Navigation Links
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 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.

About AMRI
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).

Forward-Looking Statements
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.


'/>"/>
SOURCE AMRI
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
2. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
3. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
4. Misonix Announces New Distribution Agreement For Panama
5. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
6. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
7. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
8. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
9. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. STAAR Surgical Announces First Quarter 2012 Results Release Date and Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 2016 --> ... Inflammation Global Clinical Trials Review, H2, 2015 provides ... clinical trials landscape along with top level data ... (G7 & E7), Trial Status, Trial Phase, Sponsor ... companies involved and enlists all trials (Trial title, ...
(Date:2/11/2016)... The primary goal of this research is to analyze ... of liquid biopsy. Key information the survey seeks to ... liquid biopsy adoption amidst future users - Predominantly used ... Sample inflow to conduct liquid biopsy tests - Preference ... on. - Correlation analysis of sample type and biomarker ...
(Date:2/11/2016)... PRO-DEX, INC. (NasdaqCM: PDEX) today announced financial results ... The Company also filed its Quarterly Report on Form 10-Q ... Securities and Exchange Commission today. --> ... --> --> Net sales for the ... 95%, to $5.4 million from $2.8 million for the three ...
Breaking Medicine Technology:
(Date:2/12/2016)... FL (PRWEB) , ... February 12, 2016 , ... ... as a Service (WaaS), today announced the integration of Clarity Intelligence Platform (CIP) ... channel partners to offer real-time business intelligence (BI) to their small and medium ...
(Date:2/12/2016)... ... February 12, 2016 , ... The Jones Agency, a family owned ... Texas, is launching a cooperative charity drive with the Tarrant Area Food Bank in ... 50,000 individuals and families in need, the Tarrant County Food Bank offers hope and ...
(Date:2/12/2016)... San Ramon, CA (PRWEB) , ... February 12, 2016 , ... ... tissue donation in northern California and Nevada, announced a partnership with San Ramon Regional ... be transferred to the hospital’s facilities as a way to accommodate a more certain ...
(Date:2/12/2016)... ... February 12, 2016 , ... Mediaplanet today announces the launch ... component of “Revolutionizing Cancer Care” is distributed within the February 12 issue of ... a circulation of approximately 250,000 copies and an estimated readership of 750,000 readers. ...
(Date:2/12/2016)... ... ... US Sport Camps is pleased to announce the addition of junior golf ... the host site and directing the camps is PGA Professional and 2008 Iowa State ... recent years around Des Moines and are fortunate to have such a well-respected instructor ...
Breaking Medicine News(10 mins):