Catalent Signs Manufacturing Agreement with US WorldMeds
Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.
On Sept. 5, 2017, Catalent announced an agreement with US WorldMeds, a pharmaceutical company that develops, licenses, and markets healthcare products, for the commercial manufacture of lofexidine, an investigational drug under development to alleviate symptoms of opioid withdrawal and enable opioid discontinuation treatment.
US WorldMeds has the rights to commercialize the treatment in the United States. The drug is currently approved as Britlofex (lofexidine) in the United Kingdom. Catalent and US WorldMeds have worked together to tech-transfer the manufacturing from a facility overseas to Catalent’s Winchester, KY, facility, where Catalent has produced registration batches to support US WorldMeds’ new drug application to FDA and its commercial launch.
FDA has granted the drug fast track designation, a process designed to expedite the review of drugs that treat serious conditions and address an unmet medical need. If approved, lofexidine would be the first non-narcotic and non-addictive medication in the US for treatment of symptoms associated with opioid withdrawal, according to Catalent.
Source: Catalent
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
