Healthcare technology company Apiject Holdings Inc announced on Friday that it has signed a lease for a 30,000-square-foot pharmaceutical manufacturing facility in Apex, North Carolina.
The new facility is planned to house two advanced Blow-Fill-Seal (BFS) production lines and operate as an FDA-registered 503B outsourcing facility focused on producing essential generic injectable medicines currently on the FDA's drug shortage list. The site will also serve as the corporate headquarters of Vanguard Utility, Apiject's operational subsidiary.
Apiject recently filed a New Drug Application (NDA) in the United States for its first BFS-based prefilled injection device.
Jay Walker, Apiject chairman, said: "America's dependence on foreign sources for essential medicines is a strategic vulnerability. Reshoring critical manufacturing -- from energy and rare earth minerals to pharmaceuticals -- is a national priority. This facility represents the next step in Apiject's ongoing work to translate advanced American manufacturing technology into real domestic capacity."
Newbury Pharmaceuticals secures first Scandinavian approval for palbociclib generic
Apotex's generic Ozempic (Semaglutide Injection) receives US FDA tentative approval
DifGen and Apotex report FDA approval of generic Nintedanib Soft Gel Capsules
Dexcel Pharma's Nintedanib Capsules approved for US launch
Upsher-Smith launches generic version of Ciprodex ear drop suspension
Samsung Bioepis partners with Sandoz on up to five next-generation biosimilars
Breckenridge Pharmaceutical partners with sterile injectable manufacturer Maiva Pharma
Breckenridge Pharmaceutical launches Pomalidomide Capsules in US market
Arna Pharma signs MOU with Slate Run Pharmaceuticals
STADA and Bio-Thera Solutions receive European marketing authorisation for Gotenfia (golimumab)
DifGen Pharmaceuticals' Fluorometholone Ophthalmic Suspension, 0.1% receives FDA approval
Viatris names new chief legal officer
Alvotech signs biosimilar supply and commercialisation deals with Sandoz