News & Events zu Amneal Pharmaceuticals, Inc. (AMRX)AMRXAmneal Pharmaceuticals, Inc.

FDA Selects Seven Companies for PreCheck Pilot Program

The U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative "designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain." The following companies have been selected to participate in the pilot: Amneal Pharmaceutical - Amneal's facility in Long Island, NY will manufacture small molecule sterile liquid products for pain management, respiratory and ophthalmic diseases; Cellares Corp. - Cellares's facility in Bridgewater, NJ will manufacture cell-based gene therapy products for oncology and hematology diseases; Eli Lilly and Company - Eli Lilly's facility in Lebanon, IN will manufacture drug substance in support of the company's existing and future medicines; FUJIFILM Biotechnologies - FUJIFILM's facility in Holly Springs, NC will support commercial-scale cell culture biomanufacturing; Kriya Therapeutics - Kriya's facility in Durham, NC will manufacture AAV-based gene therapy products to address chronic disease conditions; Kyowa Kirin - Kyowa's facility in Sanford, NC will manufacture biotechnology drug substance for rare diseases; Regeneron Pharmaceuticals - Regeneron's facility in Saratoga Springs, NY will manufacture biotechnology drug substance, sterile injectables, and novel protein therapeutics for multiple diseases."

FDA Announces First Companies in PreCheck Pilot Program

Eli Lilly (LLY), Regeneron (REGN), Amneal (AMRX), Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first companies that will participate in the FDA's PreCheck pilot program, which will allow regulators to start reviewing new manufacturing facilities while they're under construction to catch and correct any issues, according to CNBC's Angelica Peebles, citing FDA spokesperson Benjamin Nichols.