At AGC Pharma Chemicals, we operate a state-of-the-art cGMP and GMP facility dedicated to the development and manufacturing of small molecule APIs and intermediates. Backed by over 60 years of pharmaceutical expertise and a global track record of regulatory compliance, our facilities are built to ensure the highest Top Pharma Quality, safety, and reliability at every stage — from lab to commercial scale.
What Is a cGMP Facility?
A GMP facility is a manufacturing site that complies with Good Manufacturing Practice (GMP) regulations, ensuring that pharmaceutical products are consistently produced and controlled according to strict quality standards.
cGMP, or current Good Manufacturing Practice, reflects the most updated and globally harmonized guidelines required by agencies such as:
- FDA (U.S. Food and Drug Administration)
- EMA (European Medicines Agency)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Being cGMP compliant means going beyond basic standards — it ensures that facilities, equipment, processes, personnel, and records are all continuously updated and aligned with the latest regulatory expectations.
At AGC Pharma Chemicals, this is core to how we operate.
Inside AGC Pharma Chemicals’ cGMP Facilities
AGC Pharma Chemicals’ cGMP and GMP sites (Barcelona and Japan) offer:
- Fully cGMP-certified infrastructure, regularly audited by global authorities
- Stainless steel and glass-lined reactors from kilo lab to multi-ton scale
- Hastelloy and Halar-coated reactors
- Contained systems for HPAPI (High Potency API) manufacturing
- Micronization suites under cGMP compliance
- Controlled environments, cleanrooms, and in-process monitoring
- Integrated QA/QC laboratories and automation systems
We build every process on a foundation of cGMP compliance and operational excellence.
cGMP and GMP Services Offered at Our Facilities
Our cGMP and GMP facilities enables a wide range of services for API manufacturing:
- cGMP Kilolab
- cGMP Pilot Plant
- cGMP Multi-purpose manufacturing site
- cGMP Micronization plant
- R&D Center
Global Regulatory Readiness
AGC Pharma Chemicals’ cGMP and GMP facilities are trusted by some of the world’s leading pharmaceutical companies thanks to our:
- Robust quality systems and audit-readiness
- Successful regulatory inspections across the US, EU, and Japan
- Experienced regulatory affairs team supporting filings worldwide
- Long-term commitment to continuous improvement in cGMP operations
cGMP and GMP Facility FAQ’s
1. AGC Pharma Chemicals cGMP certified?
Yes. Our manufacturing facilities are fully cGMP-compliant and regularly audited by major regulatory agencies such as the FDA, EMA, and PMDA.
2. What’s the difference between GMP and cGMP?
GMP refers to general manufacturing guidelines. cGMP — “current” GMP — ensures that manufacturers are using the latest technologies, systems, and procedures to meet evolving quality standards. AGC Pharma Chemicals follows cGMP principles in every project.
3. Can you handle high-potency APIs in your cGMP facility?
Yes. We have dedicated containment areas and expertise in HPAPI manufacturing, fully aligned with cGMP requirements.
Visit Our cGMP and GMP Facility and Let’s Start Your Project Today
Contact AGC Pharma Chemicals to learn how our certified sites and expert teams can support your goals — from development to commercial production.
