Aurora
The Aurora site specializes in process/route selection, process development, cGMP, and non-GMP manufacturing of APIs. The site is primarily comprised of Research and Development, Analytical Development, Analytical Services, Quality Control labs and three manufacturing areas with a total of 18 plant scale reactors ranging from 200 – 4000L. The site is supported by over 200 qualified and dedicated employees operating on a 24/7 basis.
We have a long-standing regulatory history with US FDA, Health Canada, and PMDA Japan and are fully compliant with all applicable regulations, safety, and environmental standards. The site is conveniently located 1 hour from the Toronto International Airport.
Piramal Healthcare Canada Ltd., 110 Industrial Parkway North, Aurora, Ontario L4G 3H4, Canada
Specialized Manufacturing Capabilities
- Potent APIs manufacturing (OEL > 1µg/m 3 )
- Non-GMP R&D scale-up suites, 50 – 100 L glass and glass-lined reactors
- GMP manufacturing spanning 100s’ grams to 100s’ kg scale
- GMP Kilo-lab suites, 50 – 100 L glass and glass-lined reactors
- 18 plant scale reactors (stainless steel and glass-lined) ranging between 200 – 4000 L
- Hydrogenation suite – 2 glass-lined reactors (200 L/9 bar and 800 L/5.8 bar)
- Hastelloy horizontal basket centrifuges
- Hastelloy filter-dryers
- Range of milling capabilities including wet milling
- Biotage Flash 400 chromatography kg scale
Featured Services
- Process/route selection
- API and impurity characterization and qualification program
- Process optimization and development from early clinical phase through GMP scale-up, validation, commercialization, and launch
- Analytical method development, validation, and QC services accomplished through state-of-the-art laboratory equipment
- On site stability chambers to support stability studies
- 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
Click here: Visitor Guide
Click here: Aurora Sell Sheet
Click here: Submission of the Assessment Report on Bill S211 (Financial year 1st April 2023 - 31st March 2024)