AMRI announces lifting of FDA warning letter
Thomas E. D'Ambra, Ph.D., president and CEO, said, "AMRI is pleased to report that we have resolved all issues raised by the FDA related to our Burlington, Mass. facility. This is consistent with feedback we have received from numerous customer quality audits of our Burlington site, confirming that the corrective actions, improvements and upgrades taken at this facility provide even stronger support for our growing customer list and meet the high standards necessary to successfully operate an injectable dosage form operation. Moving forward, we remain committed to maintaining our uncompromising focus on quality, culture and performance at Burlington and all of our locations worldwide."
The Burlington facility is an established provider of cGMP manufacturing and sterile filling of parenteral drugs using specialized technologies, including lyophilization and BUBBLE-FREE FILLING. With its cGMP aseptic formulation and filling experience, AMRI Burlington supports preclinical through commercial scale production of liquid-filled and lyophilized parenterals. These services are provided for both small molecule drug products as well as biologicals, from clinical phase to commercial scale.
In June, AMRI Burlington said it received an expanded registration to handle Schedule II and IIN controlled substances, defined as drugs with a high potential for abuse with use potentially leading to severe psychological or physical dependence. This expanded registration allows Burlington to offer filling services for Schedule II, IIN, III, IIIN, IV and V controlled substances, as well as offer services to complement more AMRI Rensselaer projects. 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.
AMRI is a global contract research and manufacturing organization offering fully integrated drug discovery, development and manufacturing services. With over 21 years of experience, AMRI has locations in the U.S., Europe and Asia, and provides SMARTSOURCING, a range of value-added opportunities providing customers informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline.