The company added 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.
According to the company, the inclusion 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.
Under DEA, 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, stated the company.
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