CDMO Services

Overview

CARE9’s Contract Development and Manufacturing Organization (CDMO) services deliver comprehensive pharmaceutical manufacturing solutions, enabling pharmaceutical companies, startups, and generic manufacturers to bring medications to market efficiently. Our integrated platform combines state-of-the-art manufacturing facilities, regulatory expertise, and digital infrastructure to accelerate drug development from preclinical formulation through large-scale commercial production.

CDMO Service Portfolio

Drug Development Services

Formulation Development

Small molecule drug formulation optimization
Dosage form design (tablets, capsules, liquids, injectables)
Bioavailability enhancement strategies
Stability testing and shelf-life determination
Regulatory-grade documentation generation
Scale-up optimization from lab to pilot batches

Analytical & Quality Services

Method development and validation
Stability-indicating assay development
Impurity profiling and characterization
Process analytical technology (PAT) implementation
Quality by design (QbD) approach
Regulatory intelligence and compliance support

Process Development

Unit operation optimization and scaling
Process robustness and design space determination
Green chemistry and sustainable manufacturing
Cost optimization strategies
Technology transfer and documentation
Pilot batch manufacturing support

Manufacturing Capabilities

Solid Dosage Manufacturing

Tablet manufacturing (up to 100M tablets/month capacity)
Capsule filling (up to 50M capsules/month capacity)
Powder production and blending
Granulation and compression equipment
In-process quality control systems
CGMP (current Good Manufacturing Practice) compliance

Liquid Dosage Manufacturing

Oral solution and suspension production
Injectable formulation manufacturing
Sterile filling and packaging capabilities
Parenteral product lines
High-potency active pharmaceutical ingredient (HAPI) handling
Aseptic processing with 100,000 Class A cleanroom

Specialty & Complex Manufacturing

Sustained-release and extended-release formulations
Nanotechnology-based delivery systems
Liposomal and emulsion formulations
Biologics and protein manufacturing
Biosimilar manufacturing capabilities
Combination therapy formulations

Packaging & Labeling

Blister packaging (aluminum/aluminum and alu/PVC)
Bottle filling and capping
Strip and sheet packaging options
Child-resistant and tamper-evident packaging
Serialization and track-and-trace capabilities
Multilingual labeling and artwork management

Regulatory & Compliance Services

Regulatory Strategy & Submissions

Regulatory pathway planning for global markets
Dossier preparation (CTD, ANDA, NDA formats)
Regulatory liaison and communication
Post-approval change management (PACM)
Inspection preparation and support
Pharmacovigilance documentation

Quality Assurance & Compliance

cGMP facility operation and audits
SOPs and batch record management
Environmental and microbial monitoring
Change control and deviation management
Supplier audits and qualification
Continuous improvement programs

Manufacturing Facilities

Infrastructure Standards

Facility Specifications

Multiple manufacturing suites for different products
Segregated HAPI manufacturing with containment
Aseptic processing in ISO Class 5 and 6 environments
Environmental control systems (temperature, humidity, pressure)
Water purification and system integrity monitoring
Waste management and disposal systems

Quality Systems

LIMS (Laboratory Information Management System)
ERP integration for inventory and logistics
Real-time manufacturing dashboards
Batch documentation and traceability
Statistical process control (SPC) monitoring
Predictive maintenance systems

Accreditation & Certification

WHO-GMP: World Health Organization certification
US FDA: FDA approved facility
EMA: European Medicines Agency compliance
ISO 13485: Medical devices quality management
ISO 9001: Quality management system
FSSC 22000: Food safety certification
NABH: National Accreditation Board

Service Models

Full-Service CDMO Model

End-to-end development and manufacturing
From formulation through commercial production
Regulatory submission support included
Fixed-price or time-and-materials engagement
Dedicated project teams

Specialized Service Model

Specific phase manufacturing (development, pilot, or commercial)
Technology transfer from other manufacturers
Debottlenecking of existing processes
Capacity augmentation for existing partners
Cost-optimization services

Co-Development Model

Joint development with partner companies
Shared investments and revenue participation
Technology ownership agreements
Long-term partnership structures
Exclusive or non-exclusive arrangements

Capacity Leasing Model

Dedicated manufacturing lines for partners
Annual capacity agreements
Priority scheduling and responsive support
Flexible volume commitments
Managed quality and compliance

Performance Metrics

95%+ Regulatory approval rate for submissions
6-12 months Average time from formulation to pilot batch
12-18 months Time from development to commercial production
99.5% Batch conformance rate
<0.5% Rejected batch rate due to quality issues
98%+ On-time delivery of manufactured batches
<2% Product loss and waste in manufacturing
1000+ Products manufactured across portfolio
50+ countries Served with manufactured products
100% Zero critical regulatory observations in audits

Manufacturing Capacity

Current Utilization

500M+ tablets/month Monthly production capacity
200M+ capsules/month Monthly production capacity
50M+ vials/year Injectable product capacity
100+ liquid formulations/month Liquid dosage capacity
500+ SKUs Simultaneously in production
24/7 operations Continuous manufacturing capability

Scalability

Rapid scale-up From pilot to 10x batch sizes
Multi-site manufacturing For redundancy and capacity
Equipment duplication For high-demand products
Staffing flexibility For surge capacity
Supply chain redundancy For critical materials

Target Markets

Pharmaceutical Segments

Branded pharmaceutical companies
Generic pharmaceutical manufacturers
Specialty and niche product manufacturers
Biosimilar developers
Combination therapy manufacturers
Emerging market pharmaceutical companies

Geographic Markets

Africa (sub-Saharan pharmaceutical manufacturers)
South Asia (India, Bangladesh, Pakistan)
Southeast Asia (Vietnam, Indonesia, Philippines)
Latin America (Brazil, Mexico, Colombia)
Middle East and North Africa (MENA)
Eastern Europe expansion

Impact Projections

Manufacturing Expansion

₹1000+ Cr Annual manufacturing revenue potential
50-100 new products Annual manufacturing engagements
1000+ manufacturing jobs Created per CDMO facility
5-7 facilities Planned across 5 countries by 2028
2000+ SKUs Total production capacity across network

Economic Impact

5-10% Cost savings vs competitors through efficiencies
30-40% Faster time-to-market vs traditional CDMO
20-25% Higher profit margins for partner companies
₹500-1000 Cr Annual economic benefit to regions
Multiple Job categories (technical, scientific, operational)

Market Access

50+ countries Regulatory approvals facilitated
200+ products Brought to market annually
₹10,000+ Cr Value of partner company products
500,000+ patients Access to medications annually
Emerging market penetration In underserved regions

Technology & Innovation

Digital Manufacturing

Industry 4.0: IoT sensors and real-time monitoring
Predictive Analytics: Equipment failure prevention
Data Analytics: Batch performance optimization
Process Automation: Reduced manual interventions
Supply Chain Digital: Vendor integration and visibility

Advanced Manufacturing

Continuous Manufacturing: Flow chemistry and tablet making
3D Printing: Personalized medicine preparation
Nanotechnology: Advanced drug delivery formulations
Biologics: Mammalian cell culture and bioreactor systems
Green Chemistry: Sustainable and eco-friendly processes

Quality Innovation

Real-time Release Testing: Faster batch release
Blockchain Traceability: Immutable supply chain records
AI-Powered QA: Automated defect detection
Advanced Analytics: Statistical modeling for predictions
Edge Computing: On-site data processing and insights

Partnerships & Collaborations

Pharmaceutical Company Partnerships

Exclusive manufacturing arrangements
Technology transfer collaborations
Joint venture structures
Long-term supply agreements
Commercial partnerships for market expansion

Equipment & Material Suppliers

Preferred equipment vendors
Raw material sourcing partnerships
Technology licensing agreements
Innovation collaborations
Joint development initiatives

Regulatory & Scientific Partnerships

Regulatory consulting firms
University research collaborations
Industry association memberships
Quality standard development participation
Pharmaceutical training institutions

Competitive Advantages

Cost Leadership

Lowest manufacturing costs in emerging markets
Optimized processes and waste reduction
Shared infrastructure across multiple products
Flexible workforce and scalable operations
Government incentives and tax benefits

Speed to Market

Rapid development timelines
Quick regulatory submissions
Efficient manufacturing scale-up
24/7 manufacturing capabilities
Experienced project management

Quality Excellence

Industry-leading compliance records
Advanced quality systems
Continuous improvement culture
Investment in latest technology
Highly trained workforce

Regulatory Expertise

Multi-country regulatory experience
Frequent auditor interactions
Strong regulatory relationships
Comprehensive compliance programs
Proactive regulatory strategy

Future Roadmap

Biologics Expansion: Enhanced mammalian cell manufacturing
Continuous Manufacturing: Integration of continuous processes
Regional Hubs: CDMO facilities across key markets
Sustainability Focus: Carbon-neutral manufacturing by 2030
Advanced Analytics: AI-driven process optimization
Nanotechnology Scale-up: Commercial-scale nano manufacturing
Biosimilar Dominance: Largest biosimilar CDMO in emerging markets