Albany Molecular Research, Inc. (AMRI) Announces Lifting of FDA Warning Letter Related to Burlington, Mass. Facility
Published: Nov 05, 2013
AMRI Announces Lifting of FDA Warning Letter Related to Burlington, Mass. Facility
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 biologicals, from clinical phase to commercial scale.
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. 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.
Please visit the official AMRI Global YouTube channel to view a short video clip (https://www.youtube.com/watch?v=K95_v9K9JNU) featuring AMRI's Christian W. Phillips, Senior Director, Burlington Operations, who explains what the lifting of the warning letter means for AMRI Burlington and the global organization.
Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization offering customers fully integrated drug discovery, development and manufacturing services. For over 21 years, AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have undergone tremendous change in response to multiple challenges. This experience, a track record of success and locations in the United States, Europe and Asia now provides our customers with SMARTSOURCING, a full range of value-added opportunities providing customers informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI has also successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These statements may be identified by forward-looking words such as "may," "could," "should," "would," "will," "intend," "expect," "anticipate," "believe" and "continue" or similar words. Readers should not place undue reliance on our forward-looking statements. AMRI's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which AMRI may not be able to predict and may not be within the AMRI's control. Factors that could cause such differences include, but are not limited to: (a) the results of further FDA inspections; (b) AMRI's ability to effectively maintain compliance with applicable FDA and DEA regulations; (c) AMRI's ability to secure additional customers for its Rensselaer and Burlington facilities; and (d) those risk factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2012 as filed with the Securities and Exchange Commission on March 18, 2013 and the Company's other SEC filings. The Company does not undertake any duty to and does not intend to update any forward-looking statements contained in this press release after the date of this press release.
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