Purisys Activates Drug Master File for Nalmefene, Introducing New Solution for Acute Opioid Overdose Treatment

Athens, Georgia--(Newsfile Corp. - September 10, 2024) - Purisys LLC, a leading supplier of active pharmaceutical ingredients (APIs), contract development and manufacturing (CDMO) services, and pharmaceutical reference materials, has submitted its new commercial Drug Master File (DMF) with the US Food and Drug Administration for the active pharmaceutical ingredient nalmefene hydrochloride. The DMF number for nalmefene hydrochloride is 39767 and it is now available for reference, allowing pharmaceutical companies to incorporate Purisys' active pharmaceutical ingredient (API) in their drug development and commercialization processes, streamlining their regulatory submissions.

Nalmefene hydrochloride is used to treat opioid overdose by acting as an opioid antagonist. It can be administered orally, via injection, or intranasally. Clinical data has shown, compared to naloxone, nalmefene has a longer elimination half-life (lasts longer), and has greater bioavailability.¹,² Also, no observed dose-dependent liver toxicity has been reported.³ Nalmefene as an API can be used alongside naloxone as an additional tool for law enforcement and first responders in treating opioid overdose. Purisys' new DMF for nalmefene ensures a high-quality, US-based option for pharmaceutical companies seeking to incorporate this API into their drug development and commercialization processes.

"The activation of our DMF for nalmefene hydrochloride marks a significant milestone for Purisys," says Joshua Hoerner, General Manager and Executive Vice President of Purisys LLC. "By making nalmefene available for reference, we are both expanding our portfolio, as well as reinforcing our commitment to providing essential solutions for opioid overdose treatment that meet the highest standards of quality, efficacy and safety."

Purisys LLC has activated its new commercial Drug Master File with the U.S. FDA for the active pharmaceutical ingredient nalmefene hydrochloride.

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Nalmefene hydrochloride is used to treat opioid overdose by acting as an opioid antagonist.

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Purisys' Nalmefene hydrochloride is now available for reference and can be incorporated into pharmaceutical companies' drug development and commercialization process.