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Ranbaxy retains exclusivity for Diovan

Posted on 20 January 2014

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Indian pharma major  Ranbaxy is likely to announce a tie-up with a multinational company for sourcing active pharmaceutical ingredient (API) for its blood pressure drug- Diovan.

Ranbaxy enjoys a first-to-file (FTF) status over Diovan since it was off-patented in September 2012. This means they will get six months of marketing exclusivity in the market.

The company, however, hasn’t yet got a final approval from the US-FDA due to all the quality control issues that crept up at its various manufacturing plants in India. Three of their plants are under an import alert in India and the fourth one, Toansa, where they manufactured APIs has also received a Form 483 from US-FDA with certain serious observations on deviations on manufacturing compliance norms. There have been numerous manufacturing and quality compliance issues at Ranbaxy and that’s the key reason why the approval for

Diovan has been stuck for all this while. Diovon is a USD 1.5 billion hypertension drug for the US market and if Ranbaxy can materialize this, it would - analysts say - amount to about USD 200 million kind of revenue stream for Ranbaxy in the FTF period.

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