Eastman's Peboc Facility In Wales, U.K., Receives FDA Clearance

Eastman Chemical Company announces that its Peboc manufacturing facility in Wales, United Kingdom, has undergone a rigorous U.S. FDA (Food and Drug Administration) inspection, and as a result, been cleared to produce a major active pharmaceutical ingredient (API). APIs are the active compounds in pharmaceutical products that produce a therapeutic effect. Achieving FDA clearance demonstrates the Peboc site's strict adherence to current Good Manufacturing Practices (cGMPs) and its commitment to the highest level of product and process quality and safety in the manufacture of pharmaceutical ingredients.

"This is a milestone for the Peboc facility," says Fred Buehler, vice president and general manager, Performance Chemicals, Eastman Chemical Company. "We can now begin to readily insert new APIs into the facility, opening an array of manufacturing opportunities for Eastman's current and potential customers in the pharmaceutical industry."

FDA inspectors spent several days at the Peboc facility giving a rigorous examination of product and process methods. In order to achieve clearance to produce the API, Eastman had to demonstrate consistency and quality at the site in a number of areas, including full traceability of raw materials, appropriately trained staff, validated processes and cleaning methods, and no risk of cross-contamination with other products.

Eastman's Peboc site is a full-service facility equipped to produce commercial quantities of a variety of specialized organic intermediates, including advanced pharmaceutical intermediates, specialized halogenating agents, and thermochromic crystals. It specializes in the provision of confidential custom synthesis for some of the world's leading pharmaceutical companies.