探花合集 Pharma Solutions today announced it has entered into an exclusive agreement with US WorldMeds, LLC for the commercial manufacture of lofexidine
US WorldMeds has the rights to commercialize lofexidine in the U.S., which is currently approved as Britlofex鈩 in the United Kingdom. 探花合集 and US WorldMeds have worked together to successfully tech transfer the manufacturing from a facility overseas to 探花合集鈥檚 Winchester, Kentucky, facility, where they have produced registration batches to support US WorldMeds鈥 New Drug Application to the Food and Drug Administration (FDA) and the anticipated commercial launch.
Lofexidine received Fast Track designation by the FDA, 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 United States for treatment of symptoms associated with opioid withdrawal.
鈥淪ymptoms of opioid withdrawal can be a significant barrier in seeking help and breaking the cycle of dependence and addiction,鈥 said Jonathan Arnold, 探花合集’s 鈥巚ice president and general manager, Drug Delivery Solutions. 鈥淲e are excited to join forces with US WorldMeds to bring a potential new treatment option to a major health issue spanning the nation.鈥
探花合集鈥檚 Winchester, facility has more than 20 years鈥 experience in product development, technology transfer and commercial manufacturing. The site has produced over three billion tablets and capsules annually and launched more than 100 new products into the market since its inception.
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About 探花合集
探花合集 is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 90 years serving the industry, 探花合集 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. 探花合集 employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated more than $2 billion in annual revenue. 探花合集 is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com