Navigation Links
AMRI Burlington Receives DEA Approval to Handle Controlled Substances

ALBANY, N.Y., June 18, 2013 /PRNewswire/ -- AMRI (NASDAQ: AMRI) announced today that its Burlington, Mass., site has received approval to expand its current U.S. Drug Enforcement Administration (DEA) registration to handle Schedule 2 and 2N controlled substances. The license represents the DEA's acknowledgement of Burlington's physical security and quality systems, including inventory control and documentation.


With its cGMP aseptic formulation and filling expertise, AMRI Burlington supports pre-clinical through commercial scale production of liquid-filled and lyophilized parenterals. The addition of Schedule 2 compounds to this registration allows Burlington to perform controlled substance work for its customers, both in the laboratory and on the engineering/production side.

Steven R. Hagen, Ph.D., Senior Vice President of Pharmaceutical Development and Manufacturing at AMRI, said, "As part of its fully integrated global contract services offering, AMRI has the expertise to support cGMP production for a wide spectrum of products across platform technologies, both at the small and large scale. The DEA's recognition of the security and documentation systems at the Burlington facility is just another example of how AMRI's formulation and filling capabilities can meet the various needs of the pharmaceutical and biotechnology industries."

Dr. Hagen continued, "Receiving approval from the DEA to handle controlled substances demonstrates AMRI's continued ability to offer compliant, quality manufacturing process options to our customers. Our expanded license allows us to continue to build on AMRI SMARTSOURCING™ in the area of manufacturing."

In DEA terms, Burlington is considered a dosage form manufacturer that can package/label and repackage/relabel. This expanded registration will allow Burlington to offer filling services for Schedule 2, 2N, 3, 3N, 4, and 5 controlled substances, as well as offer these services to complement more of the projects handled by AMRI's Rensselaer site. AMRI's Rensselaer site – which provides contract cGMP manufacturing of bulk active pharmaceuticals and advanced intermediates – holds a DEA controlled substance license permitting the manufacture of Schedule 1 through 5 controlled substances.

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 or follow us on Twitter (@amriglobal).

Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. UCSB professor receives award for graphene electronics research
2. Watsons Generic Yaz(R) Receives FDA Approval
3. Quanterix Receives Funding From the Department of Homeland Security to Develop Test for Botulinum Toxin
4. Life Technologies Ion Personal Genome Machine Receives San Diegos CONNECT Most Innovative New Product Award
5. MacroGenics Receives Milestone Payment as Part of Its Global DARTâ„¢ Alliance with Boehringer Ingelheim
6. Intimate Bridge 2 Conception, Inc. Receives $4.3M
7. Pacific Meso Center Receives Generous Donation to First Free-Standing Mesothelioma Research Laboratory in Los Angeles
8. BioNeutral Group Receives $400,000 in Equity Financing
9. Amsterdam Molecular Therapeutics Receives US Orphan Designation for Hemophilia B Gene Therapy
10. Arcion Receives Notice of Allowance for US Patent for Novel Topical Lidocaine Formulation for Pain
11. Life Technologies Receives AFNOR Validation for Tests Designed to Detect Listeria Contamination in Food Samples
Post Your Comments:
(Date:11/30/2015)... and MAGDEBURG, Germany , November ... NeuroRehabilitation (ECNR) in Vienna, Austria ... European Congress of NeuroRehabilitation (ECNR) in Vienna, ... --> NovaVision, a wholly owned subsidiary of Vycor Medical, ... version of its Internet-delivered NovaVision Therapy Suite at the ...
(Date:11/30/2015)... and PETACH TIKVAH, Israel , ... BCLI ), a leading developer of adult stem ... subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded an additional ... Office of the Chief Scientist (OCS). This grant, the second ... for 2015 activities to approximately $1.8 million (approximately NIS7 million).  ...
(Date:11/27/2015)... ... November 27, 2015 , ... Pittcon is pleased ... technical presentations offered in symposia, oral sessions, workshops, awards, and posters. The ... range of applications such as, but not limited to, biotechnology, biomedical, drug discovery, ...
(Date:11/26/2015)... England , November 26, 2015 ... an innovative medical device company specializing in imaging technologies, announced ... the European Commission as part of the Horizon 2020 European ... to carry out a large-scale clinical trial in breast cancer. ...      (Logo: , --> ...
Breaking Biology Technology:
(Date:11/12/2015)... Mass. , Nov. 12, 2015  Arxspan ... Institute of MIT and Harvard for use of ... discovery information management tools. The partnership will support ... both biological and chemical research information internally and ... will be used for managing the Institute,s electronic ...
(Date:11/9/2015)... DUBLIN , Nov. 09, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) ...
(Date:10/29/2015)... , Oct. 29, 2015  The J. Craig Venter ... titled, "DNA Synthesis and Biosecurity: Lessons Learned and Options ... of Health and Human Services guidance for synthetic biology ... --> --> ... has the potential to pose unique biosecurity threats. It ...
Breaking Biology News(10 mins):