API Manufacturing
API Manufacturing Services
By leveraging Pharmaron’s world-class chemistry expertise at our US, UK and China GMP facilities, our teams provide complete small molecule API development and manufacturing services for Phase I/II/III clinical development and commercial supply needs.
Pharmaron’s multi-purpose kilo labs, pilot plants and commercial manufacturing plants can handle advanced intermediates, regulatory starting materials and complex APIs. In addition, our independent quality assurance teams oversee API process development and manufacturing activities to ensure GMP compliance and provide customer and regulatory audit support.
Capabilities
API Manufacturing Capabilities
- Process research and development, including route and process design for both clinical development and commercial use
- Process safety assessment to establish the basis of safety
- Non-GMP starting materials and intermediates manufacturing
- GMP intermediates and API manufacturing for Phase I/II/III clinical trials
- GMP intermediates and API manufacturing for commercial supply
Reactors and Non-GMP/GMP Manufacturing
- >200 reactors globally ranging from 20-12,500L
- Temperature range: -80 to 150°C
- Glass-lined, stainless steel and Hastelloy reactors
- Different sizes and MOCs of centrifuges, filter dryers, dryers
- Environmentally-compliant waste treatment plants and solvent recovery capabilities
- Chemistry capabilities: asymmetric hydrogenations, air and moisture sensitive reactions, transitional metal catalysis, high-pressure and oxidation/reduction reactions
- High-potency API cGMP and non-GMP manufacture
- Particle engineering (micronization and crystallization capabilities)
