AMRI Burlington Receives DEA Approval to Handle Controlled Substances

    AMRI Burlington Receives DEA Approval to Handle Controlled Substances

  PR Newswire

  ALBANY, New York, June 18, 2013

-- Approval to Handle Schedule 2 and 2N Controlled Substances at this location
Further Supports


ALBANY, New York, 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.

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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).

Contact: Investors: Michael Nolan, AMRI Chief Financial Officer,
+1-518-512-2261, Media - Gina Monari, AMRI Communications, +1-518-512-2512
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