An API (Active Pharmaceutical Ingredient) is a chemical-based component of pharmacological activity, used with combination of other ingredients, to diagnose, cure, mitigate, and treat the disease.
At AGC Pharma Chemicals, our expertise lies in small molecule APIs, which are chemically synthesized and widely used in:
- Oncology
- Cardiovascular and metabolic disorders
- Respiratory diseases
- Other diseases
We manage the complete lifecycle of small molecule APIs, from route design to commercial manufacturing, with a focus on quality, scalability, and regulatory compliance.
End-to-End Solutions for Small Molecule API Development & Production
At AGC Pharma Chemicals, we specialize in the development and manufacturing of small molecule Active Pharmaceutical Ingredients (APIs). With over 40 years of experience as a CDMO company, full cGMP-certified facilities in Spain and Japan, and a proven global regulatory track record, we deliver reliable, high-quality API services from early development through commercial production.
Our Capabilities in Small Molecule APIs
AGC Pharma Chemicals offers full-service support for small molecule API development, including:
- Route scouting and process development
- Analytical development and regulatory documentation
- Handling of highly potent APIs (HPAPIs) under OEB5 containment
- Scale-up from lab to multi-ton production
- cGMP manufacturing for clinical and commercial stages
- Micronization and particle size control
All operations are conducted in dedicated small molecule API facilities built for precision, flexibility, and global quality standards.
Our facilities in Barcelona and Japan are equipped to handle a broad range of chemical processes under cGMP conditions
API FAQ’s
1. What type of APIs does AGC Pharma Chemicals manufacture?
AGC Pharma Chemicals focuses on small molecule APIs and intermediates, including high-potency APIs (HPAPIs).
2. Can AGC Pharma Chemicals support both early-stage and commercial API production?
Yes. Our infrastructure is designed for seamless scale-up from R&D through commercial manufacturing.
3. Does AGC Pharma Chemicals support global regulatory submissions?
Absolutely. We provide complete documentation and regulatory support for DMFs, CEPs, NDAs, ANDAs, and other filings.
4. Is AGC Pharma Chemicals’ API manufacturing cGMP compliant?
Yes. All our API manufacturing is conducted in certified cGMP facilities, audited by leading regulatory bodies worldwide.
Let’s Build Your API Project Together
Looking for a dependable CDMO partner for your small molecule API development and manufacturing needs?
Contact AGC Pharma Chemicals today and discover how our facilities, expertise, and regulatory strength can support your molecule — from idea to market.
