Integrated Generic Platform offering Concept to Commercialization Solutions
Overview
At Cohance, our generic API platform offers an integrated solutions approach, uniquely positioned to serve our global customer base. With 30+ years of rich legacy, backed by deep chemistry capabilities, global regulatory expertise, and reliable supply network, we serve customers across 60+ countries, from 8 cGMP facilities, offering 50+ molecules across various therapeutic areas. We partner with leading pharma innovators and global generics, collaborating across the product lifecyle stage.
Why partner with us?
Why partner with us?
- Integrated Solutions Approach – Unified generic platform offering APIs, Pellets, and Finished Dosage Forms
- Chemistry at Core – 3 dedicated R&D centres with 150+ R&D strength
- Global Portfolio – 50+ molecules with customer base across 60+ countries
- Flexible Offerings – From Catalog to customized solutions
- Scale and Reliability – 8 cGMP sites offering kilo to multi-ton capacities
- Regulatory Compliance – Global regulatory accreditations such as USFDA, EU-GMP, ANVISA, PMDA, NPMA, Health Canada, TGA, KFDA, and more
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.
APIs
• Partner of choice offering Scale, Compliance, and Reliability
• Deep chemistry capabilities, scalable capacities, and robust regulatory track record
• 1600+ KL operational capacity across 5 cGMP facilities with global accreditations – USFDA, EDQM, PMDA, NMPA, KFDA, ANVISA, and others
• Diverse portfolio of 80+ molecules covering multiple therapeutic areas
PFIs
• Pelletized intermediates for modified-release formulations
• Strong backward integration with in-house APIs
• BE-oriented design; strong regulatory expertise to support global filings
• 830+ MT operational capacity across 2 cGMP facilities
FDFs
• Vertically integrated CMO/CDMO solutions for generic pharma
• Multi-dosage capabilities including Oral Solids, Oral Liquids, Topical Cloths, Semi-solid Topicals, and others
• 3 cGMP facilities with global regulatory accreditations (USFDA, EU-GMP, Health Canada, TGA, etc.)
• Expertise in in-house development, tech-transfer, dossier filing, and lifecycle support
APIs
• Complex chemistries, NCEs, HPAPIs, peptides
• 5+ manufacturing sites | Global DMF filings
• Extensive therapeutic area coverage
PFIs
• Pelletized intermediates for modified-release formulations
• BE-oriented design, multiparticulate expertise
• Strong backward integration with in-house APIs
FDFs
• Oral solids: tablets, capsules, sachets, bilayer, ODTs
• First-to-file & Para IV strategy expertise
• Full tech transfer, dossier filing, and lifecycle support
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.
Why Cohance for Small Molecule Manufacturing?
Purpose-Built Facilities. Global Readiness.
Across India, our specialized sites cater to the entire development and manufacturing lifecycle — spanning R&D labs, kilo-scale units, and commercial-scale infrastructure
(>3,000 kL capacity). Select facilities are USFDA-audited and cleared by key global regulators.
- Dedicated HPAPI & containment suites
- QbD-driven process & formulation development
- Oral solids focus with high-containment, novel delivery platforms
- Integrated tech transfer and regulatory documentation support
Our Integrated Capabilities
APIs
- Partner of choice offering Scale, Compliance, and Reliability
- Deep chemistry capabilities, scalable capacities, and robust regulatory track record
- 1600+ KL operational capacity across 5 cGMP facilities with global accreditations – USFDA, EDQM, PMDA, NMPA, KFDA, ANVISA, and others
- Diverse portfolio of 50+ molecules covering multiple therapeutic areas
Pellets
- Pelletized intermediates for modified-release formulations
- Strong backward integration with in-house APIs
- BE-oriented design; strong regulatory expertise to support global filings
- 830+ MT operational capacity across 2 cGMP facilities
FDFs
- Vertically integrated CMO/CDMO solutions for generic pharma
- Multi-dosage capabilities including Oral Solids, Oral Liquids, Topical Cloths, Semi-solid Topicals, and others
- 3 cGMP facilities with global regulatory accreditations (USFDA, EU-GMP, Health Canada, TGA, etc.)
- Expertise in in-house development, tech-transfer, dossier filing, and lifecycle support
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.
API R&D, Genome Valley
Hyderabad, India
API R&D, Ankaleshwar
Gujarat, India
API Unit-I, Jaggayapet
Vijayawada, India
API Unit-II, Achutapuram
Vizag, India
API Unit-III, Ankaleshwar
Gujarat, India
CDMO Unit-III, Pashamylaram
Hyderabad, India
Designed to seamlessly scale from clinical to commercial manufacturing, these facilities are compliant with global regulatory standards including the US FDA.
FDF Unit-I, Nacharam
Hyderabad, India
FDF Unit-II, Jadcherla
Hyderabad, India
Designed to seamlessly scale from clinical to commercial manufacturing, these facilities are compliant with global regulatory standards including the US FDA.
FDF Unit-I, Nacharam
Hyderabad, India
FDF Unit-II, Jadcherla
Hyderabad, India
FDF Unit-III, Pashamylaram
Hyderabad, India
FDF Unit IV, Shamshabad
Hyderabad, India
FDF R&D, Nacharam
Hyderabad, India
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 Shape the Future of Generics - Together
From ideation to commercialization, Cohance’s Generic API platform offers unmatched reliability and integrated support.
Contact UsResources
- 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
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
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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 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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