AMRI has announced that its Burlington, Mass., site has received approval to expand its current U.S. Drug Enforcement Administration (DEA) registration to handle Schedule 2 and 2N controlled substances.
The license represents the DEA’s acknowledgement of Burlington’s physical security and quality systems, including inventory control and documentation.
With its cGMP aseptic formulation and filling expertise, AMRI Burlington supports pre-clinical through commercial scale production of liquid-filled and lyophilized parenterals.
The addition of Schedule 2 compounds to this registration allows Burlington to perform controlled substance work for its customers, both in the laboratory and on the engineering/production side.
Steven R. Hagen, Ph.D., Senior Vice President of Pharmaceutical Development and Manufacturing at AMRI, said, “As part of its fully integrated global contract services offering, AMRI has the expertise to support cGMP production for a wide spectrum of products across platform technologies, both at the small and large scale. The DEA’s recognition of the security and documentation systems at the Burlington facility is just another example of how AMRI’s formulation and filling capabilities can meet the various needs of the pharmaceutical and biotechnology industries.”
Dr. Hagen continued, “Receiving approval from the DEA to handle controlled substances demonstrates AMRI’s continued ability to offer compliant, quality manufacturing process options to our customers. Our expanded license allows us to continue to build on AMRI SMARTSOURCING™ in the area of manufacturing.”
In DEA terms, Burlington is considered a dosage form manufacturer that can package/label and repackage/relabel. This expanded registration will allow Burlington to offer filling services for Schedule 2, 2N, 3, 3N, 4, and 5 controlled substances, as well as offer these services to complement more of the projects handled by AMRI’s Rensselaer site.
AMRI’s Rensselaer site - which provides contract cGMP manufacturing of bulk active pharmaceuticals and advanced intermediates - holds a DEA controlled substance license permitting the manufacture of Schedule 1 through 5 controlled substances.