Besides offering filling services for Schedule 2, 2N, 3, 3N, 4, and 5 controlled substances, this expanded registration will allow Burlington to offer these services to complement more of the projects handled by AMRI’s Rensselaer site.
With the addition of Schedule 2 compounds to this registration, the company’s Burlington centre has become capable of performing controlled substance work for its customers, both in the laboratory and on the engineering/production side.
AMRI pharmaceutical development and manufacturing senior vice president Steven Hagen said that the DEA’s recognition of systems at the Burlington facility proves that its formulation and filling capabilities meet the needs of pharmaceutical and biotechnology industries.
The site currently provides pre-clinical through commercial scale production of liquid-filled and lyophilized parenterals, leveraging its cGMP aseptic formulation and filling expertise.
AMRI provides fully integrated drug discovery, development and manufacturing services to the pharmaceutical and biotechnology industries.