Contract Manufacturing
Dedicated capacity to manufacture your existing API at scale
API contract manufacturing in India for a process you already own. We provide the reactor time, the GMP system and the documentation — you keep the specification and the schedule you need.
What this service covers
Outsourced production for an API that already has a home process
Contract manufacturing is for buyers who have an established, validated API process and need capacity to run it — because their own plant is full, being qualified, or simply better used elsewhere. You keep the process; we keep it running.
This is not the same as our CDMO service, where we develop a route from scratch, and it is not per-kilogram supply of our own catalogue. It is your molecule, your specification, our floor and our documentation.
You bring an established API and its validated process; we run it at scale on your behalf.
This is outsourced production — reactor time and campaign scheduling — not route development.
We manufacture to your specification and method of analysis, released by our QC against your limits.
One campaign to cover a capacity gap, or a standing annual contract for continuity of supply.
How a contract runs
Process review to despatch, in four stages
Your batch record, specification and method of analysis assessed against our equipment and controls.
Documented transfer of your established process onto our block, with a confirmation batch where needed.
Reactor time and materials planned against your forecast, with a firm date given before you commit.
Batch manufactured to your spec, QC released, then packed and despatched with full documentation.
Why Apex for contract manufacturing
What an outsourcing partner should guarantee
These commitments are specific to running your established process — our API manufacturing and CDMO pages promise different things, because they are different jobs.
Capacity committed to your campaign so your supply is not queued behind someone else’s.
We run the route and specification you already validated — we do not redesign it underneath you.
The same batch records, deviation handling and QC release your auditor will expect to see.
Your process and specification are handled under NDA and never folded into our own portfolio.
Your process, run under our GMP system
Contract manufacturing FAQs
How is contract manufacturing different from your CDMO service?
Contract manufacturing runs a process you already own and have validated — we provide the capacity. CDMO is development work, where we build the route for a molecule from scratch. If your process is established, this is the service you want.
What is the minimum batch size for contract manufacturing?
It depends on your process and our equipment train. We confirm the minimum viable batch size during the process review, before quoting — we do not apply one blanket figure across every molecule.
Do you manufacture to our specification or yours?
Yours. We manufacture against your specification and method of analysis, and our QC releases the batch against your limits. Your documentation governs the batch, not ours.
Can you hold dedicated capacity for a repeat contract?
Yes. For standing annual contracts we schedule dedicated reactor time against your forecast so continuity of supply is planned rather than opportunistic.
Need capacity for an API you already make?
Send us the process outline and your forecast — we will come back on capacity, timing and terms.