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Corporate - Regulatory Bodies & Rulings


Morepen DMF for anti-allergic drug

Our Bureau

NEW DELHI: Morepen Laboratoriess Ltd has submitted a Drug Master File (DMF) in the US for Desloratadine (Clarinex), an anti-allergic drug.

This is the first ever DMF filed for US market by any company since the launch of the product by its innovator. Morepen had earlier filed a DMF for the drug's basic compound Loratadine in September 1997 and had Para IV filing through its partner Novartis.

According to Mr Sushil Suri, Chairman and Managing Director, Morepen Laboratories, "The filing of US DMF for Desloratadine is particularly important for Morepen since it will help consolidate the company's hold on the Loratadine franchise in the US where it already enjoys around 90 per cent share outside the innovator."

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