Global Presence
At MSN, our Formulation Development & Manufacturing (FDF) CDMO services are built on scientific excellence, regulatory strength, and end-to-end execution capability. Backed by world-class infrastructure and a proven global track record, we support partners across the product lifecycle from development and scale-up to commercial manufacturing and market supply.
Our flexible, quality-driven approach ensures speed, reliability, and seamless collaboration for global pharmaceutical companies.
Manufacturing Excellence
Dosage Forms
Strategic Development for Differentiated Medicines
We support clients leveraging the 505(b)[2] regulatory pathway as an efficient route to bring differentiated formulations, improved delivery systems, or repurposed drugs to market faster and more cost-effectively. With MSN’s strong regulatory expertise and commercial presence across the US, UK, Europe, and Australia, partners gain a clear advantage in achieving rapid, compliant market entry.
This makes us an ideal partner for companies developing value-added or reformulated products including innovative generics, modified-release formulations, alternative dosage forms, and enhanced delivery routes.
- Regulatory Strategy & Feasibility Assessment
- Formulation & CMC Development
- Bridging Study Design & Submission Support
- Faster Time to Market & Lower Development Cost
CDMO Services
MSN offers flexible collaboration models designed to match the scale, complexity, and continuity needs of every partner.
Dedicated R&D Labs
- Fully dedicated scientific and support teams
- Direct access to extended R&D, manufacturing, and support functions
- Long-term engagement model (5–10 years), ideal for sustained innovation pipelines
FTE-Based Model
- Scientific resources selected from partner-specified disciplines
- Typical 3-year term ensuring resource continuity with adjustable notice period
- Ideal for ongoing research commitments requiring domain-specific expertise
Fee-for-Service (FFS)
- On-demand, skill-specific scientific and technical support
- Best suited for well-defined projects with clear deliverables
- Effective for managing fluctuating demand or ad-hoc requirements
Stage-Wise Development Support
Pre-Clinical
- Feasibility assessments
- Prototype formulation design
- Process identification & early development
- Candidate selection
- IND-enabling test article preparation
Clinical
- Formulation optimization & scale-up
- Process Performance Qualification (PPQ)
- Technology transfer
- cGMP production & eCTD-ready documentation
Commercial
- cGMP manufacturing
- Reliable on-time supply
- Lifecycle management & optimization strategies
Manufacturing Excellence
MSN operates specialized, state-of-the-art facilities tailored for specific therapeutic categories and handling requirements.
Ophthalmic Facility
- Dedicated sterile block with controlled environments
- High-speed automated filling, sealing & inspection lines
- Expertise in preservative-free, multi-dose, and single-use containers
- Proven development & scale-up capabilities for global markets
Oncology Manufacturing Facility
- Highly contained OEB4+ environment
- Segregated areas for API handling, granulation, compression & coating
- Specialized systems for handling cytotoxic & high-potency molecules
- Robust safety, containment and environmental controls
Non-Oncology Facility
- End-to-end capability for tablets, capsules, liquids & semi-solids
- Large-scale commercial blocks capable of high-volume output
- Supports generic and complex formulations
- Flexible line configurations for global supply requirements
Accreditations
Connect With Us
Partner with MSN’s FDF–CDMO team to accelerate your product journey with science, speed, and precision.
