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.
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To request samples and discuss the commercial supply of nalmefene hydrochloride, contact us through our website at https://purisys.com.
About Purisys
Headquartered in Athens Georgia, Purisys is a leading supplier of APIs, contract development and manufacturing (CDMO) services and pharmaceutical reference standards. Its 17,000-square-foot manufacturing facility and innovation center is staffed by scientists, engineers, and other professionals who have decades of experience in complex high-barrier custom synthetic chemistry. Purisys' CDMO services are designed to support the development of custom APIs for a wide range of clinical and niche commercial applications. Purisys, a subsidiary of Noramco LLC, has specialized capabilities in controlled substance APIs, possessing 6 DEA registrations encompassing 48 drug codes. Purisys stocks a catalog of more than 250 commercial reference standards that support pharmaceutical drug product development and manufacturing. To learn more about Purisys' products and services, visit https://purisys.com/.
About Noramco
Headquartered in Wilmington Delaware, Noramco is a global supplier of active ingredients (APIs) including controlled substances to the pharmaceutical industry. Noramco's APIs are used by many of the leading brand and generic pharma companies as well as small to mid- scale pharma companies. Noramco's APIs are used in over 350 products and sold in over 30 counties. Noramco manufactures APIs that are used across a broad set of indications such as ADHD, pain management and abuse treatment and prevention.
Contacts
Corporate
Purisys
Joshua Hoerner
jhoerner@purisys.com
(706) 286-8234
Media
Resource Advantage
Dan Green
dgreen@resourceadvantage.com
1 NARCAN® (naloxone hydrochloride) nasal spray. Prescribing information. Adapt Pharma, Inc; 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf
2 OPVEE® (nalmefene) nasal spray. Prescribing information. Opiant Pharmaceuticals; 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217470Orig1s000.pdf
3 Niciu MJ, Arias AJ. Targeted opioid receptor antagonists in the treatment of alcohol use disorders. CNS Drugs. 2013;27:777-787. doi:10.1007/s40263-013-0096-4
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