CDMO Contract Manufacturing in Pune, India
A full-service Pune CDMO — process route scouting, kilo-lab proof-of-concept, pilot-plant scale-up, registration-batch manufacture, and commercial supply under WHO-GMP. We’ve taken 40+ molecules from grams to multi-ton in the past five years.
Where we sit in your development timeline
Most CDMO engagements with us start at one of four points:
- Route scouting — you have a target molecule (proprietary or generic) but no committed synthesis route. We propose 2-3 routes with cost, yield, and impurity-profile estimates within 2-3 weeks.
- Kilo-lab POC — we make 100g to 5kg of your molecule for your tox studies, formulation development, or analytical method qualification.
- Tech transfer + scale-up — your molecule is established at a competitor’s plant; we transfer it to ours, requalify under our QMS, and supply commercially at lower cost.
- Commercial supply — your molecule has full regulatory approval; you need a qualified secondary or replacement manufacturer with capacity.
Capacity and equipment
Our Pune facility runs four GMP-compliant production blocks:
- Kilo lab — 5L, 20L, 50L reactors for early-stage scale-up.
- Pilot plant — 100L to 500L glass-lined and Hastelloy reactors for registration batches.
- Commercial Block A — 1,000L to 6,000L reactors, total batch size up to 800kg.
- Commercial Block B (peptide / SPPS) — solid-phase peptide synthesis up to 200g API per batch.
Downstream we operate centrifuges, filter dryers, agitated nutsche filter dryers (ANFD), tray dryers, jet mills, and a full analytical laboratory (HPLC, GC, NMR, MS, IR, KF, particle-size, dissolution).
Confidentiality and IP protection
CDMO work starts under a mutual NDA before any technical disclosure. For larger engagements we sign a full Master Services Agreement (MSA) that covers IP ownership, employee non-solicit, exclusivity (if you want it), and dispute resolution under Indian arbitration. Patentable IP discovered during process development defaults to the customer; we retain rights only to generic process know-how.
Explore the catalogue
Frequently asked questions
What is your minimum order quantity for custom synthesis?
Kilo-lab POC starts at 100g. Pilot scale starts at 5kg per campaign. Commercial supply starts at 50kg/year. We typically don’t take on engagements below 1kg lifetime volume.
How long does process development to commercial supply take?
A typical generic API from route-scouting to first commercial batch runs 8-14 months: 6-8 weeks route work, 8-12 weeks kilo lab, 12-16 weeks pilot + validation batches, 4-6 weeks regulatory filing prep.
Will you sign exclusivity?
Yes — we sign molecule-specific exclusivity in regulated markets (US, EU, Japan) on case-by-case basis. India remains non-exclusive by default unless covered by an upfront fee.
Do you take on tox-batch supply?
Yes. Non-GMP tox batches (1-50kg) are supported with full impurity characterisation. GLP-equivalent documentation is available where the buyer’s tox CRO requires it.
Talk to a sales engineer
First response within 4 business hours, Pune time (IST). We can also run a teams call inside your working hours — most weekday hours across the US, EU, LATAM and APAC are covered.