Ahmedabad-based Cadila Healthcare (Zydus Cadila), as part of its major plan to forey into the US market, has filed 12 abbreviated new drug applications (ANDAs) in the year 2003-04.
The group, which had started the process in November with 2 ANDA filings, has rounded off the first year with the largest number of ANDAs that was filed by an Indian company.
The group plans to step up the momentum by improving the speed of filing ANDAs, and has set a target of 16 to 18 ANDA filings in 2004-5. On the API front, the group has filed 12 DMFs so far and plans to file 16 to 18 DMFs 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.
Cadila Healthcare has already set up Zydus Pharmaceuticals USA Inc., to market finished dosage formulations to the US generic market place. The total US market for these 12 drugs is estimated at US $ 7.4 bn (2003 IMS data). The group plans to launch 9 of these 12 drugs in 2005, the market for which is estimated at US$ 3.5 bn. The remaining three drugs with an estimated market size of US$ 3.9 bn will be launched after 2005.
This new development is in line with the various initiatives that group has been undertaking in the recent months to position itself as a global pharmaceutical provider. Commenting on the announcement, Pankaj Patel, chairman and managing director of Zydus Cadila said, “Significant effort and progress has already been made to realise our plans to grow revenues from the generics markets. 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 generic market place.” The group expects to market its products in the USA from July 2005.
Zydus Cadila which aims to be amongst the top ten global generic players has set up a strong infrastructure for filings of ANDAs and DMFs. Proven chemistry capabilities, an extensive talent pool and a world-class manufacturing base have buoyed Zydus Cadila’s strategic plans to enter the US generic market where an estimated US $ 40 billion worth of branded drugs will be going off patent over the next five years.