Zydus Cadila receives approval for Sertraline from AFSSAPS, France

Cadila Healthcare Ltd has announced having received approval from AFSSAPS, the French regulatory agency to market Sertraline capsules in 25mg and 50mg dosages. Sertraline falls in the CNS segment, in the French market.

This is the first approval for a dossier developed by the group in India and submitted in France. The annual sales of Sertraline in 2004-05 as per IMS were estimated at €70 million.

The group's subsidiary, Zydus France SAS has launched a total of 74 generic presentations since its foray in the French generics market in September last year. These include two blockbuster products, Simvastatin in the cardiovascular segment and Omeprazole in the gastrointestinal segment.

The group's operations in France have also received a boost with three site variation files already approved by AFSSAPS for transferring the production to India, thus bringing in significant cost advantage. The French generics market currently valued at US$ 2bn is one of the fastest growing markets in Europe, growing at the rate of 28.6 per cent per annum.