Alvogen today announced that it has successfully concluded sixteen parallel registration procedures for Ulipristal tablets. Alvogen and its business partners have received regulatory clearance for its product in multiple European countries. Alvogen, together with its business partner, is the first company in Europe to obtain approval. Scientific approval has been obtained for Ulipristal 5 mg tablets.
Alvogen’s product is a generic and bioequivalent version of Esmya* tablets and has been fully developed in house by Lotus pharmaceuticals, an Alvogen subsidiary. Alvogen and its business partners have filed for marketing authorization in 16 European countries using 16 decentralized procedures.
Esmya is a drug indicated for the treatment of uterine fibroids. The product was developed by Lotus pharmaceuticals, an Alvogen affiliate and is part of a comprehensive portfolio developed and licensed out to multiple leading business partners worldwide.