Amgen Announces FDA Licensure of Two New Manufacturing Facilities

Company Continues to Meet Increased Demand for Its Novel Therapeutics

08-Sep-2005

Amgen announced the U.S. food and Drug Administration (FDA) has approved the company's new manufacturing facilities in West Greenwich, Rhode Island, and Juncos, Puerto Rico for the production of Amgen's therapeutics.

The new manufacturing plant at Amgen's Rhode Island facility has received FDA approval for the production of ENBREL (etanercept), the company's leading inflammation biologic used in the treatment of diseases such as moderate to severe rheumatoid arthritis, psoriatic arthritis and moderate to severe plaque psoriasis. Amgen's original ENBREL facility in Rhode Island received licensure in December 2002, five months after the plant was acquired by the company. Amgen has invested more than $1.1 billion to add more than 500,000 square feet to its Rhode Island campus, which now houses one of the world's largest biotechnology manufacturing facilities in terms of capacity and square footage.

Amgen's Puerto Rico facility has been licensed for commercial bulk manufacturing of NEUPOGEN (Filgrastim), the company's product used to decrease the incidence of many types of chemotherapy-related infections and Neulasta (pegfilgrastim), Amgen's product for decreasing the incidence of neutropenic infections associated with many types of cancer chemotherapy treatments. Amgen is investing $1.2 billion to expand its Puerto Rico site, first operational in 1993. In addition to the new manufacturing facility for NEUPOGEN and Neulasta, Amgen is building a second Puerto Rico facility for the production of EPOGEN (Epoetin alfa), Amgen's anemia therapy for patients with chronic renal failure on dialysis and Aranesp (darbepoetin alfa), Amgen's latest product for the treatment of anemia associated with chronic kidney disease and chemotherapy-related anemia. The complete planned expansion at Amgen's Puerto Rico campus will double the square footage of the facility - from 500,000 to one million square feet.

https://www.bionity.com/en/news/48829/amgen-announces-fda-licensure-of-two-new-manufacturing-facilities.html