The US Drug Enforcement Agency (DEA) has rules covering the production of five classes of controlled substances. The Burlington, Massachusetts facility has registration covering 3, 3N, 4 and 5 substances, and this expansion will allows the handling of substances including a number of products defined as those with high potential for abuse, potentially leading to severe psychological or physical dependence.
The registration covers certain opiates (Schedule 2), and amphetamines (Schedule 2N) - non-narcotic but still with an abuse potential - and will complement AMRI's (Albany Molecular Research Inc) Rensselaer, NY site which is licensed to handle Schedule 1 through to 5 APIs.
Senior Director of Burlington Operations for AMRI, Christian Phillips, told Outsourcing-Pharma.com the license, though not tied to a specific contract for now, builds on the current controlled substance registration at the plant and “allows the site to bid on the larger body of available controlled substance work.”
“We continue to receive client inquiries and believe this approval puts AMRI Burlington in a competitive position to offer our services to this expanded segment of the controlled substances market,” he continued to add.
The expanded license allows AMRI to build on its Smartsourcing programme in the area of manufacturing which, according to Phillips, offers its clients “an interconnected and cross-functional global network with supporting services and the added benefits of flexibility and adaptability.”
He said: “Too often in prior years, outsourcing decisions have been driven by lowest price and not best outcomes and this has contributed to the productivity drought of the last few years.”
Therefore, he continued to add: “This latest announcement allows AMRI Burlington to offer formulation development and parenteral filling services to more of the projects that our API production units might bid, enabling customers to take full advantage of this integrated service offering.”
Burlington Bounce Back
The expansion brings good news to the site which, following revenue loss and costs to fix manufacturing issues raised in a 2010 warning letter from US Food and Drug Administration (FDA), was described as “a money pit” by Jeffries & Co. analyst David Windley.
However, AMRI’s CEO Thomas D’Ambra told stakeholders in February the facility is fully operational and was audited by perspective customers 13 times in 2012, and just awaits a final FDA audit.
Phillips confirmed this and told this publication of the boost the DEA license has given the plant:
“This accreditation is separate from FDA review, but clearly demonstrates our commitment to put in place the systems, safeguards and procedures necessary to serve our clients as a high quality partner.”