AMPAC registered as manufacturer of controlled substances

Published: 27-Jan-2012

Plant upgrades extend capabilities at California facility


AMPAC Fine Chemicals, a wholly owned subsidiary of American Pacific Corporation, has been granted Registration as a Manufacturer of Controlled Substances from the US Drug Enforcement Agency (DEA).

The company said recent plant upgrades have expanded its capabilities to include commercial scale manufacturing of Schedule II controlled substances.

The Schedule II controlled substances are manufactured within a high security area of AFC's Rancho Cordova, California, US plant.

Larry Zeagler, executive director of product management at AFC, said the company’s upgraded controlled substance facility safely runs hydrogenations and hazardous chemical processes.

‘The recent upgrades satisfy DEA requirements for producing Schedule II intermediates and active pharmaceutical ingredients under current Good Manufacturing Practices (cGMP),’ he added.

AFC said its entry into the manufacture of controlled substances is enabled by a commercial arrangement with a large pharmaceutical company. The firm anticipates significant growth in the controlled substances area.

AFC carries out process development, scale-up, and cGMP-compliant commercial production of active pharmaceutical ingredients (APIs) and registered intermediates for pharmaceutical and biotechnology customers.

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