Piramal Healthcare Canada Ltd., 110 Industrial Parkway North, Aurora, Ontario L4G 3H4, Canada
Piramal's Aurora site specializes in route selection, process development, and manufacturing of APIs. The site is primarily comprised of Research and Development, Analytical Development, Analytical Services, Quality Control labs and three manufacturing areas.
We have a long-standing regulatory history with the US FDA, Health Canada, and PMDA Japan and are fully compliant with all applicable regulations, safety, and environmental standards.
We provide an array of services, including process/route selection, API and impurity characterization, laboratory sample preparation, process safety studies and process development for pre-clinical and commercial supplies.
The Aurora team has experience in manufacturing a wide range of APIs, ranging from a few grams to 100s’ kg scale. We have reactor suites capable of handling both non-potent and highly potent APIs. With an excellent quality track record, the Aurora facility is fully-equipped to support all your development and commercial API needs.
We offer analytical method development, validation, and QC services accomplished through our state-of-the-art laboratory equipment
We provide consulting services for CMC regulatory submissions including INDs, NDAs and DMFs. Our team will gather, review and compile CMC information to ensure the documentation is complete and provide strategic recommendations throughout all development phases
We provide an array of services, including process/route selection, API and impurity characterization, laboratory sample preparation, process safety studies and process development for pre-clinical and commercial supplies.
The Aurora team has experience in manufacturing a wide range of APIs, ranging from a few grams to 100s’ kg scale. We have reactor suites capable of handling both non-potent and highly potent APIs. With an excellent quality track record, the Aurora facility is fully-equipped to support all your development and commercial API needs.
We offer analytical method development, validation, and QC services accomplished through our state-of-the-art laboratory equipment
We provide consulting services for CMC regulatory submissions including INDs, NDAs and DMFs. Our team will gather, review and compile CMC information to ensure the documentation is complete and provide strategic recommendations throughout all development phases
Our team offers process optimization and development from early clinical phase through GMP scale-up, validation, commercialization, and launch. Through our modern labs and R&D suites, we provide process/route selection, process safety studies and non-GMP scale-up services (10s’ grams to kilograms).
We have experience in GMP manufacturing spanning 100s’ grams to 100s’ kg scale. The facility has three manufacturing areas housing 18 reactors (SS and glass-lined) ranging from 200 – 4000L. The site also has a kg scale Biotage Flash 400 chromatography and GMP kilo-lab suites with 50-100L glass-lined reactors.
The hydrogenation suite at Aurora is a standalone facility equipped with 2 glass-lined carbon steel reactors (200L/9 bar and 800L/5.8 bar) operating in a temperature range from 20°C to 125°C.
The Aurora facility is able to support the manufacturing of potent APIs having OEL > 1ug/m3. We have dedicated manufacturing areas equipped with Hastelloy filter dryer with isolation glove box to handle containment of potent compounds.
We have a wide range of milling equipment available, with 2 SS Quadro Comill, 1 SS Fitzmill, 1 Wet mill and 1 SS Jet Pulverizer micronizer.
Our analytical services package includes analytical method validation, reference standard qualification and third party sample analysis. The site is also equipped with stability chambers to support stability studies as per ICH guidelines.
The Aurora site has successfully cleared all regulatory inspections. Our promise of good quality is reinforced by a customer-centric and patient-centric approach
With Piramal’s global network of facilities, clients can seamlessly integrate API production with KSM/RSM production and formulation development and manufacturing
The site has helped launch 15 commercial APIs till date, further highlighting our experience and commitment to delivering the highest quality drug substance.
Clients can leverage the support of our CMC consulting services for preparation of submissions required during various phases of drug development
The site was established as Torcan
The site was acquired by Piramal Pharma from Avecia Pharmaceuticals
Expansion of containment facilities and R&D scale-up. Production and warehouse sections were modified to handle high potent APIs
Increased manufacturing capacity of Plant 3 to 11,300L
Internal renovation to increase capacity in QC, IT and workstations
