API CDMO / Custom Synthesis
API CDMO Services in India — Custom Synthesis & Process Development
Apex Pharma API works as a Contract Development and Manufacturing Organization (CDMO) for buyers who do not yet have a validated, production-ready process — a target molecule, a literature route, or an existing process that needs re-development for a new scale or specification. This page covers what that engagement looks like end to end, from first feasibility study to commercial handoff.
The basics
What is an API CDMO?
A CDMO develops the manufacturing process for an Active Pharmaceutical Ingredient and then manufactures it, as opposed to a Contract Manufacturing Organization (CMO), which manufactures to a specification the client already has. If you have a target molecule but no proven, scalable route to it — or a process that has only ever worked at lab scale — a CDMO relationship is what closes that gap. If your process is already validated and you just need production capacity, see our Contract Manufacturing service instead.
Signs you need a CDMO, not a straight manufacturing order
Your molecule does not appear in any manufacturer’s standard catalogue, and no validated process exists to transfer.
You have a literature reference or a patent route that has never been run at production scale.
Your existing process works in the lab but has not been optimized or validated for commercial-scale manufacturing.
You need a modified synthetic route to work around cost, supply-chain or intellectual-property constraints on the original process.
The engagement
How a CDMO project runs — stage by stage
Where more than one viable synthetic route exists to the target molecule, feasibility work compares candidate routes on yield, raw-material cost and availability, number of synthetic steps, and scalability — not simply the first route found in the literature.
The selected route is run at small scale to confirm it produces the target compound at acceptable purity and yield, before any investment is made in scaling it up.
Reaction conditions, solvent selection and purification steps are refined to improve yield, reduce raw-material cost, and remove steps that do not scale cleanly or that generate difficult impurities or waste streams.
The optimized process moves through progressively larger batches — lab, then pilot, then production scale — to surface and resolve issues that do not appear at small scale, such as heat transfer, mixing efficiency and filtration time, before committing to full commercial runs.
Test methods to confirm identity, assay and impurity profile are developed and validated in parallel with the synthetic process — a process without a matching validated analytical method is not ready for GMP manufacturing.
Once the process and its analytical methods are proven and validated, the full package is formally transferred into GMP-compliant commercial production — full documentation handoff, gap analysis against production-scale equipment, and an engineering or trial batch before commercial-scale runs begin.
This describes the general CDMO development pathway; the exact stages run in-house versus scoped per project are confirmed at project review.
Why one partner
Developed and manufactured under one quality system
A key advantage of a genuine CDMO relationship — as opposed to splitting development and manufacturing between two separate vendors — is that the process is developed with the receiving GMP facility's actual equipment and constraints in mind from the first stage onward, rather than being optimized in a lab and then found to be unworkable at the manufacturing site. This reduces the risk of a costly re-development cycle at tech-transfer stage.
Development and manufacturing sit under one quality system, GMP- and GLP-certified by the Gujarat FDCA, with an ISO 9001:2015 quality management system and MSME ZED Bronze certification. Work is handled under NDA from the first technical conversation. Full certification detail is on our Quality & Certifications page.
What to discuss before starting a CDMO project
Route information, process parameters and any analytical methods developed are covered under a signed NDA before detailed technical discussion begins.
Development work carries an inherently less predictable timeline than straight manufacturing — ask for milestone-based estimates rather than a single fixed delivery date.
Development is typically priced separately from commercial manufacturing; understand what is included in each phase (feasibility study, scale-up batches, analytical method validation) before committing.
A route that does not perform on the first pass is a normal, expected part of development — agree how re-scoping is handled contractually.
Current scope
Molecules we currently manufacture
See our full product range for the eight APIs currently in standard production: Pregabalin, Metaxalone, Flupirtine Maleate, Fenofibrate, Metadoxine, Itopride Hydrochloride, Flunixin Meglumine, Lacosamide. If your CDMO project relates to a new molecule outside this range, our team can discuss feasibility directly.
Not sure?
Which service do you actually need?
Still unsure? Read CDMO vs. CMO: what's the real difference →
CDMO & custom synthesis FAQs
What's the difference between a CDMO and a CMO?
A CDMO develops the manufacturing process before running it; a CMO manufactures to a specification you already have.
Do you handle HPAPI (highly potent API) development or manufacturing?
Highly potent API handling is a specialised capability we confirm on a per-enquiry basis — share your molecule and containment requirements and we will tell you directly whether we can take it on, rather than imply a capability we cannot evidence.
How long does a typical CDMO project take, from first enquiry to commercial batch?
It depends heavily on molecule complexity and how many candidate routes are evaluated during feasibility — we give a project-specific estimate at consultation rather than assuming a fixed timeline.
Do you file a DMF or equivalent regulatory dossier as part of a CDMO engagement?
DMF support can form part of a CDMO project and is confirmed per molecule and target market. A DMF is already on file for our Pregabalin API (IP/BP/USP).
What happens if the feasibility study does not produce a viable route on the first attempt?
This is a normal part of development work, not a failure of the engagement — the scope typically allows for route re-evaluation, and we agree how this is handled contractually before starting.
Do I need to sign an NDA before sharing my target molecule or proposed route?
Yes — we work under a signed NDA before any detailed technical discussion, and offer one without being asked.
Is my process information kept confidential from other clients?
Yes. Your molecule, route and the data developed are handled under NDA, are never shared with other clients, and are never added to our own catalogue.
Can you scale up a process I have only run at lab scale myself?
Scale-up from lab through pilot to commercial scale is part of a CDMO engagement; the achievable scale range for your specific molecule is confirmed at consultation.
What is the minimum project size for a CDMO engagement?
It is scoped per project — share your molecule, target scale and timeline and we will confirm.
Do you provide analytical method development and validation as part of the project, or only synthesis?
Analytical method development and validation run in parallel with the synthetic process as part of the standard development pathway; the exact scope for your project is confirmed at consultation.
Have a molecule that needs development, not off-the-shelf sourcing?
Tell us the target, the market and the scale — under NDA — and we will come back with a development approach.