RANCHO CORDOVA, Calif., Jan. 25, 2012/PRNewswire/ -- AMPAC Fine Chemicals LLC (AFC), a wholly owned subsidiary of American Pacific Corporation (Nasdaq: APFC), announced today that is has been granted Registration as a Manufacturer of Controlled Substances from the U.S. Drug Enforcement Agency (DEA).
AFC has been involved in the development of Schedule II Controlled Substances since 2008 under a Researcher's License from the DEA. Recent facilities upgrades have expanded AFC's capabilities to include commercial scale manufacturing of Schedule II controlled substances. This manufacturing is conducted within a high security area of AFC's Rancho Cordova, California, facilities, which are located within a Department of Defense-regulated campus.
"AFC's upgraded controlled substance facility offers a state-of-the-art, remotely operated process plant which can safely run hydrogenations and hazardous chemical processes, while containing reactants and products with Operator Exposure Limit as low as 0.5 micrograms per cubic meter. The recent upgrades satisfy DEA requirements for producing Schedule II intermediates and active pharmaceutical ingredients under current Good Manufacturing Practices (cGMP)," stated Larry Zeagler, Executive Director of Product Management for AFC.
"We are pleased to add controlled substance commercial manufacturing to the value proposition that we bring to our customers. This major milestone enhances our position as a fine chemical supplier with world-class cGMP manufacturing capabilities in the United States," stated Aslam Malik, President of AFC.
AFC's entry into the field of controlled substances is enabled by a commercial arrangement with a large pharmaceutical company. These developments position AFC for significant growth in the controlled substances area.
ABOUT AMPAC FINE CHEMICALS LLC
AFC is a U.S.-based company with demonstrated capabilities
in process development, scale-up, and cGMP-compliant
commercial production of active pharmaceutical ingredients
(API's) and registered intermediates for pharmaceutical
and biotechnology customers. Its specially engineered
facilities and experienced staff allow AFC to safely
produce highly energetic compounds at commercial scale. In
addition, AFC's other technology platforms include
production of highly potent compounds, continuous processes
and industrial-scale chromatographic separation using
simulated moving bed chromatography (SMB). AFC's
operations are located in Rancho Cordova, CA,
and in La Porte, Texas. Additional
information about us can be obtained by visiting our web
site at .
ABOUT AMERICAN PACIFIC CORPORATION
American Pacific Corporation (AMPAC) is a leading custom
manufacturer of fine chemicals, specialty chemicals and
propulsion products within its focused markets. We supply
active pharmaceutical ingredients and advanced
intermediates to the pharmaceutical industry. For the
aerospace and defense industry we provide specialty
chemicals used in solid rocket motors for space launch and
military missiles. AMPAC also designs and manufactures
liquid propulsion systems, valves and structures for space
and missile defense applications. We produce clean agent
chemicals for the fire protection industry, as well as
electro-chemical equipment for the water treatment
industry. Our products are designed to meet customer
specifications and often must meet certain governmental and
regulatory approvals. Additional information about us can
be obtained by visiting our web site at .
FORWARD-LOOKING STATEMENTS
Statements contained in this press release that are
not purely historical are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act
of 1995, Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934,
including without
limitation statements regarding anticipated
benefits and outcomes of the Registration of AFC as a
Manufacturer of Controlled Substances by the DEA. The
inclusion of forward-looking statements should not be
regarded as a representation by American Pacific
Corporation and its affiliates (collectively,
"American Pacific") that any
of American Pacific's expectations will be
achieved. Actual results may differ materially from
future results or outcomes expressed or implied by
forward-looking statements set forth in this
press release due to risks, uncertainties and other
important factors inherent in American Pacific's
business. Factors that might cause actual results to
differ include, but are not limited to, those included
in the "Risk Factors" section of the Form 10-K
for the fiscal year ended September 30, 2011,
filed by American Pacific Corporation with the U.S.
Securities and Exchange Commission. Readers of
this press release are referred to the
filings of American Pacific Corporation with
the U.S. Securities and Exchange Commission or
further discussion of these and other factors that could
affect future results. The forward-looking statements
contained in this press release are made as of the
date hereof and American Pacific assumes no
obligation to update for actual results or to update the
reasons why actual results could differ materially from
those projected in the forward-looking statements, except
as required by law.
Technical Contact: | William DuBay, Ph.D., Vice President, Technology and Business Development | |
AMPAC Fine Chemicals | ||
+1 (800) 311-9668 +1 (916) 357-6880 | ||
Investor Contact: | Deanna Riccardi | |
American Pacific Corporation | ||
+1 (702) 735-2200 |
SOURCE American Pacific Corporation
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