Navigation Links
AMRI Burlington Receives DEA Approval to Handle Controlled Substances
Date:6/18/2013

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.

(Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO)

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 www.amriglobal.com or follow us on Twitter (@amriglobal).


'/>"/>
SOURCE AMRI
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 DART™ 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:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... OXFORD, England , December 8, 2016 ... Company, has expanded its customisable SureSeq™ NGS panel range with ... - allowing fast and cost-effective study of variants in familial ... copy number variation (CNV) detection on a single small panel ... and hotspot content. This includes all exons for LDLR ...
(Date:12/8/2016)... Maryland (PRWEB) , ... December ... ... announces the commercial launch of flexible packaging for their exceptionally efficient ... disposable bag system extends RoosterBio’s portfolio of bioprocess media products engineered to ...
(Date:12/8/2016)... N.J. , Dec. 8, 2016  Soligenix, ... late-stage biopharmaceutical company focused on developing and commercializing ... an unmet medical need, announced today the long-term ... with SGX942 (dusquetide), a first-in-class Innate Defense Regulator ... in head and neck cancer patients undergoing chemoradiation ...
(Date:12/8/2016)... Dec. 8, 2016 Savannah River Remediation ... and selected NewTechBio,s NT-MAX Lake & Pond ... beneficial bacteria, in conjunction with Hexa Armor/ Rhombo ... with National Pollutant Discharge Elimination System requirements. ... a steady history of elevated pH levels, above ...
Breaking Biology Technology:
(Date:12/5/2016)... , Dec. 5, 2016  The Office of ... published "Can CT Scans Enhance or Replace Medico ... potential of supporting or replacing forensic autopsies with ... scan. In response to recommendations made ... exploring using CT scans as a potential component ...
(Date:11/29/2016)... , Nov. 29, 2016 BioDirection, a ... point-of-care products for the objective detection of concussion and ... company has successfully completed a meeting with the U.S. ... Tbit™ blood test Pre-Submission Package. During the meeting company ... system as a precursor to commencement of a planned ...
(Date:11/22/2016)... 2016 According to the new market research report ... Vein, Signature, Voice), Multi-Factor), Component (Hardware and Software), Function (Contact and Non-contact), ... market is expected to grow from USD 10.74 Billion in 2015 to ... 2016 and 2022. Continue Reading ... ...
Breaking Biology News(10 mins):