it. The two are quoted completely differently.
Will you keep my molecule confidential?
Yes. We work under a non-disclosure agreement from the first technical conversation. Your structure, route and specifications are not shared and your compound is never added to our own portfolio.
Can you develop a route and then manufacture it for us?
Yes — that is the usual path. We can run the first GMP campaigns here after tech transfer, or transfer the documented process to your own site if you prefer to manufacture it yourself.
What information do you need to quote a CDMO project?
The target molecule, the intended market and scale, any known route or reference, and your quality expectations. The more you can share under NDA, the tighter the development plan and quotation.
Have a molecule you need developed?
Tell us the target, the market and the scale — under NDA — and we will come back with a development approach.