With over 60 years of experience in pharmaceutical manufacturing, AGC Pharma Chemicals stands as your cGMP and GMP certified CDMO partner of choice for the development and production of small molecule APIs and intermediates. From clinical to commercial scale, we ensure the highest quality standards in every process, backed by a strong regulatory track record and a customer-focused approach.
What Does cGMP and GMP Certified Mean?
GMP (Good Manufacturing Practice) certification ensures that pharmaceutical products are consistently produced and controlled according to quality standards. Being GMP certified means:
- Full compliance with FDA, EMA, PMDA, and other global authorities
- Thorough documentation and traceability
- Cleanroom and controlled environment production
- Risk-based quality control at every stage
cGMP (current Good Manufacturing Practice) is the latest and most rigorous framework required by regulatory authorities to ensure the identity, strength, quality, and purity of pharmaceutical products. Being cGMP certified guarantees that:
- All manufacturing processes meet FDA, EMA, and PMDA requirements
- Equipment and facilities are validated and qualified
- Procedures are fully documented and traceable
- Quality is embedded in every operation — not just tested at the end
AGC Pharma Chemicals operates under full cGMP compliance, continuously audited by global health authorities.
AGC Pharma Chemicals: cGMP and GMP Manufacturing Expertise
- Proven track record with successful inspections by global regulatory agencies
- Top Pharma Quality systems and process validation
- Strict control of raw materials and supply chain
- Continuous training of personnel in GMP best practices
We deliver pharmaceutical ingredients that you and your patients can trust.
Our cGMP and GMP Certified Services for Small Molecule APIs Include:
- Process Development & Scale-Up
- cGMP Manufacturing of APIs & Intermediates
- High-Potency API (HPAPI) Production
- Micronization under cGMP Conditions
- Regulatory Support & Documentation
From preclinical batches to commercial supply, we adapt to your project’s needs while maintaining full cGMP compliance.
Why Choose a cGMP and GMP Certified CDMO Partner Like AGC Pharma Chemicals?
Choosing a cGMP certified CDMO ensures:
- Reduced risk in your supply chain
- Smoother regulatory approvals
- Peace of mind for you and your patients
- Speed to market without compromising quality
With AGC Pharma Chemicals, you’re not just hiring a manufacturer — you’re gaining a reliable and proactive CDMO partner.
cGMP and GMP FAQ’s
1. Is AGC Pharma Chemicals currently cGMP certified?
Yes. AGC Pharma Chemicals operates under full cGMP compliance, with facilities regularly inspected and approved by authorities such as FDA, EMA, and PMDA.
2. What types of APIs do you produce under cGMP?
We specialize in small molecule APIs, including HPAPIs, with services that span from development to commercial manufacturing.
3. Can you support early-phase development under cGMP?
Absolutely. We apply cGMP principles from the earliest development stages to ensure a seamless transition to scale-up and regulatory approval.
Ready to Partner with a Certified GMP and cGMP Manufacturer?
Looking for a cGMP certified CDMO partner to develop or manufacture your small molecule API?
Contact us today to discover how AGC Pharma Chemicals can ensure regulatory compliance and product excellence from day one.
