India's Piramal adds capacity to U.S. high-potency API site

With an expansion, Piramal Pharma Solutions can now make HPAPIs with OELs down to 1mcg/m3 at the site it acquired from Ash Stevens. ( Ash Stevens )

India’s Piramal has intensified its focus on the U.S. market including buying an API producer in the Michigan several years ago. Now its CDMO, Piramal Pharma Solutions, has completed an expansion at that site where it makes high-potency active pharmaceutical ingredients (HPAPIs).

The company invested $10 million in the former Ash Stevens site in Riverview, Michigan, where it makes HPAPis with low exposure levels, adding two kilo labs as well as quality control and analysis labs. It is now capable of making HPAPIs with OELs down to 1mcg/m3.  

It has added nearly 50 jobs. It has 127 workers now but says it plans to soon have 150. 

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.

RELATED: Piramal bulks up in injectable generics, buying five drugs from J&J

“This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market,” Vince Ammoscato, Piramal VP and site head at Riverview, said in a statement

With demand for high-potency APIs growing, other CDMOs are scaling up in that arena as well. Cambrex in May opened new capacity at a site in Iowa. It can handle projects up to 300 kg. 

Piramal bought the Ash Stevens operations in 2016 for $53 million and milestones