Key Features of Our API Units :

Diverse API Production :

• Capable of producing small molecules, high-potent APIs (HPAPIs), biologics, and complex intermediates.

• Units dedicated to specialized chemistry, including heterocyclic compounds, nucleosides, peptides, steroids, and more.

State-of-the-Art Equipment :

• Equipped with multi-purpose reactors, vacuum dryers, centrifuges, and filter dryers for optimized synthesis and isolation.

• Dedicated API isolation and purification systems, including chromatography and distillation setups for high purity levels.

High-Potency Handling :

• Specialized high-potent API units with containment systems for handling substances with Occupational Exposure Limits (OEL) as low as 0.1 µg/m³.

• Advanced safety protocols and containment technologies like isolators, fume hoods, and negative pressure rooms.

Scale-Up and Customization :

• Facilities for small-scale research (non-GMP) and large-scale GMP manufacturing.

• Scalable processes that can transition from lab-scale synthesis to commercial production with process optimization and validation.

Integrated Analytical and Quality Control :

• Each unit has dedicated quality control labs with HPLC, GC, and spectroscopy to monitor product quality at every stage.

• In-process monitoring and comprehensive impurity profiling to ensure compliance with stringent regulatory standards.

Regulatory Compliance :

• GMP-compliant facilities for API production, ensuring adherence to FDA, EMA, and other global regulatory requirements.

• Full documentation support for regulatory filings and CMC (Chemistry, Manufacturing, and Controls) sections for drug approvals.

Custom API Development :

• Tailored API development services for new chemical entities (NCEs) and generic formulations.

• Process validation, stability studies, and technology transfer support to meet the specific requirements of each project.

Dedicated HPAPI Units :

• Specific high-potent API units designed for potent compounds like oncology drugs, hormones, and biologics.

• Rigorous OEL management protocols and safety studies to mitigate risks associated with handling high-potency substances.

Manufacturing Capabilities Breakdown :

• Drug substance Synthesis: Full-scale synthesis of NCEs with robust process development capabilities.

• Purification & Isolation: Advanced purification techniques for high-quality APIs.

• Safety Protocols: Specialized handling, containment, and waste management systems.

• Stability Studies: Comprehensive testing in compliance with ICH guidelines.

• Regulatory Filing Support: End-to-end support for CMC documentation and regulatory submissions.

With 17 CMO units for DS Manufacturing, CRAMSN Research Park offers the flexibility, expertise, and infrastructure needed to support the entire API lifecycle, from discovery and development to commercial production. We ensure your products meet the highest standards for safety, quality, and compliance.