Ahmedabad: Zydus Cadila ended 2003-2004 with 12 ANDA filings. This is the largest number of ANDA filings by an Indian pharma company in its first year of filing for applications.
The group has set a target of filing 16 to 18 ANDAs in 2004-5. For its active pharmaceuticals ingredients (API), the group has filed 12 DMFs so far and plans to file 16 to 18 more in the coming year. ANDA approvals for generic formulations and DMF listings for APIs are a prerequisite for any pharma company looking to enter the US generic markets.
Zydus Cadila has set up US Zydus Pharmaceuticals Inc to market finished dosage formulations to the generic market place. The total US market for these 12 drugs is estimated at US $ 7.4 billion. The group plans to launch 9 of these 12 drugs in 2005, the market size for which is estimated at US$ 3.5 billion. The remaining three drugs with an estimated market of US$ 3.9 billion will be launched after 2005.
This new development is in line with the various initiatives that the group has been taking in recent months to position itself as a global pharmaceutical company.
According to Pankaj Patel, chairman and managing director of Zydus Cadila, "Significant effort and progress has already been made to realise our plans to grow revenues from the generic drugs market. With a robust pipeline of ANDA filings, we will now be best placed to leverage our strengths in generic formulations and effectively participate in the world's largest generics market place."
The group expects to market its products in the USA from July 2005.
The US market for generics drugs is being seen as a great opportunity by Indian companies since an estimated US$ 40 billion worth of branded drugs will be going off patent in the next five years.
Zydus Cadila which has set up a strong infrastructure for filings of ANDAs and DMFs, claims that its proven chemistry capabilities, its extensive talent pool and a world-class manufacturing base will boost its plans enter the US market.