Piramal Pharma Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO) announced plans to expand its facility in Michigan with additional capacity and new capabilities for the development and manufacturing of Active Pharmaceutical Ingredients (APIs).
The company is investing ~US$32 million in the facility to keep up with expected demand based on current forecasts, including potential new opportunities.
This expansion of more than 25,000 square feet, which includes 8,500 square feet of production space, will provide significant benefits to customers and patients. Capacity will increase in large-scale manufacturing with the addition of new reactors capable of handling up to 4000L. Piramal Pharma Solutions (PPS) is also adding two new kilo labs for process development and GMP manufacture for clinical trials at scales up to 100L. New equipment of critical importance to the expansion includes a 1m2 filter dryer with glovebox technology, 3KL/4KL mild steel glass lined reactor and 3KL Hastelloy reactor, all designed to handle potent compounds with OELs >1mcg/m3. Facility design procedures assure all appropriate safety measures, including controlled room pressurizations with air locks for safe movement of both people and materials, glovebox technology/contained systems for charging and discharging of potent compounds, and a scrubber to address any reaction off-gassing.
Peter DeYoung, CEO, Piramal Pharma Solutions said, “Piramal Pharma Solutions’ Riverview facility has a well-earned reputation as the preeminent leader in high potency APIs (HPAPIs), and this expansion is designed to ensure that we retain that position. It enables us to support our customers’ immediate and long-term API needs, strengthens our presence in North America, and enhances our ability to serve patients around the world by delivering the best active ingredients in a timely manner.”
The expansion is planned to be ready for customers beginning Summer 2022. It is expected that the expansion will add approximately twenty new hires to the site, bringing the total headcount to more than 180 employees and further benefitting the local economy. This would be the seventh major acquisition or expansion by PPS in North America in the past six years demonstrating a sustained substantial commitment to patients, customers, employment, and growth.
With successful inspections by the US FDA and many European and Asian government agencies, PPS’ Riverview facility has a stellar track record of regulatory compliance and is committed to maintaining the highest possible standards of environmental performance, health and safety.
Source: Company Press Release