AGC Pharma Chemicals is a global Contract Development and Manufacturing Organization (CDMO) known for its Top Pharma Quality services and capabilities throughout the entire life cycle of small molecule APIs and intermediates. As a trusted CDMO partner, quality is at the core of everything we do—combining rigorous systems, strong regulatory alignment, and deep technical expertise to ensure product safety, reliability, and compliance
At AGC Pharma Chemicals, quality is not a metric we track; it is the foundation of everything we build. As a leading Quality CDMO, we understand that the success of your drug candidate depends on the integrity of the manufacturing process. We integrate rigorous Quality by Design (QbD) principles from the initial tech transfer through to commercial launch, ensuring that every milligram produced meets the most stringent international standards.
Why Choose AGC for Quality CDMO Services?
Quality CDMOs like AGC Pharma Chemicals integrate robust Quality Management Systems (QMS), strong regulatory alignment, and continuous improvement practices to support pharmaceutical companies operating in highly regulated markets.
Our global quality management system is harmonized across our facilities in Spain and Japan. This allows for a seamless flow of data and a unified approach to regulatory challenges. Our facilities are routinely inspected by the FDA, EMA, and PMDA, and have maintaned an impeccable track record of compliance for over 20 years. We don’t just meet industry benchmarks; we set them by utilizing advanced analytical characterization and real-time monitoring to ensure process stability and product purity.
Integrated quality systems aligned with cGMP and global standards
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Lifecycle coverage from R&D support to commercial manufacturing
Advanced analytical support for confident regulatory submission
AGC Pharma Chemicals, your quality CDMO Partner for Small Molecule APIs & Intermediates
Our quality systems are designed to safeguard each phase of your project—from initial development to commercial supply. Our analytical departments offer robust capabilities that include:
- Development, optimization, and validation of analytical methods
- Comprehensive testing of raw materials, APIs, and intermediates
- Stability studies for expiry/retest period definition
- Impurity characterization and elemental evaluation
- Support for cleaning and process validation activities
Quality CDMO FAQs
1. What makes AGC Pharma Chemicals a Top Quality CDMO?
Our track record of successful regulatory inspections and our “Quality First” culture. We integrate quality into decision-making, process design, and execution across all lifecycle stages.
2. Do AGC Pharma Chemicals support quality audits from pharmaceutical partners?
Yes. We regularly host customer audits and inspections and provide full transparency into our quality systems, documentation, and operational practices.
3. How do AGC Pharma Chemicals manage changes during the API lifecycle?
All changes are handled through a formal change control process, including risk assessment, impact evaluation, and regulatory alignment when required.
4. Do AGC Pharma Chemicals apply continuous improvement to quality processes?
Yes. Our long-standing Business Process Excellence program, based on Lean and Six Sigma principles, supports continuous quality and performance improvement.
