Torrent Pharmaceuticals Ltd has filed 4 ANDAs and 3 DMFs as part of its launch plan for US markets. 3 ANDAs have been filed for Metformin Instant Release, Sertraline and Zolpidem, while the fourth was filed for Citalopram in the third week of March 2006.
The 3 DMFs have been filed for Sertraline, Venlaflaxin and Ropinorole in the API segment.
"Three ANDA candidates, Metformin Instant Release, Sertraline and Zolpidem are in advanced stages of review by US FDA. In fact, the US FDA will be inspecting the formulation facilities at our plant in Indrad sometime during late April. We are confident that the inspection will go off smoothly and we would get the approvals / tentative approvals for these three submissions very soon," according to the company sources.
Concurrently, the US FDA would also be reviewing the API facilities. The DMF for Sertraline is also in advanced stage of review.
According to the company release, with these developments, the company is gearing up for launching its products in US during the coming year. All the ANDAs have been filed for molecules with big market potential. While Sertraline had sales of over $ 3 billion in 2005, Metformin raked in close to $ 2 billion in revenues for its innovator. Zolpidem is another blockbuster, worth at least $ 2.5 billion during 2005, while Citalopram had revenues of close to a billion dollars.
The company would be targeting $ 5-6 million from each of the ANDA candidates during the first year of their respective launches.
US markets are a priority for the company. Currently, there are 14 projects underway for this market, while 12 new products (including those common with EU) would be taken up during 2006-'07. One of the current projects is a First-to-File (FTF) opportunity that will result in obtaining exclusive marketing rights, once launched.
To further drive its growth in overseas markets, the company will soon be opening subsidiaries in Australia, Mexico and other mature markets during 2006-'07. Currently, the company has operations in 50 countries across the globe. By adding new subsidiaries, Torrent global footprint is likely to expand substantially, concluded the release.