- 24 Tech Roqad st Ny 10023
- editech@mail.com
Key Highlights
1
Infrastructure
1
Capacity
1
Scalability
1
Technical Capability
0
Manufacturing Sites
0
USFDA/EDQM Accredited Sites
0
+ KL
Reactor Capacity
Smarter Formulations. Better Patient Outcomes.
Overview
At Cohance, our integrated FDF development and manufacturing platform empowers pharma partners to bring products to market faster, smarter, and with full regulatory confidence. Whether it’s first-to-file generics or lifecycle-managed assets, our track record speaks to our ability to deliver impact where it matters.
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 FDFs?
- 50+ commercialized products across global markets
- Proven expertise in first-to-file, Para IV, and 505(b)(2) strategies
- Speed-to-market advantage backed by robust scale-up and tech transfer capabilities
- Ready-to-file dossiers across a wide range of therapeutic areas
- Proven track record in BE strategy alignment
- Built for flexibility, regulatory compliance, and delivery excellence
FDF 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 | Strength | ANDA (Approved/Filed) | EU Dossier (Approved/Filed) | ANDS (Approved/Filed) | Countries for which Dossier are available |
|---|---|---|---|---|---|
| Baclofen Tablets | 5mg | Approved | Not Filed | Except USA | |
| Baclofen Tablets | 10mg | Approved | Not Filed | Except USA | |
| Baclofen Tablets | 20mg | Approved | Not Filed | Except USA | |
| Cinacalcet tablets | 30 mg | Approved | Approved | Can be offered globally | |
| Cinacalcet tablets | 60 mg | Approved | Approved | Can be offered globally | |
| Cinacalcet tablets | 90 mg | Approved | Approved | Can be offered globally | |
| Doxazosin tablets | 1 mg | Filed | Not filed | Approved in CA | Except USA, Canada |
| Doxazosin tablets | 2 mg | Filed | Not filed | Approved in CA | Except USA, Canada |
| Product | Strength | Status |
|---|---|---|
| FERRIC CITRATE Tablets | EQ210 IRON | Proof of concept established |
| Aspirin+Dipyridamole ER Capsules | 25/200mg | Proof of concept established |
| Mexiletine Capsules | 150mg/200mg/250mg | Proof of concept established |
| Diflunisal tablets | 500 mg | Proof of concept established |
| Dipyridamole ER capsules | 200 mg | Proof of concept established |
| Solifenacin & Tamsulosin PR tablets | 6 mg/0.4 mg | Proof of concept established |
| Hydralazine HCl tablets | 10 mg, 25 mg, 50 mg and 100 mg | Proof of concept established |
| Tamsulosin MR tablets | 0.4mg | Under development |
Core Capabilities
Formulation Design
for Complex Generics
SR/ER, ODT, nano suspensions, bilayer tablets, and more.
High-Potency &
Cytotoxic Capabilities
Specialized containment suites for regulatory-grade safety.
Multiformat
Scalability
Tablets, capsules, pellets, sachets — under one roof.
Global Regulatory
Strength
ANDA, EU Dossier, ANDS filings across 50+ countries.
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.
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.
Formulation Services
From Prototype to Global Supply.
Preformulation &
Prototype Development
QbD-Based Design
& Optimization
Dossier Preparation &
Filing (ANDA, EU, ANDS)
Tech Transfer, Scale-Up,
Commercial Manufacturing
Lifecycle & Post-Approval
Variation 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.
Facilities
From lab-scale R&D to kilo-scale trials and commercial-scale production, our infrastructure for the development and manufacturing of Finished Dosage Forms (FDFs) — with a strong focus on oral solids — is designed for speed, scalability, regulatory compliance, and innovation in drug 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.
Our early-stage formulation development centers in Nacharam and Pashamylaram-R&D, Hyderabad, support formulation design, modified-release technology development, and clinical trial material manufacturing. These GMP facilities are equipped with high-containment suites and technology platforms for novel oral delivery systems and modified release formulations, operating under stringent cGMP standards.
Our commercial-scale FDF manufacturing spans 3 sites in Hyderabad. These sites are part of a robust 3,000+ kL capacity infrastructure, equipped to handle diverse formulation types and scale-up requirements. Several facilities are audited by the US FDA and cleared by key global regulatory agencies including: MHRA | EU | TGA | ANVISA | Health Canada | KFDA
Built for flexibility and regulatory rigor, these facilities enable rapid tech transfer and reliable commercial supply across therapeutic categories – with end-to-end integration ensuring operational consistency throughout the product lifecycle. (~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
Let’s co-develop the next formulation breakthrough - together.
Contact UsResources
- Webinar: Formulation Forward – Complex Generics & the Future of Drug Delivery
- Whitepaper: Accelerating Global Market Entry with Integrated FDF Services
- Infographic: Your FDF Journey with Cohance – Development to Delivery
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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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 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,
UI/UX Design
95%
App Development
82%
Business Growth
90%
Technology Solution
80%
Science & Technology
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John Smith
A leading Company
