Contract Manufacturing
API Contract Manufacturing in India — Production to Your Specification
Apex Pharma API provides contract manufacturing for buyers who already have a validated Active Pharmaceutical Ingredient specification and need a GMP-compliant partner to produce it at scale. This page covers exactly how that process runs, from specification handover to ongoing commercial supply.
The basics
What is API contract manufacturing?
Contract manufacturing means you bring a validated process, specification and analytical test methods — developed either in-house or by a previous partner — and we manufacture to it under our own GMP quality system. This is different from a CDMO relationship, where the process itself still needs to be developed; see our API CDMO & Custom Synthesis service if your molecule does not yet have a proven, scalable route.
The engagement
How a contract runs — stage by stage
You provide your existing manufacturing specification, analytical test methods and any available regulatory documentation (prior Certificates of Analysis, stability data). This is reviewed for feasibility against our equipment, capacity and regulatory scope before a quote is issued — catching mismatches early rather than after commitment.
We assess whether your specification can be run as submitted, what raw materials and intermediates are required, and where the work fits into production scheduling. Minimum order quantity, batch size and lead time are confirmed explicitly at this stage.
Your process documentation, analytical methods and specifications are formally transferred to our production and quality teams, including a gap analysis comparing your original process parameters against what is achievable on our equipment — not assumed to be a one-to-one copy without adjustment.
Before commercial-scale commitment, a trial batch — often at intermediate scale — confirms the transferred process performs as expected on our equipment. Results are compared against your original specification, and any deviations are investigated and resolved before scaling further.
Depending on your regulatory strategy and destination market, one or more validation batches may be needed to formally demonstrate the process is reproducible at commercial scale. This is typically driven by your own regulatory requirements — we support it under our quality system, and the specific validation protocol is agreed with you directly.
Commercial batches proceed against agreed schedules once validation (where applicable) is complete. Every batch ships with a Certificate of Analysis specific to that batch.
The relationship continues under a formal quality agreement covering change control — any proposed modification to the agreed process requires your sign-off — deviation handling, and re-order lead times.
Read the full step-by-step breakdown: The API Contract Manufacturing Process, Step by Step →
Quality
Your process, run under our quality system
Your specification is executed under our GMP-compliant quality system — meaning your process documentation, batch records and analytical methods are managed within our existing quality infrastructure rather than requiring you to build or audit a separate system. Manufacturing runs under GMP and GLP certificates from the Gujarat FDCA, an ISO 9001:2015 quality management system and MSME ZED Bronze certification, all under NDA.
Full current certification detail, with certificate numbers and validity, is on our Quality & Certifications page.
Current scope
Products 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 contract manufacturing need involves a different molecule, our team can discuss feasibility.
Not sure?
Which service do you actually need?
Still unsure? Read CDMO vs. CMO: what's the real difference →
Contract manufacturing FAQs
How is this different from your CDMO service?
Contract manufacturing assumes your specification is already validated and ready to transfer; a CDMO engagement starts earlier, with process development itself.
What is the minimum batch size for a contract manufacturing run?
It depends on your process and our equipment train; we confirm the minimum viable batch size during the specification and feasibility review, before quoting — we do not apply one blanket figure across every molecule.
Do you supply raw materials, or do I need to provide them?
This varies by arrangement and is agreed during the technical-feasibility stage — tell us your preference and we will confirm what works for your process.
Is a trial or engineering batch always required before commercial production?
In most contract manufacturing engagements, yes — it is the step that confirms your process performs as expected on our specific equipment before committing to full-scale runs. The exact approach is scoped per project.
How long does the process take, from spec handover to first commercial shipment?
It depends on compound complexity, whether the trial batch reveals any issues, and your validation requirements — we give a project-specific timeline rather than a general estimate.
Who owns the manufacturing IP in a contract manufacturing arrangement?
This is defined by the contract terms, not assumed by default — IP ownership and confidentiality are confirmed explicitly, under NDA, before you share your specification.
Is a Certificate of Analysis provided with every commercial batch?
Yes — a batch-wise Certificate of Analysis is issued as standard with every despatch, alongside the MSDS, specification sheet and method of analysis.
What packaging options are available for contract-manufactured batches?
Standard packing is 1 kg, 5 kg and 25 kg HDPE drums with double LDPE liners; other configurations are available on request.
How is a proposed change to my process handled once commercial production has started?
Through a formal change-control process under the quality agreement — any proposed change requires your sign-off before implementation.
Can you handle contract manufacturing for export markets with different regulatory requirements?
We can supply non-regulated export markets, with export documentation prepared in-house — share your destination market and its requirements and we will confirm what we can provide.
Have an established specification and need a manufacturing partner?
Send us the process outline and your forecast — we will come back on capacity, timing and terms.