Contract Research & Manufacturing
(CRAMS / CDMO)
Lab to pilot to commercial manufacturing under one roof — GMP and non-GMP facilities, 250L and 500L pilot units.
CRAMS (Contract Research and Manufacturing Services) and CDMO (Contract Development and Manufacturing Organization) work at Sparge Chem covers the full span from early process research through GMP-certified production — lab, pilot, and commercial-scale manufacturing under one roof, rather than research done in-house and manufacturing subcontracted elsewhere.
Founded in 2017 by Dr. Ravindra Pal and Ankush Sarde at Bhosari MIDC, Pune, and grown from a 2,000 sq. ft. lab to a 5,000 sq. ft. facility. The GMP facility runs alongside a separate non-GMP facility, so early development work and later regulatory-grade production don't compete for the same equipment or compromise on quality-system separation.
This is the same infrastructure behind our custom synthesis, medicinal chemistry, process development, and building-block work — a CRAMS/CDMO engagement typically draws on all four, run as one continuous program from a research question to a delivered batch, under a single NDA.
What's included
GMP-certified manufacturing
A dedicated GMP facility for regulatory-grade production runs, separate from the non-GMP development facility.
Pilot-to-commercial scale-up
250L and 500L pilot units (plus 100L for earlier-stage work) bridge lab-scale process development and commercial-scale manufacturing.
Full program management
Research, process development, and manufacturing run as one program under one NDA — not separate vendor relationships stitched together.
Analytical & quality support
In-house HPLC/LCMS and NMR-backed characterization at every stage, with Certificates of Analysis issued against production batches.
Flexible engagement scope
From a single manufacturing run against an already-developed process, to a full research-through-manufacturing program built from scratch.
How it works
Scope the program
Define whether the engagement starts from research (a target with no existing route), development (a route that needs scale-up), or manufacturing (an already-validated process needing production runs).
NDA & feasibility
NDA executed first; feasibility and timeline assessment follows within 24 hours for the research/development stages.
Development & pilot scale-up
Route development and scale-up through 100L–500L pilot units, in the non-GMP facility.
GMP production
Validated process transitions to the GMP facility for commercial-scale manufacturing runs.
Delivery & documentation
Batches ship with full analytical documentation and Certificates of Analysis.
Track record
600 kg GMP production, 99.5%+ purity
Letermovir intermediate manufactured at 600 kg scale in our GMP facility (99.5%+ purity), with a parallel 50 kg non-GMP track — direct evidence of the CRAMS/CDMO capability, not a separate case study.
Multi-molecule process portfolio
Process development and manufacturing support spanning quinoline derivative intermediates, Zavegepant, and Bemnifosbuvir intermediates — a track record across several distinct chemistries, not one.
Common questions
What's the difference between your CRAMS/CDMO offering and your process development service?
Process development is one piece of a CRAMS/CDMO engagement — CRAMS/CDMO covers the full span from research through GMP manufacturing, run as one program. You can also engage process development alone if manufacturing isn't yet in scope.
Is your manufacturing facility GMP certified?
We operate a dedicated GMP facility for production runs, run separately from our non-GMP development facility — our largest GMP production run to date is 600 kg at 99.5%+ purity.
Can you take on a program that starts from a target with no existing route?
Yes — a CRAMS/CDMO engagement can start from research (route scouting and development) through to commercial-scale manufacturing, under one NDA.
What pilot and production scales are available?
100L, 250L, and 500L pilot units for development and scale-up, feeding into GMP production runs — 600 kg is the largest single production run completed to date.
Ready to discuss crams / cdmo?
NDA before any technical discussion. 24-hour feasibility response.