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cGMP
Manufacturing

Manufacturing capabilities that deliver top-level pharmaceutical quality for small-molecule API development and production

Extensive Facilities

Plant Engineering Expertise from Chemical Manufacturing

Advanced Simulation Technology

Manufacturing capabilities leveraging the strengths of a chemical manufacturer

At the Chiba site, we offer ultra-low temperature reaction equipment and various reactors ranging from 1 to 15 m³, providing optimal solutions for your processes. Additionally, we utilize diverse technologies such as fluorination and hazardous reactions to support the manufacturing of your target compounds.We also possess plant engineering and simulation technologies developed through our chemical business, enhancing reliability in both equipment and manufacturing to ensure project success.
The Spain site features various reactors ranging from 1.2 to 7.4 m³ (as of December 2025) and multiple production lines. Some lines can handle up to OEB5, meeting diverse customer needs. With kilo labs (OEB5), pilot plants (OEB4), and commercial-scale facilities (up to OEB5), we enable synthesis from small quantities to large-scale production.

AGC Pharma

Features

Chiba Site

  • cGMP compliant
  • Supports APIs from development stage through commercial production
  • Inspection record: FDA – 5 times (last in 2023), PMDA – 4 times (2023)
  • No critical findings (Risk 1)
  • Environmental control level: ISO Class D cleanroom (100,000 particles/ft³)
  • OEB3 compliant
  • Wide range of reactor sizes from 1 to 15 m³, made of GL and nickel-based alloys

 

Spain Site

  • cGMP compliant
  • Supports APIs from development stage through commercial production
  • Inspection record: FDA – 7 times (last in 2023), EMA – 4 times (2024), PMDA – 8 times (2023)
  • No critical findings (Risk 1)
  • OEB4 and OEB5 compliant
AGC Pharma

Manufacturing Facilities at Chiba Site

The Chiba site features OEB3 compliance and Japan’s largest reactors up to 15 m³. With extensive regulatory inspection experience, we offer diverse equipment and skilled personnel for manufacturing.

Manufacturing Facilities at Spain Site (AGC PharmaChemicals Europe, Barcelona)

At AGC Pharma Chemicals, we integrate cutting-edge technology and equipment to provide CDMO services for API and intermediate process development and manufacturing.Our facilities are designed to ensure flexibility, scalability, and high quality, meeting a wide range of customer needs.

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