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.
ABOUT Rx-360
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, CAand 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.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 | |
Investor Contact: | Deanna Riccardi |
American Pacific Corporation | |
+1 (702) 735-2200 |
SOURCE American Pacific Corporation
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