The Aurora, Canada facility is a USFDA, Health Canada and PMDA inspected site which offers development, clinical and commercial GMP manufacturing of Active Pharmaceutical Ingredients (APIs) for complex pharmaceutical NCEs.
Specialized Capabilities
- 14 plant scale reactors ranging between 200 - 2000 L (stainless steel/glass-lined)
- Stand-alone hydrogenation facility
- Kilo lab suites, 50 - 100 L reactors
- Non-GMP scale-up suites, 50 L reactors
- Drying, milling and packaging facility
- Small scale GMP laboratory
Featured Services
- Process/route selection
- Process development for GMP scale-up
- Analytical method development, validation and stability studies
- GMP manufacturing from grams to 100s’ kg scale
- Commercial API launch• High potent APIs manufacturing
- CMC filing support
Salient Features
- State of the art lab services, production plants, and kilo-lab suites
- US FDA, Health Canada and PMDA Japan inspected, no critical observations/483s in the past 10 years
- 24/7 operation
