Manufacturing Of Oncology API
Cerata Pharmaceuticals LLP operates a dedicated, high-containment Oncology API manufacturing facility, designed to handle high-potency cytotoxic compounds with precision and uncompromising safety.
Dedicated Manufacturing Blocks
1. Chemical Synthesis Block
- Multi-step organic synthesis
- Oncology intermediates
- Active Pharmaceutical Ingredients (APIs)
2. High-Potency Handling Block
- Contained operations
- Cytotoxic compounds
- Low OEL compounds
3. Crystallization & Drying Block
- ANFDs
- Vacuum tray dryers
- Rotocone dryers under containment
4. Powder Handling & Milling Block
- Micronization
- Sieving
- Blending under isolator systems
5. Utility & Support Block
- Purified water
- HVAC, chillers, steam, compressed air
- Effluent treatment
Process Expertise & R&D Support
Our in-house oncology chemistry experts combine advanced process design with validated scale-up strategies, supported by a state-of-the-art R&D center to ensure reproducible quality and commercial readiness.
Advanced Process Design
For complex oncology molecules
Validated Scale-up
From laboratory to commercial production
High Reproducibility
Consistent batch-to-batch quality
Continuous Optimization
Process optimization and yield enhancement
Technology Transfer
Seamless transfer to manufacturing units
Lifecycle Management
R&D-driven formulation support
Manufacturing Capacity & Scale
GMP-compliant oncology facility for safe, scalable, fully contained high-potency API manufacturing
Kilo-scale to Multi-ton
Reactor systems for all batch sizes
Flexible Batch Sizes
Low-dose, high-potency Oncology APIs
Fully Contained Processing
Under isolator systems
Closed-system Operations
Prevent cross-contamination
Integrated Containment
Operator safety and product integrity
High-Potency & Contained Oncology Manufacturing
- Oncology APIs require enhanced control, containment, and analytical precision.
- Cerata's oncology facility is designed to meet these specialized requirements.
Dedicated Containment Infrastructure
Isolators and glove boxes for maximum safety
Low OEL Compliance
Designed for APIs with low occupational exposure limits
Cytotoxic Compound Handling
Controlled handling of highly potent compounds
Cross-contamination Prevention
Strict cleaning validation protocols
Reproducible Synthesis
Controlled impurity profiles
Operator Safety
Controlled HPAPI processing environment
Quality Systems & Compliance
- Quality Assurance and Quality Control implemented at every stage of oncology API manufacturing.
- Fully equipped analytical laboratory for high-sensitivity testing.
- Validated, regulatory-compliant methods used for cytotoxic compounds.
Regulatory Compliance
- WHO-GMP compliant oncology manufacturing facility
- ISO 9001:2015 aligned Quality Management System
- Full batch traceability and regulatory audit readiness
Analytical Excellence
- High-sensitivity analytical methods for trace impurities
- Validated regulatory-compliant testing methods
- Advanced instrumentation for cytotoxic compounds
EHS & Environmental
- Strong EHS and environmental compliance framework
- Sustainable manufacturing practices
- Comprehensive waste management systems
Trusted by Global Pharmaceutical Leaders
With these capabilities, Cerata Pharmaceuticals LLP delivers safe, high-potency Oncology APIs trusted by multinational pharmaceutical companies, ensuring compatibility with advanced therapeutic formulations and global supply chains.