Piramal Pharma Solutions’ new active pharmaceutical ingredient (API) plant at the company’s site in Aurora, ON, has come online and successfully completed its initial production runs. 
 
The new plant, built as part of a CAD $30 million investment in the Aurora site, features more than 10,000 sq.-ft. of new manufacturing space and includes two new reactor suites with additional filtration and drying capabilities. It will support ongoing customer demand for Piramal’s 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 1mcg/m3. 
 
Since coming online, the plant has successfully implemented programs for clients that include process validation campaign, a registration campaign for clinical re-supply, and an engineering campaign. 
 

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 organization, 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 track record of regulatory compliance and is committed to maintaining gold standards of environmental performance, health & safety.