AMRI’s Burlington, MA site has received approval to expand its current U.S. Drug Enforcement Administration (DEA) registration to handle Schedule 2 and 2N controlled substances. The Burlington site offers cGMP aseptic formulation and filling to support preclinical through commercial scale production of liquid-filled and lyophilized parenterals. The addition of Schedule 2 compounds allows Burlington to perform controlled substance work for customers, both in the lab 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."