Scalable GMP Manufacturing for Oligo Building Blocks
Backed by Cohance Lifesciences, Sapala Organics delivers GMP-compliant manufacturing of oligonucleotide intermediates at scale. Our infrastructure includes dedicated amidite blocks, ISO-grade cleanrooms, and versatile reactors to support GalNAc compounds, modified nucleosides, mRNA reagents, and fluorescent dyes. With capacity from 100 g to 100+ kg, we support clinical and commercial supply with validated processes and global regulatory alignment.
Why Cohance + Sapala for Oligonucleotide Manufacturing?
Only Indian CDMO with deep nucleic acid scale-up capabilities
Only Indian CDMO with dedicated infrastructure for oligonucleotide intermediates
Proven GMP compliance
Audit-ready, globally aligned documentation
Flexible delivery—from 100 g R&D batches to 100+ kg GMP lots
Proven execution across GalNAc, fluorescent dyes, and mRNA reagents
Process rigor supported by validated SOPs, batch traceability, and regulatory readiness
Backed by Cohance Lifesciences’ global compliance framework
Custom-Fit Execution Models
Integrated CDMO
Manufacturing
Comprehensive services from late-stage development to GMP batch production, ensuring regulatory-aligned manufacturing.
Flexible Delivery
& Engagement
Choose from fixed-scope or FTE-based models to match your scale, timelines, and internal capabilities.
End-to-End
Accountability
Combined expertise in complex synthesis and rigorous manufacturing makes Sapala a seamless CDMO partner from development to commercial readiness.
Manufacturing Infrastructure Highlights
600–700 kg/year Capacity at dedicated GMP amidite unit (Nacharam)
ISO Class 8 / Grade D Cleanrooms with HEPA filtration and RH control for sensitive drying and dispensing
Versatile Reactor Suite: 10+ reactors (glass, stainless steel, Hastelloy) ranging from 50 L to 1,000 L
Advanced Equipment: Lyophilizers, Nutsche filters, rotavapors, and large-volume glass columns
USFDA-Approved Unit 4 being equipped for commercial-scale GMP phosphoramidite manufacturing
Upcoming Expansion: GMP readiness by September 2025, enabling larger volume delivery for clinical and commercial needs
Dedicated Phosphoramidite - GMP (Nacharam)
1
Kgs
Annual
capacity
capacity
1
ISO Class Cleanroom
& Intermediate Area
& Intermediate Area
<
1
%
RH with terminal
HEPA filtration
HEPA filtration
1
Units
Plant Reactors
50L - 1,000L
50L - 1,000L
1
Units
Kilo Lab Reactors
10L - 50L
10L - 50L
Facilities
Sapala Organics, IDA Mallapur
Hyderabad, India
Our pilot and commercial-scale Specialty Chem facilities are engineered for multipurpose operations — enabling flexible batch production, robust scale-up, and safe manufacturing. (~3,000+ kL Capacity)
CDMO Unit-II, Jeedimetla
Hyderabad, India
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