Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, April 09 2019 - 19:03
AsiaNet
Alvogen and Business Partners Obtain First European Approvals for Generic Ulipristal 5mg
PINE BROOK, New Jersey, April 9, 2019 /PRNewswire-AsiaNet/ --

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(R)* 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(R) 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 www.alvogen.com 

Media Enquiries:
Halldor Kristmannsson
Tel: +354-522-2900
halldor.kristmannsson@alvogen.com

(Logo: https://mma.prnewswire.com/media/821412/Alvogen_Logo.jpg )

Source: Alvogen
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