Small Molecule API Development

Cohance :Small Molecule API :Small Molecule API Development

Powering Your Pipeline with Science and Speed

Overview

At Cohance Lifesciences, we bring scientific rigor and operational agility to the development of small molecule APIs, advanced intermediates and starting materials. Our end-to-end capabilities span route scouting, process optimization, analytical development, and regulatory documentation—empowering innovators to move confidently from concept to clinic.

With deep expertise across hazardous, moisture-sensitive, and stereoselective chemistries, our dedicated process R&D teams engineer robust, scalable, and cost-effective synthesis pathways. Every step is underpinned by integrated process safety, data integrity, and global compliance, ensuring a smooth transition to GMP manufacturing and regulatory submissions.

 
Small Molecule API Development Page

Why Cohance for Small Molecule Development?

Why Cohance for Small Molecule Development

Why Cohance for Small Molecule Development?

  • 100+ scientists dedicated to small molecule R&D
  • Experience in 20+ reaction classes (e.g., hydrogenation, cyanation, cryogenics)
  • Flow chemistry excellence: PFRs, photo flow, CSTRs
  • Integrated safety studies and scalability assessment
  • Fully equipped R&D facility at Genome Valley, Hyderabad

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.

Featured Services

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

Efficient identification of optimal synthetic routes using DoE and feasibility studies.

Process Development
& Optimization

Risk-informed development, impurity profiling, and scalable optimization for cost and purity.

Analytical
Development

Custom methods, impurity markers, validation, and stability-indicating assays.

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 more.

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.

Genome Valley, Hyderabad

Nacharam, Hyderabad (Oligo CoE)

Nacharam, Hyderabad (Oligo CoE)

Designed to seamlessly scale from clinical to commercial manufacturing, these facilities are compliant with global regulatory standards including the US FDA.

Suryapet, Telangana

Jeedimetla, Hyderabad

Pashamylaram, Hyderabad

Vizag, Andhra Pradesh

Nacharam, Hyderabad

Nacharam, Hyderabad

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

Ready to co-develop your next breakthrough molecule?

Contact Us

Resources

  • Webinar: De-Risking Early-Phase API Development
  • Case Study: Accelerated Scale-Up of a Chiral Intermediate
  • Whitepaper: Green Chemistry in Route Optimization
  • Blog: The Role of Analytical Precision in Small Molecule Success

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

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

CR Bio
• US FDA, DCGI, MOH Turkey, BPFK Malaysia, WHO Geneva, MHRA, GCC, NPRA Malaysia

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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About us

Engitech 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 us

Engitech 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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