AMRI Rensselaer is licensed by the U.S. Drug Enforcement Administration (DEA) to produce Schedule I, II, III, IV and V controlled substances.
AMRI’s Rensselaer site – which provides contract cGMP manufacturing of bulk active pharmaceuticals and advanced intermediates, has produced controlled substances such as analgesics, amphetamines, barbiturates, and anabolic steroids for more than 50 years.
AMRI Burlington, which is our aseptic fill and finish facility, is licensed by the DEA to handle Schedule II, IIN, III, IIIN, IV and V controlled substances. In DEA terms, AMRI Burlington is considered a dosage form manufacturer that can package/label and repackage/relabel. With its cGMP aseptic formulation and filling expertise, this site supports pre-clinical through commercial scale production of liquid-filled and lyophilized parenterals.
In June 2013, AMRI Burlington announced that it received an expanded registration to handle Schedule II and IIN controlled substances, which are defined as drugs with a high potential for abuse with use potentially leading to severe psychological or physical dependence. The addition of Schedule II compounds to this registration allows Burlington to perform controlled substance work for its customers, both in the laboratory and on the engineering/production side.