Aucta signs vigabatrin manufacturing agreement with Catalent 5th September 2018
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, yesterday announced a commercial supply agreement for Aucta Pharmaceuticals’ vigabatrin. The agreement follows a successful development program to formulate vigabatrin into a novel dosage form that employs Catalent’s proprietary FlexDoseSM services.
Aucta’s commercial partner, Upsher-Smith Laboratories, 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.