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End-to-End Small Molecule API Solutions - Science. Scale. Speed.
Overview
At Cohance Lifesciences, we offer a unified platform for the entire lifecycle of Small Molecule API development and manufacturing. From early-phase process design to multi-ton commercial supply, we combine deep scientific rigor with operational agility – helping innovators advance their molecules with confidence. Our expertise spans complex, sensitive, and high-potency APIs, backed by robust safety assessments, regulatory compliance, and a fully backward-integrated supply chain. Whether scaling first-in-human batches or delivering commercial volumes, our seamless integration between development and manufacturing ensures quality, speed, and reliability at every stage.
Why Partner with Cohance for Small Molecule APIs?
Why Partner with Cohance for Small Molecule APIs?
- 100+ scientists dedicated to small molecule R&D
- 20+ reaction classes mastered, including hydrogenation, cyanation, and stereoselective synthesis
- Advanced flow chemistry expertise: PFRs, photo flow, CSTRs
- 200+ global DMFs filed with strong regulatory track record
- Fully backward-integrated supply chain for delivery assurance
- Multi-site GMP manufacturing network with global approvals
Manufacturing Strengths
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 Integrated 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.
Route scouting, process development, and optimization
Analytical development, impurity profiling, and validation
Comprehensive process safety assessments for secure scale-up
GMP manufacturing accredited by USFDA, EMA, and PFDA
Advanced platforms for flow chemistry, cryogenics, hazardous reactions, and high-pressure synthesis
Lifecycle support for reprocessing, impurity management, and solvent recovery
Route scouting, process development, and optimization
Analytical development, impurity profiling, and validation
Comprehensive process safety assessments for secure scale-up
GMP manufacturing accredited by USFDA, EMA, and PFDA
Advanced platforms for flow chemistry, cryogenics, hazardous reactions, and high-pressure synthesis
Lifecycle support for reprocessing, impurity management, and solvent recovery
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
Early Phase Development
Lab-scale feasibility, synthetic optimization, and impurity identification.
Scale-Up Readiness
Execution of engineering and validation batches using advanced reactors and process tools.
Lifecycle Services
Rework/reprocessing studies, solvent recovery, impurity fate, and purge investigations.
Special Capabilities
Expertise in hazardous reactions, air-/moisture-sensitive chemistries, stereoselective synthesis, and green catalysis.
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.
Facilities
We operate a robust network of cutting-edge small molecule development and manufacturing facilities across India. Our infrastructure spans lab-scale discovery to large-scale commercial manufacturing — enabling faster, flexible, and scalable solutions for your drug development needs.
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 early-stage R&D and kilo labs are designed to support route scouting, process development, and scale-up studies.
Designed to seamlessly scale from clinical to commercial manufacturing, these facilities are compliant with global regulatory standards including the US FDA.
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
Let’s advance your small molecule API from lab to market - with precision, speed, and scalability.
Contact UsResources
- Webinar: Designing Safe and Scalable API Processes
- Case Study: End-to-End Acceleration of a High-Potency API
- Whitepaper: Flow Chemistry in Small Molecule API Manufacturing
- Blog: Regulatory Readiness in Global API Supply
Resource Highlights
Webinars
Navigating Regulatory Audits in Small Molecule Manufacturing
Whitepapers
Smart Scale-Up Using Flow Chemistry
Case Studies
Seamless Tech Transfer of a Multi-Step Synthesis
Blog
Building Sustainable API Supply Chains
Webinars
Navigating Regulatory Audits in Small Molecule Manufacturing
Whitepapers
Smart Scale-Up Using Flow Chemistry
Case Studies
Seamless Tech Transfer of a Multi-Step Synthesis
Blog
Building Sustainable API Supply Chains
Our Global Accreditations
At Cohance Lifesciences, every facility stands as a testament to our commitment to uncompromised quality. Below is a snapshot of regulatory approvals and certifications across our global network
API Manufacturing Facilities
API Unit I
• US FDA, EU, PMDA, Russia MOH, KFDA, COFEPRIS, CDSCO, DCA, WHO GMP
API Unit II
• EU, DCA
API Unit III
• US FDA, EDQM, PMDA, KFDA, ANVISA, COFEPRIS, CDSCO, DCA
API Unit IV
• US FDA, EU, CDSCO, DCA
API Unit V
• ISO, DCA
Formulation (FDF) Facilities
FDF Unit I
• US FDA, Health Canada, MHRA, ANVISA, COFEPRIS, Russia MOH, TGA, Philippines FDA, Tanzania FDA, Greece NOM, Uganda NDA, Germany, SFDA, CDSCO, DCA
FDF Unit II
• CDSCO, DCA
Clinical Research
CR Bio
• US FDA, DCGI, MOH Turkey, BPFK Malaysia, WHO Geneva, MHRA, GCC, NPRA Malaysia
Suven Pharma Sites
Unit 1 to Unit 4, and Unit 6
• British Safety Council, International Safety
• ISO 20400:2017, ISO 22301:2019, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 50001:2018
Unit 5
• US FDA, DCA, PPD Global Quality Compliance, EU, CDSCO
• ISO 22301:2019, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 50001:2018
Casper
• US FDA, DCA
Our ESG Aspirations
Cohance is committed to a sustainable future with ambitious goals:
- Net-Zero Emissions by 2050: Focusing on decarbonization, renewable energy, and resource efficiency, aligned with Science-Based Targets (SBTi).
- Environmental Sustainability: Enhancing green practices through sustainable procurement and biodiversity protection.
- Social Impact: Expanding community engagement in health, sanitation, and water access, while supporting economic development through CSR initiatives.
- UN SDG Alignment: Contributing to goals like Good Health and Well-Being, Clean Water and Sanitation, and Responsible Consumption and Production.
- Ethical Governance: Strengthening transparency, ethics, and responsible sourcing through global initiatives like the Pharmaceutical Supply Chain Initiative (PSCI).
At Cohance, ESG is our promise to go above and beyond, shaping a sustainable future for health science through passion, expertise, and unwavering responsibility.
History
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Experience
Our great team of more than 1400 software experts.
Quick Support
We’ll help you test bold new ideas while sharing your.
Leadership Team
John Smith
CEO
Emma London
Co-Founder
Jessica Brown
Managing Director
Christine Eve
Designer
Sustainability
ESG
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EHS
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Quality & Compliance
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We deal With The Aspects Of Professional IT Services
About usEngitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,
Experience
Our great team of more than 1400 software experts.
Quick Support
We’ll help you test bold new ideas while sharing your.
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We deal With The Aspects Of Professional IT Services
About usEngitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,
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