Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) today announced that its business partners, including Alvogen and many leading generic companies have successfully concluded 16 parallel decentralized procedures (DCP) for Ulipristal tablets. These companies have received regulatory clearance for its product in multiple European countries. This is the first approval of Ulipristal 5mg tablets in Europe.
Ulipristal 5mg tablets is a generic and bioequivalent version of Esmya® tablets indicated for the treatment of uterine fibroids. The product was developed by Lotus pharmaceuticals and is part of a comprehensive portfolio developed and licensed out to multiple leading business partners worldwide.
Robert Wessman, Chairman of Lotus, said: “We are pleased with the approval for generic Ulipristal tablets, and we look forward, with our business partners, to leading the commercialization of this important product in Europe. Lotus has a promising pipeline of in-house generic projects and pending regulatory applications across its technological platforms of complex generics including oral oncology portfolio, hormones, soft gels and value-added generics.”