AMPAC Fine Chemicals Expands Into Controlled Substance Manufacturing
Thursday, Jan 26, 2012
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.
SOURCE American Pacific Corporation





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