20 October 2009
Synthon announces European approvals for Raloxifene
Synthon is announcing that it has successfully completed multiple decentralized procedures (DCP) for Raloxifene. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Synthon's Raloxifene 60 mg tablets are a fully generic and bioequivalent version of the brand product Evista®.

Synthon’s Raloxifene approval forms part of a rich pipeline of research projects and pending regulatory applications and is another example of its strategy to bring affordable quality alternatives to innovative products to market at the earliest possible date.
Raloxifene, a selective estrogen receptor modulator (SERM), is the active ingredient of Eli Lilly’s and Daiichi Sankyo’s branded product Evista®. Evista® is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In Europe, sales of Raloxifene were € 136 million in 2008 (IMS Midas data).

About Synthon:
Synthon is an international generic pharmaceutical company whose activities range from the chemical development and production of active substances to the pharmaceutical development and manufacturing of finished dosage forms.
The company is headquartered in the Netherlands with subsidiary companies in the USA, Chile, Australia, Argentina, Czech Republic and Spain. Synthon’s modern international API and drug product manufacturing facilities are EU-GMP and FDA approved.
Synthon licenses its products out to marketing partners in many countries worldwide.

For further information on Synthon and its products, please visit www.synthon.com.
Evista® is a registered trademark of Eli Lilly and Company.
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