Key Highlights

1
Infrastructure
1
Capacity
1
Scalability
1
Technical Capability
0
Manufacturing Sites
0
USFDA/EDQM Accredited Sites
0 + KL
Reactor Capacity

Purpose-Built APIs. Proven Science. Trusted Partnerships.

Overview

At Cohance, APIs are more than just products. They’re precision-crafted innovations. We combine deep scientific expertise with global regulatory alignment to develop and manufacture high-quality Active Pharmaceutical Ingredients.

With XX+ APIs in our pipeline, we partner across every stage — from development to scale-up and commercial delivery — driven by our commitment to chemistry leadership and operational excellence.

 

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 Cohance for APIs?

  • Broad end-to-end API capabilities across multiple therapeutic areas.
  • Expertise in both NCEs and generics — supporting innovator pipelines and commercial launches.
  • Proven ability to handle complex molecules, multi-step synthesis, chiral chemistry, HPAPIs, and intermediates.
  • Multi-site manufacturing advantage with FDA, EU-GMP, and other global accreditations – ensuring capacity, continuity, and flexibility.
  • Scalable production from gram-level development to multi-ton commercial manufacturing.
  • Strong global regulatory track record with extensive DMF filings and smooth inspection history.
  • Trusted partner to Big Pharma, biotech, and specialty players with a track record of long-standing customer relationships.

API Products

Product USDMF CEP EDMF China DMF CADIFA Brazil KDMF Russia Others Therapeutic Use
Aripiprazole * * * * JDMF Antipsychotic/Antidepressant
Articaine HcI * * Dental Anesthetic
Atomoxetine HcI * TDMF, Canada Attention Deficit Hyperactivity Disorder (ADHD)
Baclofen * * * * * JDMF Skeletal Muscle Relaxant
Betahistine DiHcl * AntiVertigo
Brivudine Depending upon customer interest filing can be done Antiviral
Dapagliflozin propanediol monohydrate Antidiabetic
Dexmethylphenidate HcI Tech Pack Attention Deficit Hyperactivity Disorder (ADHD)
Diflunisal * NSAID
Dipyridamole * * TGA AntiPlatelet
Doxazosin Mesylate * Antihypertensive
Drotaverine Hcl AntiSpasmodic
Entacapone * * TDMF, *JDMF AntiParkinson
Flurbiprofen * * JDMF NSAID
Fluvoxamine Maleate * * * * * TDMF Antidepressant
Hydralazine HcI * * * JDMF Antihypertensive
Irinotecan Hcl Anti-Cancer
Lamotrigine * * * JDMF Antiepileptic
Lenalidomide (Form-A,Form-I,Form-B) * * * * * * * * JDMF Anti-Cancer
Levocetirizine DiHcl TDMF AntiHistamine
Levomepromazine Maleate * Antipsychotic
Maraviroc TDMF Antiretroviral
Mebeverine * * * TGA, TDMF AntiSpasmodic
Meclizine HcI AntiHistamine
Methotrexate Anti-Cancer
Methylphenidate HcI * Attention Deficit Hyperactivity Disorder (ADHD)
Midazolam * TDMF Anesthetic
Midazolam HcI Anesthetic
Midazolam Maleate Anesthetic
Pirfenidone * * AntiInflammatory / AntiRheumatic
Posaconazole * * * * * * JDMF Antifungal
Propiomazine Maleate Antipsychotic
Quetiapine Fumarate * TGA Antipsychotic
Ractopamine HcI Canada β Adrenergic Agonist(V)
Rivaroxaban * * * JDMF Anticoagulant
Tamsulosin HcI * TDMF Benign Prostatic Hyperplasia
Tapentadol Phosphate Anesthetic
Tolcapone AntiParkinson
Venlafaxine HcI * * * * * JDMF Antidepressant
Verapamil HcI * Antihypertensive
Zonisamide TDMF, JDMF Anticonvulsant
Zonisamide Anticonvulsant
Bempedoic Acid * Antilipemic agent
Cannabidiol * Analgesic, Anticonvulsant, Muscle relaxant, Anxiolytic, Antipsychotic
Product Therapeutic Use Status
Benserazide Anti-Parkinsons Process validation Completed
Lisdexamfetamine dimesylate Attention deficit Hyperactivity disorder (ADHD) treatment, Antidepressant, Schizophrenia treatment Process validation Completed
Dabigatran Antithrombotic Under process validation
Cilostazol Antithrombotic, Vasodilator Process validation Completed
Desvenlafaxine Antidepressant, Anxiolytic Development Completed. Process validation to start
Oxymetazoline Decongestant, Vasoconstrictor Under process validation
Remimazolam Local anesthetics, Sedative Under process validation
Loxoprofen Analgesic, Anti-inflammatory Under process validation
Levodropropizine Antitussive, Cough suppressant Under process validation
Trimetazidine Anti-anginal Under process validation
Irinotecan Hydrochloride Oncology Development Completed. Process validation to start
Lenalidomide Form-A Oncology Development Completed. Process validation to start
Lenalidomide Form-B Oncology Development Completed. Process validation to start
Methotrexate Oncology Feasibility stage
Product USDMF CEP EDMF China DMF CADIFA Brazil KDMF Russia Others Therapeutic Use
Aripiprazole * * * * JDMF Antipsychotic/Antidepressant
Articaine HcI * * Dental Anesthetic
Atomoxetine HcI * TDMF, Canada Attention Deficit Hyperactivity Disorder (ADHD)
Baclofen * * * * * JDMF Skeletal Muscle Relaxant
Betahistine DiHcl * AntiVertigo
Brivudine Depending upon customer interest filing can be done Antiviral
Dapagliflozin propanediol monohydrate Antidiabetic
Dexmethylphenidate HcI Tech Pack Attention Deficit Hyperactivity Disorder (ADHD)

Show More

Product Therapeutic Use Status
Benserazide Anti-Parkinsons Process validation Completed
Lisdexamfetamine dimesylate Attention deficit Hyperactivity disorder (ADHD) treatment, Antidepressant, Schizophrenia treatment Process validation Completed
Dabigatran Antithrombotic Under process validation
Cilostazol Antithrombotic, Vasodilator Process validation Completed
Desvenlafaxine Antidepressant, Anxiolytic Development Completed. Process validation to start
Oxymetazoline Decongestant, Vasoconstrictor Under process validation
Remimazolam Local anesthetics, Sedative Under process validation
Loxoprofen Analgesic, Anti-inflammatory Under process validation

Show 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 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

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

Validated systems with in-house EHS teams

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.

API Manufacturing Highlights

Strong API
Portfolio

100+ commercial APIs across CVS, CNS, anti-infectives, anti-diabetics, GI, pain management & more.
Pipeline APIs under development for regulated & semi-regulated markets. Expertise across both Generics & NCE APIs.

Strong Process
Chemistry Expertise

Complex multi-step synthesis, asymmetric synthesis, chiral chemistry.
HPAPI handling (dedicated suites), controlled substances, peptides & intermediates. Robust QbD-based process development.

Integrated R&D
and Manufacturing

In-house process development integrated with manufacturing.
Seamless scale-up & tech transfer. Process optimization: cost, yield, cycle time & impurity profile control.

Multiple World-Class
Manufacturing Facilities

5+ API manufacturing sites across India. Accredited by USFDA, EU-GMP, WHO-GMP, PMDA-Japan, ANVISA-Brazil.
Strong regulatory inspection track record.

Flexible
Production Scales

Lab to commercial scale: grams to hundreds of tons annually.
Multi-purpose plants enabling rapid campaign changeovers.

Regulatory
Documentation Strength

Extensive DMF filings (US, Canada, CEP-EDQM, RoW).
Experienced global regulatory affairs team.

Dedicated HPAPI
Manufacturing

Separate facilities & advanced containment. OEL < 1 μg/m³ handling capability.
Specialized safety & cross-contamination prevention controls.

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
Validated systems with in-house EHS teams
Recognized for sustainable manufacturing practices
Proven track record in process innovation and scale-up
Leader in cost optimization and efficient procurement strategies
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.

Our 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.

Custom Development
& Manufacturing

Full-spectrum development and manufacturing of active ingredients (AIs) and specialty formulations to your specifications.

Advanced Synthesis
& Scale-Up

Route scouting, process optimization, and seamless transition from kilo-lab to commercial scale — backed by flow chemistry, high-pressure systems, and a 50+ reaction-type toolbox.

Analytical &
Validation Support

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.

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.

API+ Facilities

We operate a highly specialized network of API development and manufacturing facilities across India. Our API+ infrastructure is purpose-built to handle complex chemistries, advanced process development, and scalable commercial manufacturing – enabling reliable, flexible, and accelerated delivery of high-quality APIs for our global customers.

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 focus on complex molecule development, multi-step synthesis, and scale-up feasibility studies.

Equipped with state-of-the-art infrastructure and robust quality systems, our commercial API facilities enable seamless scale-up from lab to global market supply. (~3,000+ kL Capacity) – ⭐ denotes US FDA-audited sites.

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

Your API deserves more than a manufacturer. It deserves a partner.

Resources

  • Webinar: Chemistry that Delivers – APIs in a Post-Pandemic World
  • Whitepaper: Rethinking CDMO Partnerships for API Security & Innovation
  • Infographic: API Lifecycle Support – From Molecule to Market

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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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,

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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440
employees from around the world
+ 640
happy clients from largest corporations
+ 0
offices in 6 counties worldwide

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,

UI/UX Design
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App Development
82%
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Science & Technology

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