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AMRI Announces Lifting of FDA Warning Letter Related to Burlington, Mass. Facility
Date:11/5/2013

ALBANY, N.Y., Nov. 5, 2013 /PRNewswire/ -- AMRI (NASDAQ: AMRI) announced that it has received a close-out letter from the U.S. Food and Drug Administration lifting a 2010 warning letter related to its Burlington, Massachusetts aseptic fill-and-finish facility. As a result, AMRI's Burlington, Mass. facility is in a stronger position to support our customers' commercial and development programs.

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. I would like to acknowledge and thank the many AMRI colleagues who have worked tirelessly and diligently to achieve this important milestone. 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®, a unique patented technology. With its cGMP aseptic formulation and filling expertise, AMRI Burlington supports pre-clinical through commercial scale production of liquid-filled and lyophilized parenterals. These services are provided for both small molecule drug products as well as
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