Aucta Pharmaceuticals Signs Commercial Manufacturing Agreement With Catalent
Catalent Pharma Solutions recently announced a commercial supply agreement for Aucta Pharmaceuticals, Inc.’s (Aucta) vigabatrin. The agreement follows a successful development program to formulate vigabatrin into a novel dosage form that employs Catalent’s proprietary FlexDose services.
Aucta’s commercial partner, Upsher-Smith Laboratories, LLC (Upsher-Smith), will launch vigabatrin for oral solution under the brand name Vigadrone, which offers patients and physicians a fully substitutable generic alternative to Sabril (vigabatrin) powder for oral solution.
Under the terms of the manufacturing agreement, Catalent undertook the FlexDose development program, integrating the development of granulated drug product with stick-pack dose design, packaging, and commercial manufacture of vigabatrin at its 166,000-square foot flagship European manufacturing facility in Schorndorf, Germany. This will be the first US FDA Abbreviated New Drug Application (ANDA) to employ Catalent’s proprietary FlexDose services, and the first to be commercialized in Schorndorf.
“Catalent has over a decade of experience in developing, manufacturing and packaging stick pack products, which offer a number of advantages to improve the convenience of dosing and patient adherence of drug products,” commented Jonathan Arnold, Catalent’s President, Oral Drug Delivery.
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 over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com
Aucta Pharmaceuticals, Inc. (AUCTA, Latin-improved, enhanced) is a technology based product company focusing on development and commercialization of niche generic and branded specialty products. The company’s corporate strategy is to focus on proven molecules, use 505(b)(2) regulatory pathway and through innovation, creating new therapeutics with lower scientific risk and meet unmet medical needs in attractive market. Its specialty division has a therapeutic focus in CNS, Dermatology and Pediatrics. For more information, visit www.auctapharma.com.
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