Key Highlights
1
Infrastructure
1
Capacity
1
Scalability
1
Technical Capability
0
Manufacturing Sites
0
USFDA/EDQM Accredited Sites
0
+ KL
Reactor Capacity
High-Performance Pellets for Solid Oral Dosage Success
Overview
At Cohance, PFIs serve as strategic enablers…driving faster development, ensuring regulatory alignment, and unlocking product differentiation. Backed by deep expertise in multiparticulate systems and robust backward integration, we deliver sustained- and controlled-release pellet intermediates designed to support your product across its lifecycle.
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 PFIs?
- One of India’s leading exporters of pellet-based PFIs with a strong global presence
- Expertise in multiparticulate systems for sustained- and controlled-release formulations
- Technology-driven customization for innovators and generics
- Regulatory-ready dossiers and submission support across key markets
- Proven track record in BE strategy alignment
- Consistent supply backed by strong backward integration
- Robust QMS and global audit readiness
- Flexible, scalable manufacturing for varied lifecycle needs
Core Capabilities
Sustained/Controlled
Release Expertise
Pellet systems optimized for drug release, taste-masking, and bioavailability.
BE-Oriented
PFI Systems
Designed with bioequivalence strategy, RLD mapping, and stability data support.
Global Regulatory
Alignment
Proven submissions across Brazil, Turkey, MENA, APAC - and growing.
Backward Integration
Advantage
Secure supply chain powered by in-house API synergy.
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.
Pellets 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 Name | DMF/Techpack | Bio equivalence established (Y/N) | Type of BE study Fast/Fed | RLD/Mkt | Stability | Brazil | Turkey | Mexico | MENA | APAC |
|---|---|---|---|---|---|---|---|---|---|---|
| Duloxetine DR Pellets 17% (HPMC Phthalate) | Techpack | No | 6M | Yes | ||||||
| Duloxetine HCl DR Pellets 20% (HPMC Acetyl succinate) | DMF | Yes | Fast & Fed | CYMBALTA/EU | 36M | Yes | Yes | |||
| Duloxetine HCl DR Pellets 20% (HPMC Phthalate) | DMF | Yes | Fast & Fed | CYMBALTA/EU | 36M | Yes | Yes | |||
| Fenofibrate SR Pellets 75% | DMF | No | 36M | Yes | Yes | |||||
| Fenofibric acid DR Pellets 29% | DMF | No | 6M | Yes | Yes | |||||
| Itraconazole IR Pellets 21.74% | DMF | Yes | Fast & Fed | SPORANOX/US | 24M | Yes | ||||
| Itraconazole IR Pellets 22% | DMF | No | 36M | Yes | Yes | Yes | ||||
| Lansoprazole Pellets 8.5% | DMF | No * | * Customer established BE in TR | 36M | Yes | Yes | Yes |
| Product Name | DMF/ Techpack | Bio equivalence will be available by | Type of BE study Fast/Fed | RLD/Mkt | Stability |
|---|---|---|---|---|---|
| Posaconazole DR granules 16.39% (Direct compressable) | DMF | Available | Fast & Fed | Noxafil Capsules/US | 6 M |
| Dabigatran etexilate SR pellets 35% w/w | Tech pack | Feb’23 | Fast & Fed | PRADAXA/US | 6 M |
| Dexlansoprazole DR pellets 22.5% w/w | Tech pack | Mar’23 | Fast & Fed | DEXILANT/US | 3 M |
| Dipyridamole SR pellets 40% w/w | Tech pack | Available | Fast & Fed | AGGRENOX/US | 6 M |
| Donepezil IR pellets 11.11% w/w | Tech pack | To be done | Fast | NAMZARIC/US | 6 M |
| Esomeprazole DR pellets 22.5% w/w | Tech pack | Available | Fast | NEXIUM/EU | 12 M |
| Memantine SR pellets 14 % w/w | Tech pack | Available | Fast & Fed | NAMZARAC/US | 6 M |
| Methylphenidate HCL MR Pellets 11% | Tech pack | Available | Fast & Fed | Ritalin LA 40mg | 6 M |
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.
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 PFI facilities in Nacharam and Pashamylaram-R&D, Hyderabad support formulation development, route scouting, and process optimization. These sites enable scale-up studies and clinical supply manufacturing, with specialized modules designed to operate under cGMP conditions.
Our commercial-scale PFI manufacturing is anchored across three sites in Hyderabad. These facilities are part of a larger 3,000+ kL capacity infrastructure, with 2 dedicated pellet units offering a combined 830 MMT installed capacity. Built to global cGMP standards, several of these sites are US FDA-audited and house 7 specialized modules tailored for pelletized formulation development and scale-up. The integration of API and PFI manufacturing under one platform ensures operational consistency and delivery reliability across 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-engineer smarter PFIs for
global markets.
Contact UsResources
- Webinar: Beyond Basics – Pellets in Next-Gen Drug Delivery
- Whitepaper: PFIs for Global Markets: Bridging Science & Scalability
- Infographic: PFI Journey with Cohance: From API to Formulated 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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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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employees from around the world
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happy clients from largest corporations
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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,
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