Route & feasibility
Route assessment, custom synthesis, KSM/key-intermediate strategy and early analytical planning.
CDMO & custom development
From key intermediates
to commercial supply.
Morepen brings chemistry, analytical science, scale-up, drug-product development, quality systems and manufacturing together in one phase-appropriate development and supply platform.
End-to-end development
One partner across
the development lifecycle.
Programs can begin with a route, key intermediate, API/drug substance challenge, analytical question, formulation requirement or technology transfer and progress toward clinical or commercial supply.
Build the process
Chemistry and process development, impurity-risk assessment, analytical methods and preclinical manufacturing support.
Clinical readiness
GMP manufacture, method validation, stability, selected drug-product development and clinical-supply support.
Scale & validate
Process scale-up, technology transfer, validation studies and commercial-readiness planning.
Supply & lifecycle
Commercial manufacturing, quality/change control, supply-chain coordination and lifecycle support.
Core service capabilities
Three scientific workstreams.
One connected program.
Key Intermediates is the lead customer-facing entry point. Drug substance/API development remains explicit within the service description.
Key Intermediates & API Development
Custom synthesis and process development from key intermediates and starting materials through drug substance/API manufacture and technology transfer.
- Key intermediates / KSM development
- Custom API and drug substance development
- Process optimisation and scale-up
- Custom and generic API manufacturing
- Technology transfer and plant fit
Drug Product Development
Formulation and development services that extend Morepen's chemistry platform into selected finished-dosage and regulatory programs.
- Pre-formulation and formulation development
- Scale-up and regulatory batches
- Clinical-supply support
- Stability programs
- Bioequivalence coordination and dossier integration
Analytical & Solid-State Services
Analytical development, impurity understanding and material-characterisation support integrated with development and manufacturing decisions.
- Method development and validation
- Impurity synthesis and characterisation
- Genotoxic impurity / ICH M7 assessment
- Solid-state and salt screening
- Stability and reference-standard work
Quality Control & AssuranceRegulatory CMCIntellectual PropertyProject ManagementSupply Chain Management
Phase-appropriate solutions
Across the drug
development cycle.
Support from early development through late development and commercial supply, with the workplan defined for each program.
Pre-clinical
Manufacturing support, analytical foundations and regulatory support
→Phase 1 & 2
Analytical methods, chemistry and process development
→Phase 3
Scale-up, technology transfer, validation and stability
→Commercial
Commercial manufacturing and lifecycle support
→This development-cycle framework illustrates potential service scope. Activities, deliverables and regulatory responsibilities are agreed program by program.
Chemistry & development expertise
Scientific depth designed
for scale-up.
Process chemistry, analytical science, impurity control and manufacturing knowledge are brought together early so development decisions consider quality, scalability and regulatory requirements.
Process chemistryChiral chemistryImpurity controlSolid-state scienceScale-upTechnology transferRegulatory CMCCommercial supply
Digital and AI-enabled development
Digital tools and AI/ML can support route assessment, data analysis, predictive evaluation and development decisions. Scientific review, data governance and human accountability remain central.
Manufacturing platform
Development connected
to commercial-scale infrastructure.
Current installed capacity is presented separately from future expansion so customers can distinguish today's platform from the roadmap ahead.
Baddi
High-volume API/CDMO manufacturing base
Masulkhana
Established API manufacturing and development base
Current installed
Total current API/CDMO reactor capacity
The expansion roadmap
Current scale.
Future milestones.
Later milestones remain forward-looking, subject to customer programs, execution and regulatory readiness.
INSTALLED
614 KL
Installed / current capacity
PLANNED
800 KL
Next milestone
PROPOSED
1000 KL
Subsequent milestone
ROADMAP
1200 KL
Longer-term roadmap
Roadmap: September 2026 AGM address. Future milestones are forward-looking and subject to customer programs, execution, regulatory readiness and formal commissioning.
Quality & regulatory compliance
Global trust is earned
through repeatable systems.
Quality, data integrity, regulatory readiness and continuity of supply are central to long-term pharmaceutical partnerships.
Four consecutive USFDA inspections reported with Nil Form 483 observations
MASULKHANA / 17 APRIL 2026
A site-specific quality milestone.
The April 2026 inspection at the Masulkhana API facility concluded without Form 483 observations. Morepen's wider regulatory footprint includes engagement across multiple regulated markets, with scope varying by site, product and filing.
Read the inspection disclosure
Flexible engagement
Start where the program
needs support.
A project may begin as a development package, analytical assignment, technology transfer or long-term manufacturing requirement. Scope, governance, confidentiality and responsibilities are defined program by program.
Development programs
Route/process development, intermediates, analytical work, formulation and regulatory support.
Technology transfer
Transfer of established routes or processes into Morepen's development and manufacturing platform.
Commercial supply
Long-duration manufacturing relationships built around quality, capacity planning and reliable supply.
Project governance
Dedicated coordination, milestone visibility, technical review and cross-functional decision-making.
Discuss your molecule or manufacturing program.
Share the development stage, chemistry, target scale and regulatory market. Confidential information follows the appropriate agreement.