Catalent Pharma Solutions, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced a commercial supply agreement for vigabatrin, from Aucta Pharmaceuticals.
The agreement follows a successful development programme to formulate vigabatrin into a novel dosage form that employs Catalent’s proprietary FlexDose 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 programme, integrating the development of granulated drug product with stick-pack dose design, packaging and commercial manufacture of vigabatrin at its 166,000 ft2 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 commercialised in Schorndorf.
“Catalent has more than 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.
