Catalent, Aucta Pharma Ink Commercial Mfg. Pact


Vigabatrin novel dosage form employs Catalent’s FlexDose services

Catalent Pharma Solutions has entered 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, a substitutable generic alternative to Sabril (vigabatrin) powder for oral solution.
Under 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-sq. ft. flagship European manufacturing facility in Schorndorf, Germany. This will be the first U.S. FDA Abbreviated New Drug Application (ANDA) to employ Catalent’s 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,” said Jonathan Arnold, Catalent’s president, Oral Drug Delivery.