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 www.ampacfinechemicals.com.
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 www.apfc.com.
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
American Pacific Corporation
+1 (702) 735-2200
|SOURCE American Pacific Corporation|
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