Gilead Sciences has opened a new manufacturing and packaging site in La Verne, Southern California. The new site is set to replace existing operations at the company’s facility in San Dimas, California, which manufactures, packages, and labels solid oral dosage form products.

The new campus includes a new 335,000-square-foot facility with an additional 65,000 square feet available for expansion. The site is currently pending US Food and Drug Administration approval of a secondary packaging line for AmBisome (amphotericin B) liposome for injection, Gilead’s antifungual drug, as well as continuing equipment validation activities to support further manufacturing and packaging capabilities targeted for regulatory approval in early 2019.

The facility will initially focus on the manufacture of AmBisome. Up to 14 million tablets will be packaged and up to 5 million AmBisome vials will be manufactured per year at the facility. The drug had 2016 sales of $356 million. The facility will also package, label, and distribute more than 20 of the company’s products throughout the Americas and the Pacific Rim, including its hepatitis C treatments.

The La Verne site adds to the company’s manufacturing and packaging operations. The company has facilities in Foster City, California (process research and development activities, active pharmaceutical ingredient [API] manufacturing for clinical supplies); Oceanside, California (biologics manufacturing for clinical supplies); Edmonton, Alberta, Canada (process research, scale-up, and API manufacturing); and Cork, Ireland (solid-dose tablet manufacturing and packaging).

Source: Gilead Sciences