Catalent Pharma Solutions, today welcomed OPKO Health, Inc.’s announcement that its New Drug Application (NDA) for RAYALDEE® has been approved by the US Food and Drug Administration (FDA). Learn more.
Somerset, N.J. – June 21, 2016 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today welcomed OPKO Health, Inc.’s (NYSE: OPK) announcement that its New Drug Application (NDA) for RAYALDEE® has been approved by the US Food and Drug Administration (FDA). The new treatment uses Catalent’s proprietary OptiShell® softgel capsule technology as its extended release delivery platform which allows for high-temperature encapsulation of semi-solid fill material within a non-gelatin, plant-based shell.
“We are pleased that OptiShell was selected as the optimum delivery method for OPKO’s Rayaldee and that through our close collaboration we have helped OPKO to bring the NDA for this important drug to approval on schedule,” commented Dr. Aris Gennadios, Catalent’s President, Softgel Technologies. “Catalent is pleased that Rayaldee is the first treatment to use our OptiShell technology to deliver a semi-solid fill, extended release drug.”
Rayaldee Capsules will be manufactured at Catalent’s North American Softgel Center of Excellence in St. Petersburg, FL. Catalent is currently advancing several OptiShell development programs, providing optimal solutions for challenging drug compounds contained in complex fill formulations.
OptiShell capsules utilize a patented shell derived from plant polysaccharides and are ideally suited for the encapsulation of higher melting-point fill formulations, like Rayaldee. As a result, soft capsules containing semi-solid matrices for modified-release of poorly soluble and/or poorly permeable drug compounds are now an option for drug developers. For immediate-release applications, OptiShell technology expands the range of compatible excipients available for developing lipid-based capsule formulations, providing more solutions for unique drug delivery challenges.
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Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,700 people, including over 1,000 scientists, at 31 facilities across 5 continents, and in fiscal 2015 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com