Piramal Pharma Solutions began production of initial batches of active pharmaceutical ingredients (APIs) in new reactor suites at its facility in Riverview, MI.

Project PRIME (Piramal Riverview Integrated Manufacturing Expansion) Phase 1, commenced in May of 2021.

The initial production run is the culmination of a capital expenditure of $38 million in equipment and construction costs at Piramal’s API site in Aurora, Ontario, Canada. The facility covers approximately 25,000 square feet of space and includes production, warehousing and supporting utilities. It is readily scalable to accommodate additional reactor bays, which are planned as part of Project PRIME Phase 2.

The featured technology in the new facility is 10 kl of reactor capacity accompanied by a pressure dryer filter. The reactors can produce high potency APIs (HPAPIs) with low Occupational Exposure Levels (OELs) of >1μg/m³.

The initial production batches represent the first step in a three-step process for the development and manufacturing of Phase II clinical trial materials. As part of the program, Piramal technicians are scaling up material from 10-15 kg to 75-80 kg.

“Getting Project PRIME Phase 1 online is an important milestone for Piramal Pharma Solutions and the Riverview site team,” said Peter DeYoung, CEO, Piramal Global Pharma. “It brings additional capacity to our North American offering, which we believe satisfies the market’s current high demand for APIs. It also addresses the industry trend for onshoring of drug substance production. When coupled with the recent expansion of our API capabilities in Aurora, Canada, we believe that we are ready and able to support the market with both potent and non-potent APIs, from clinical to commercial scale.”