FDA Approves AstraZeneca's Sterile Merrem I.V. Facility

The U.S. Food and Drug Administration (FDA) has approved AstraZeneca's Newark, DE sterile facility to aseptically fill, package, and distribute Merrem I.V. (meropenem), the company's broad-spectrum antibiotic indicate for intraabdominal infections and bacterial meningitis. Production at the dedicated, 50,000 square foot, $25 million filling facility has been underway for some time and is expected to meet global demand for the drug.

The Newark sterile facility for Merrem is located on the same campus as AstraZeneca's manufacturing and distribution facilities for a number of key products, such as Nolvadex, Seroquel, Arimidex, and Diprivan. All are Zeneca drugs, which makes sense since Newark was originally a Zeneca production site. Before building the new sterile facility, Merrem was produced by contract manufacturer Marsam Pharmaceuticals Inc., a subsidiary of Schein Pharmaceuticals.

For more information: Steve Brown, AstraZeneca, 15 Stanhope Gate, London W1Y 6LN, UK. Fax: +44 20 7304 5181.

Edited by Angelo DePalma