Initial production runs successfully completed
Piramal Pharma Limited’s Pharma Solutions business, a leading contract development and manufacturing organisation (CDMO), has announced that a new active pharmaceutical ingredient (API) plant at the company’s site in Aurora, Ontario, has come online and successfully completed its initial production runs.
The new plant, built as part of a $30 million capital investment in the Aurora site, features more than ten thousand square feet of new manufacturing space and includes two new reactor suites with additional filtration and drying capabilities.
It will support ongoing customer demand for Piramal Pharma Solutions’ expertise in APIs and enhances and expands the company’s ability to produce clinical to commercial scale APIs including highly potent APIs requiring an Occupational Exposure Limit (OEL) of 1 µg/m3.
Since coming online, the plant has successfully implemented programs for clients that include process validation campaign, a registration campaign for clinical resupply and an engineering campaign.
There is strong customer demand for the new plant’s capacity, with a pipeline of clinical and commercial scale projects planned for the future.
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, said: “It’s exciting to see the capacity expansion at our Aurora facility in Canada begin to deliver for our clients. We’ve achieved our objectives of strengthening our presence in Canada, adding API development and commercial support for other geographies such as North America and Europe, and supporting market demand for integrated solutions."
"As a patient-centric organisation, this is another example of our commitment to serving the patient community and reducing the burden of disease.”
With successful inspections by the US FDA, the UK MHRA and the PMDA, Piramal Pharma Solutions’ Aurora facility has a stellar track record of regulatory compliance and is committed to maintaining gold standards of environmental performance, health and safety.