RANCHO CORDOVA, Calif., Feb. 14, 2012 /PRNewswire/ -- AMPAC Fine Chemicals LLC (AFC), a wholly owned subsidiary of American Pacific Corporation (Nasdaq: APFC), reports that it has joined Rx-360 as an active member. Rx-360 is a pharmaceutical and biotech industry consortium that was founded by industry leaders to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. AFC is contributing to the Rx-360's joint audit pilot program as the first U.S.-based active pharmaceutical ingredient (API) manufacturer to be audited.
AFC's ongoing focus and commitment to quality has resulted in a successful U.S. Food and Drug Administration (FDA) pre-approval inspection (PAI) for seven oncology and anti-viral products, subsequently resulting in FDA approval for several of these products. This is the latest of several successful inspections at the AFC Rancho Cordova, California, facility over the past year, including a combined FDA PAI and general inspection, and inspections by the Korean FDA (KFDA) and the European Medicines Agency (EMA).
"We continue to invest in our quality systems and this is demonstrated by our successful inspections by the FDA, KFDA and EMA. In 2011, we were also re-accredited by the Japanese PMDA," stated Jeff Robinson, Vice President of Quality and Regulatory Affairs. "With our recent inspections and active participation in Rx-360's audit program, we continue to validate our commitment to quality and transparency."
"Successful audits by various regulatory agencies coupled with AFC joining Rx-360 substantiates our commitment to Quality and to AFC's Continuous Improvement Initiative," stated Aslam Malik, President AMPAC Fine Chemicals.
Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The mission of the new organization is timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve. To learn more about Rx-360 go to the Rx-360 website at www.Rx-360.org.
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.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|
Copyright©2010 PR Newswire.
All rights reserved