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Synthon announces European approvals for generic Montelukast February 2009
Synthon, 03/06/09
Synthon is pleased to announce that it has successfully completed multiple decentralized procedures for its newest product within its comprehensive portfolio: Montelukast. Regulatory clearance has been obtained for Synthon's product in sixteen European countries. Registration has been obtained for multiple dosage forms including a filmcoated tablet, intended for adults aged 15 years and above, and a chewable dosage form, intended for children aged 2 -14 years. Synthon' s product is a fully generic and bioequivalent version of the oral anti-asthma and anti-allergy agent Montelukast. Synthon will market Montelukast through its marketing partners in 4 and 5 mg chewable tablets and 10 mg filmcoated tablets.
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