Only a few weeks after an Eugia manufacturing site in New Jersey received an FDA reprimand, it's set to change hands under a newly revealed transaction.
Empower Pharmacy on Monday revealed a plan to buy Eugia's new site in East Windsor. The purchase comes six weeks after the FDA cited Eugia’s site with 10 observations in a Form 483 write-up.
Empower, which produces compounded drugs, will receive Eugia’s 170,000-square-foot plant and will take over its workforce. Along with the plant sale, the companies will form a "contract manufacturing relationship," Empower said.
The site opened last year and boasts bulk manufacturing and automated fill-finish production capabilities, according to Empower.
“We anticipate welcoming the talented team in East Windsor to Empower shortly and we intend to use these capabilities to support our strategic growth initiatives,” Shaun Noorian, the CEO of Empower, said in a release.
Noorian, who founded the company in 2009, added that the acquisition of Eugia's site will allow it to meet the growing demand for compounded drugs.
Eugia is a subsidiary of generics manufacturer Aurobindo.
The manufacture of compounded drugs has come under increased attention with the surge in the popularity of diabetes and obesity drugs. The FDA allows these knockoff treatments to be produced when there is a shortage of a drug, such as the case with Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro.
In its December inspection of Eugia’s plant, the FDA found issues with a construction project that posed a contamination risk. Inspectors also found ceiling leaks and damage to an HVAC system located near an aseptic processing line. Further, the company lacked quality control documentation to prevent contamination, according to the FDA's report.
Empower did not immediately respond to a request for comment on the issues the FDA cited during its December inspection of Eugia’s site.
In 2021, Empower opened a new $55 million plant in Houston. The company called the 85,000-square-foot site one of the largest compounding facilities in the U.S.