With more than 40 years of CDMO industry experience, AGC Pharma Chemicals is a global CDMO specialized in API manufacturing for small molecules. Our fully cGMP-certified facilities and highly qualified teams offer end-to-end solutions that meet the highest standards of quality, safety, and regulatory compliance.
We don’t just manufacture APIs — we build long-term partnerships based on trust, flexibility, and innovation.
What Is API Manufacturing?
API manufacturing refers to the controlled production of Active Pharmaceutical Ingredients, the core component responsible for the therapeutic effect in a drug.
Our capabilities cover the entire API lifecycle, including:
- Process development and optimization
- Scale-up from grams to multi-ton volumes
- Commercial production under cGMP standards
- Regulatory support and documentation for global submissions
At AGC Pharma Chemicals, API manufacturing is not just a service — it’s our core expertise.
Why Choose AGC Pharma Chemicals for API Manufacturing?
- Fully cGMP-compliant manufacturing plants in Spain and Japan
- Decades of success with regulatory audits from FDA, EMA, and PMDA
- Expertise in high-potency APIs (HPAPIs) and micronization
- Scalable infrastructure for both clinical trials and commercial launches
- Agile and collaborative approach with flexible capabilities and a strong customer focus
Whether you’re launching a new drug or managing a mature product, we deliver reliable, compliant, and efficient API manufacturing services tailored to your needs.
Our API Manufacturing Services
AGC Pharma Chemicals offers integrated services that include:
- Route scouting and process development
- Analytical method development and validation
- HPAPI handling with appropriate containment
- Lab-scale to commercial-scale manufacturing
- cGMP micronization and particle size control
- Regulatory documentation and tech transfer
Our commitment: from molecule to market — with consistency, safety, and speed.
Technologies & Facilities
Our Technologies & facilities include:
- Hastelloy and Halar-coated reactors
- Contained production units for HPAPIs
- Cleanrooms and controlled areas for cGMP operations
- Micronization systems fully compliant with cGMP
- Comprehensive QA/QC labs and automation systems
AGC’s facilities are built for precision, scale, and global compliance.
API Manufacturing FAQ’s
1. What type of APIs do you specialize in?
We focus on small molecule APIs, including high-potency compounds, and support new chemical entities (NCEs).
2. Can AGC Pharma Chemicals handle the full lifecycle of an API?
Yes. We support all stages, from early-phase development to commercial supply, including regulatory support and tech transfer.
3. Do you offer custom API manufacturing under cGMP?
Absolutely. All of our API manufacturing services are performed under strict cGMP compliance, audited by global authorities.
Let’s Talk About Your API Manufacturing Needs
Looking for a reliable CDMO partner in API manufacturing?
Contact AGC Pharma Chemicals today to discover how we can bring your project to life with quality, compliance, and efficiency at every step.
