Giovedì, 15 Aprile 2021

Alvogen and Business Partners Obtain First European Approvals for Generic Ulipristal 5mg


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.

Faysal Kalmoua, Executive Vice President of Alvogen's Global Portfolio, commented: "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. Alvogen 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."

About Alvogen

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan. North America is Alvogen's single largest market and other key markets include: South Korea, Russia, Romania, Hungary, Ukraine, Taiwan, Japan and China.

Learn more about Alvogen on

Media Enquiries:Halldor KristmannssonTel:

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Alvogen and Business Partners Obtain First European Approvals for Generic Ulipristal 5mg

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