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
|SOURCE American Pacific Corporation|
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