Nucleosides & Phosphoramidites Development & Manufacturing

Nucleosides & Phosphoramidites Development

Precision Development for Advanced Products for Oligonucleotide Therapeutics From concept to IND-tailored chemistry, scalable support.

Overview

Sapala Organics, backed by Cohance Lifesciences, offers end-to-end development support for nucleic acid-based therapeutics, from route scouting to IND-enabling synthesis. With deep expertise in phosphoramidite chemistry and nucleoside modification, we help innovators optimize molecular design and synthesis. Our integrated approach ensures speed, scalability, and regulatory alignment from lab to manufacturing floor.

Key Highlights

Infrastructure

2 multipurpose production blocks and 1 dedicated hydrogenation block

Capacity

750 KL with varied reactor sizes and utility configurations

Scalability

Provision to add 3 additional multipurpose blocks

Technical Capability

Expertise in 30+ complex chemistries viz. Chlorination, Cyanation, Suzuki coupling, Cryo reaction, Grignard reaction, Carbonylation etc

Commitment to Quality,
Safety & Sustainability

Every batch is governed by rigorous safety protocols and eco-friendly practices to meet global standards.

Strong Track Record with
Global Agrochemical Majors

We are trusted partners to industry leaders, enabling success through innovation and reliable delivery.

Genome Valley R&D Center

25,000 sq. ft. of dedicated process development and safety labs.

Commercial Manufacturing Sites

Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.

Flow Chemistry Suites

Plug flow reactors, Corning G1 systems, and photo flow platforms.

Why Cohance for Small Molecule Manufacturing?

Why Choose Sapala for Nucleic Acid Development?

India’s only CDMO dedicated to nucleic acid chemistry
End-to-end integration with scale-up and GMP manufacturing
Collaborative, client-centric approach to synthesize complex nucleic acids for Oligo and mRNA synthesis
Proven support for discovery-to-IND transitions
Integrated collaboration with GMP manufacturing units
Agile engagement model tailored to complex nucleic acid challenges

Why Choose Cohance for Agrochemical CDMO Services?

We offer end-to-end solutions across the agrochemical lifecycle-from R&D to commercialization-ensuring reliable, scalable, and cost-efficient support tailored to your needs.

Global Regulatory
Expertise

We bring in-depth knowledge of REACH, EPA, and global certifications—ensuring smooth compliance and market entry.

Advanced R&D and
Scale-Up Capabilities

Our R&D labs excel in route scouting, process development, and scaling complex agrochemical molecules efficiently.

Integrated Supply Chain
for Cost & Time Gains

From synthesis to delivery, our end-to-end integration ensures speed, quality, and cost optimization.

Commitment to Quality,
Safety & Sustainability

Every batch is governed by rigorous safety protocols and eco-friendly practices to meet global standards.

Strong Track Record with
Global Agrochemical Majors

We are trusted partners to industry leaders, enabling success through innovation and reliable delivery.

Genome Valley R&D Center

25,000 sq. ft. of dedicated process development and safety labs.

Commercial Manufacturing Sites

Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.

Flow Chemistry Suites

Plug flow reactors, Corning G1 systems, and photo flow platforms.

Manufacturing Strengths

Scalable Production: Flexible volumes from gram to multi-ton capacity across multiple sites.

GMP-Ready Infrastructure: USFDA-, EMA-, and PMDA-approved sites with validated processes and full traceability.

Technology-Enabled Execution: Flow reactors, high-pressure systems (up to 20 kg/cm²), cryogenic capabilities (-70°C), and automation.

Regulatory Compliance: 200+ DMFs filed globally; extensive experience in audits and global market readiness.

Lifecycle Manufacturing: Support for reprocessing, impurity purge, solvent recovery, and green manufacturing practices.

Our Capabilities

Scalable
Production

Flexible volumes from gram to multi-ton capacity across multiple sites.

GMP-Ready
Infrastructure

USFDA-, EMA-, and PMDA-approved sites with validated processes and full traceability.

Technology-Enabled
Execution

Flow reactors, high-pressure systems (up to 20 kg/cm²), cryogenic capabilities (-70°C), and automation.

Regulatory
Compliance

200+ DMFs filed globally; extensive experience in audits and global market readiness.

Lifecycle
Manufacturing

Support for reprocessing, impurity purge, solvent recovery, and green manufacturing practices.

30+ years of expertise in agrochemicals and specialty chemical solutions

ISO-certified (9001, 14001, 45001), cGMP-compliant R&D and manufacturing sites

Validated systems with in-house EHS teams

Process Safety
& Risk Evaluation

State-of-the-art safety studies (RC1, DSC, ARC) to ensure secure scale-up.

Regulatory
Documentation

Comprehensive support for IND, IMPD, and DMF submissions across global markets.

Core Development Capabilities

Scalable
Production

Flexible volumes from gram to multi-ton capacity across multiple sites.

GMP-Ready
Infrastructure

USFDA-, EMA-, and PMDA-approved sites with validated processes and full traceability.

Technology-Enabled
Execution

Flow reactors, high-pressure systems (up to 20 kg/cm²), cryogenic capabilities (-70°C), and automation.

Regulatory
Compliance

200+ DMFs filed globally; extensive experience in audits and global market readiness.

Lifecycle
Manufacturing

Support for reprocessing, impurity purge, solvent recovery, and green manufacturing practices.

30+ years of expertise in agrochemicals and specialty chemical solutions

ISO-certified (9001, 14001, 45001), cGMP-compliant R&D and manufacturing sites

Strategic partnerships with leading agrochemical and chemical companies

Route
Scouting

Feasibility and pathway optimization for modified nucleosides, phosamidites, and mRNA intermediates.

Custom
Synthesis

Tailored building blocks including GalNAc conjugates, NTPs, CAP reagents, and dyes.

Analytical
Development

Method development, impurity profiling, and characterization

Regulatory
Support

IND-enabling documentation and collaboration.

Process Safety
& Risk Evaluation

State-of-the-art safety studies (RC1, DSC, ARC) to ensure secure scale-up.

Regulatory
Documentation

Comprehensive support for IND, IMPD, and DMF submissions across global markets.

Facilities

Genome Valley R&D Center: 25,000 sq. ft. of dedicated process development and safety labs.

Commercial Manufacturing Sites: Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.

Flow Chemistry Suites: Plug flow reactors, Corning G1 systems, and photo flow platforms.

Integrated Development Services

Integrated CDMO services across the Oligonucleotide and mRNA lifecycle

Custom
Synthesis

Design and synthesis of proprietary and modified nucleic acid building blocks—including high-purity phosphoramidites, NTPs, and CAP reagents—tailored to client-specific needs.

Contract Development
& Manufacturing

Scalable process development from milligram to multi-kilogram quantities. Both non-GMP and GMP execution are carried out under Cohance’s validated quality systems and aligned with global regulatory standards.

FTE Engagement
Models

In-house analytical labs with advanced instrumentation and characterization capabilities for data-driven development.

Process Safety
& Compliance

Hazard assessment studies and regulatory support aligned with REACH, EPA, and other global standards.

Integrated Supply Chain
& Lifecycle Management

Cost-optimized logistics, inventory support, and environmentally responsible process management.

Genome Valley R&D Center

25,000 sq. ft. of dedicated process development and safety labs.

Commercial Manufacturing Sites

Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.

Flow Chemistry Suites

Plug flow reactors, Corning G1 systems, and photo flow platforms.

Specialized Products

Amidites &
Nucleosides

Modified chemistries including locked/bridged nucleic acids, FANA, morpholinos, tri-cyclo DNA

GalNAc
Conjugates

PEG linkers, lipid conjugates, and sugar derivatives for drug delivery

mRNA Building
Blocks

N1-Me-pseudouridine and CAP reagents produced at multi-kg scale

Fluorescent
Dyes

Large-scale synthesis of Cy dyes, TAMRA, 6-FAM, and others

Nucleosides & Phosphoramidites Manufacturing

Scalable GMP Manufacturing for Oligo Building Blocks

Overview

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?

Integrated CDMO services across the Oligonucleotide and mRNA lifecycle

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

Process Safety
& Compliance

Hazard assessment studies and regulatory support aligned with REACH, EPA, and other global standards.

Integrated Supply Chain
& Lifecycle Management

Cost-optimized logistics, inventory support, and environmentally responsible process management.

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

Integrated CDMO services across the Oligonucleotide and mRNA lifecycle

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

Process Safety
& Compliance

Hazard assessment studies and regulatory support aligned with REACH, EPA, and other global standards.

Integrated Supply Chain
& Lifecycle Management

Cost-optimized logistics, inventory support, and environmentally responsible process management.

Dedicated Phosphoramidite - GMP (Nacharam)

1 +

Annual
capacity

ISO Class Cleanroom
& Intermediate Area

< 1 %

RH with terminal
HEPA filtration

1 Units

Plant Reactors
50L - 1,000L

1 Units

Kilo Lab Reactors
10L - 50L

Manufacturing Sites

USFDA/EDQM Accredited Sites

0 + KL

Reactor Capacity

Facilities

We operate a versatile network of specialty chemicals (Spec Chem) R&D and manufacturing facilities across India. Our infrastructure is tailored to support the development and commercial production of high-value intermediates and performance chemicals — with agility, scalability, and compliance at its core.

Genome Valley R&D Center

25,000 sq. ft. of dedicated process development and safety labs.

Commercial Manufacturing Sites

Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.

Flow Chemistry Suites

Plug flow reactors, Corning G1 systems, and photo flow platforms.

Our Spec Chem labs are optimized for process development, hazard evaluation, and scale-up readiness of specialized chemical intermediates.

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)

Genome Valley R&D Center

25,000 sq. ft. of dedicated process development and safety labs.

Commercial Manufacturing Sites

Multi-ton capacity, including facilities for HPAPIs, phosphoramidites, and other complex chemistries.

Flow Chemistry Suites

Plug flow reactors, Corning G1 systems, and photo flow platforms.

From grams to tons-trust Cohance to deliver your small molecule at scale.

Contact Manufacturing Team

Looking to scale your oligonucleotide program with high-purity building blocks and GMP assurance?

Contact Us

Resources

Webinar: Advancing Agrochemical Solutions for a Sustainable Future
Case Study: Innovative Agrochemical Product Development — From Concept to Market
Whitepaper: Optimizing Process Scale-Up in Agrochemical CDMO Operations
Blog: How Integrated CDMO Models Accelerate Agrochemical Time-to-Market

Have Any Questions?

Nucleosides & Phosphoramidites Development & Manufacturing