Heightened regulatory environment drives AMRI’s $54m Whitehouse acq
Contract development and manufacturing organization (CDMO) AMRI continues to grow through acquisitions, announcing this week it is paying $54m (€50m) cash and $2m in shares to add Whitehouse to its Discovery and Development Services (DDS) business.
The New Jersey-based analytical firm offers a number of testing services for pharma companies, including container qualification and container closure integrity testing (CCIT) which AMRI says is currently a key issue among its customers.
“There is an increased focus by our customers on outsourcing and also a heightened regulatory environment,” Christopher Conway, SVP at AMRI told Outsourcing-Pharma.com.
“It is extremely important that outsourcing providers offer the highest levels of technical excellence to provide their customers with testing solutions that consistently deliver accurate results.”
The pharma industry began implementing CCIT after the US Food and Drug Administration (FDA) published its ‘Guidance for Industry: Container and Closure System Integrity in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products’ in February 2008, but according to Conway the Agency is looking to propose new industry protocols
“Whitehouse Labs is a distinguished leader in the container closure integrity testing space and is actively working with the FDA to improve the knowledge and effectiveness of CCIT guidelines.”
Conway told us Whitehouse meets the “increasingly complex needs” of its customers, through its devotion to quality assurance, but was unable to speak directly on the integration of the firm.
“We can say that their capabilities are complementary to the analytical services we provide and will augment our discovery, development and manufacturing services,” he said.
Moreover, “this acquisition strategically extends AMRI’s analytical service offerings in rapidly expanding area of outsourcing services.”
Over the past two years, AMRI has expanded its service offering through a number of acquisitions, most recently adding steroid API supplier Spanish Pharmaceutical Group Gadea for $174m, and manufacturing assets of Aptuit for $60m.
“Acquiring Whitehouse is in line with AMRI’s strategy of being the preeminent supplier of custom and complex drug product development and manufacturing services to both the branded and generic pharmaceutical industry,” Conway added.
“Through organic and inorganic growth, AMRI is continuing to offer our customers access to emerging state-of-the-art technologies and the assurance that they are connected with recognized thought leaders in the industry.”